Monthly Archives: June 2021

As India struggles with one of the worlds worst COVID-19 outbreaks, thousands of doctors across the nation fighting to save patients amid shortages of oxygen, medicine, and vaccines wore black armbands on June 1 to call for the arrest of India's most popular yoga televangelist. Baba Ramdev, founder of a traditional medicine empire, is peddling unproven herbal pills and yoga cures for COVID-19, while calling modern drugs stupid" and blaming the countrys hundreds of thousands of coronavirus deaths on modern medicine.

But far from being fringe, Ramdev has close ties to Indias Hindu nationalist government and has enjoyed the support of the health minister. Since the pandemic began last year, Prime Minister Narendra Modis government has been aggressively promoting Ayurvedaa traditional system of medicine with deep links to Hinduism that originated 5,000 years ago and is still widely practiced by hundreds of millions of Indians. Ayurveda uses plant-derived products, yoga, diet, and behavior changes to treat the mind and body, and is included in Indias official COVID-19 management protocol as a prevention and cure for the pandemic.

Recently, as vaccination has stalled in India due to drug shortages, the government began distributing a free, unproven formulation called AYUSH 64, an Ayurvedic pill made from four herbs that the government claims has "anti-inflammatory and immunomodulatory activities. (The pill shares its name with the acronym for the government ministry of traditional medicine, which also means long life.) Some ruling party-linked lawmakers and religious groups have even advocated drinking cow urine and smearing oneself with cow dung to safeguard against the virus.

But as a second wave of the coronavirus has claimed the lives of 335,000 Indians as of June 2, according to theNew York Times, alternative remedies that lack scientific evidence of efficacy are under fire from modern medicine doctors and even some prominent Ayurveda practitioners.

Ayurveda was [Indias] first attempt at science," says M. Shafi Kuchay, an endocrinologist at the Medanta hospital in Gurugram, a technology hub outside the Indian capital. "But today it is inefficient, he says, especially in the absence of credible studies."

Hemant Toshikhane, one of Indias leading professors of Ayurveda, was among many who used to believe the ancient remedies could guard against the deadly coronavirus pandemic.

Starting in March last year, the Parul Institute of Ayurved & Research, which Toshikhane runs, distributed traditional herbs for fever and digestive disorders and medicated nasal drops to faculty and students to ward off the virus. There were some COVID-19 infections recorded last year in Waghodia, in the western state of Gujarat, where the institute is located, but none among anyone who received the kits, according to Toshikhane.

A year later, a devastating second wave of the pandemic has swept through India, bringing the number of deaths to some 4,000 people nearly every day from mid-April through May. Toshikhane dutifully handed out the herbal kits again, but this time, most people got sick anyway, he says, so I stopped.

Ayurveda, which translates from Sanskrit as knowledge of life, is based on the principle that the body is composed of the same five elements that make up the universeair, fire, water, earth, and etherrepresented in the human body as doshas,or problems, explains Toshikhane. If the three main doshasVata, Pitta and Kaphaare not balanced, it leads to diseases. Rebalancing these doshas is done by modifying lifestyle and diet. The three mental doshasSattva, Rajas, and Tamasare treated with yoga and meditation. Ayurveda practitioners also treat disease with herb- and mineral-based medicines and surgery.

But there have never been conclusive studies on the efficacy of these treatments for chronic or infectious diseases. According to the National Center for Complementary and Integrative Health, part of the U.S. National Institutes of Health, aside from treating some pains and a few symptoms of type 2 diabetes, there is little scientific evidence on Ayurvedas value for other health issues. Many studies on Ayurvedas effectiveness are small, and few are published in peer-reviewed Western medical journals.

Even so, a large majority of Indians place faith in this ancient medical system. Nearly 80 percent used Ayurveda in 2018, up from 69 percent in 2015, according to a PricewaterhouseCoopers report on the resurgence of Ayurveda in India. The report predicts the countrys Ayurveda market will grow from $2.5 billion in 2015 to $8 billion in 2022.

Indias Hindu nationalist ruling party has long touted the healing powers of yoga and Ayurveda and in 2014, soon after taking office, Prime Minister Modi upgraded a department dedicated to the study of traditional medicine to the Ministry of Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa-Rigpa and Homoeopathy, abbreviated as AYUSH. These therapies got an additional boost when the World Health Organization greenlit trials for alternative COVID-19 therapies last September. India answered the call with more than 100 different studies examining the efficacy of various traditional medicines, including everything from therapeutic yoga positions to Kadha, a type of herbal tea consumed to fight coughs and colds.

But Rajan Sharma, an orthopedic surgeon and former president of the Indian Medical Association, says the studies lack credibility because of very small sample sizes. The pilot study on AYUSH 64, for example, was led by mostly government researchers and included only 140 people. The researchers concluded the herbal pill could treat COVID-19 because another study in the Journal of Ayurveda and Integrative Medicine found it effective for influenza-like respiratory illnesses. Even Ayurveda experts are now calling this into question.

A letter in the same journal noted the AYUSH 64/influenza trial studied a mix of modern and Ayurvedic medicines, making the claims of efficacy against flu-like illness scientifically untenable since it is not possible to identify the drug that actually cured or brought relief to patients.

Doctors have warned that unscientific practices, like smearing cow dung on ones body, could be dangerous, leading to other infections, such as mucormycosis, known as black fungus. (Read about a rare black fungus infecting Indias COVID-19 patients.)

In 2008, the U.S. Food and Drug Administration cautioned Americans against using Ayurvedic products, because one-fifth were contaminated with lead, mercury, or arsenic. In 2017, the FDA had issued a safety alert against specific Ayurvedic medicines linked to two cases of lead poisoning in Michigan.

Hepatologists have long warned of the harmful effects of Ayurvedic and other traditional medicines on the liver. In a 2019 study, Jawad Ahmad, a professor of medicine specializing in liver diseases at Mount Sinai Hospital in New York,warned of rising liver injury and failure from increased use of herbal supplements, especially in Asia.

Ahmad notes peopleturn to herbal remedies because there are few options, and they want to "maximize their chances of survival," he says. "Thats just human nature."

This is exactly what happened in India. As COVID-19 cases surged, along with a shortage of hospital beds, drugs, and oxygen, so have Internet searches by those desperate for herbal remedies that might help.

Sharma, the former head of the Indian Medical Association, sees hypocrisy in pushing Ayurvedic pills and potions. Last year, when Shripad Naik, the minister of alternative medicines, tested positive for COVID-19, he opted for modern medical treatment at a private hospital.

More:

Indian doctors protest herbal treatments being touted for COVID-19 - National Geographic

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Mental health advocate Deepak Chopra wants the world to learn about the healing power of psychedelic drugs.

Chopra told Insider he had his first psychedelic trip in 1965 while in medical school. It was part of an experiment.

Recent research suggests psychedelics like psilocybin, LSD, and MDMA can reduce mental health symptoms like depression.

Visit Insider's homepage for more stories.

Deepak Chopra has championed mental health for decades, touting the benefits of meditation, mindfulness, and better sleep in his speeches, seminars and workshops.

But Chopra's passion for a healthy mind-body connection started in an unlikely place: A science lab in India, where he had LSD for the first time. Chopra told Insider the experience left him with a feeling of overwhelming compassion and "a desire to alleviate suffering."

Inspired and forever changed by his first psychedelic trip in 1965, Chopra went on to work as an endocrinologist and studied meditation with Maharishi Mahesh Yogi, the creator of transcendental meditation.

Now, the famed alternative-medicine advocate is coming full circle with a partnership between his Chopra Foundation and Mind Medicine, a clinical-stage psychedelic medicine company. Together, the organizations will increase education and research opportunities on psychedelics and mental health, Chopra said.

"My interest now is not recreational use of psychedelics. My only interest is to expand the education and the public awareness of what's happening in the field, because what's happening to the field is very dramatic right now," Chopra told Insider.

Indeed, the latest research suggests psychedelic drugs including psilocybin or "magic" mushrooms, LSD, and MDMA have the ability to alter the mind and reduce depression, anxiety, and PTSD symptoms, Insider previously reported.

Chopra first had the opportunity to try psychedelics while in medical school in India.

Story continues

He was 18 at the time, and Harvard researchers came to campus, asking for volunteers to participate in a controlled LSD experiment. LSD, also known colloquially as "acid," is a synthetically-produced psychedelic that comes in thin paper tabs placed on the tongue.

"It was the talk of the town, and I was privy to participation in a psychedelic experience," Chopra said.

So he took the drug and, as instructed, sat in front of a poster of Mother Teresa with the other participants. Chopra said he sat there for "hours" and started to feel his consciousness shift.

"I was filled with a deep, deep compassion and desire to alleviate suffering, which never left me, by the way," he said.

Though Chopra moved on to become an endocrinologist, he remained curious about human consciousness and the inner workings of the brain.

Twenty years ago, Chopra took ayahuasca, a hallucinogenic drug that contains DMT and is typically consumed in beverage form, during a ceremony in Peru. Once again, he noticed healing effects. Over the last five years, Chopra shadowed a handful of psychedelic facilitators, people who provide support and guidance while someone is on a drug trip.

When he observed people who took psychedelics to cope with chronic and deadly illnesses, he found they came out on the other side of their trips feeling more settled and at peace.

"I've seen a lot of people feel liberated from the experience and that fear [of death] goes away," Chopra said.

Read the original article on Insider

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Deepak Chopra did LSD for the first time in a Harvard lab and felt his consciousness shift while staring at a photo of Mother Teresa - Yahoo News

A Scots university has bowed to pressure and removed the name of billionaire American donors from a research unit after the family was accused of fuelling a drugs catastrophe linked to more than 400,000 deaths in the US.

Glasgow University said it has removed the Sackler name from the facility at the neurosciences building at the NHS flagship Queen Elizabeth University Hospital in the city.

Removal of the sign, which was still in place on Friday morning, came days after we told of mounting pressure from campaigners and the NHS. NHS Greater Glasgow and Clyde confirmed the sign has been taken down, adding: This is something we were supportive of.

The Sackler family made an estimated $8 billion from the highly addictive painkiller OxyContin which was unlawfully marketed in the US as safer than alternative drugs by the family pharmaceutical firm Purdue.

Institutions around the world have removed the Sackler name after taking billions of dollars of philanthropic donations, often conditional on them prominently displaying the family name. However, Glasgow and Edinburgh universities have resisted calls from campaigners to cut ties.

A glowing biography of Mortimer Sackler remains on the Glasgow University website and the institution has no plans to strip an honorary degree from the late co-founder of Purdue.

Edinburgh University has no plans to rename the Sackler Centre for Developmental Psychobiology, which was part-funded by the family.

Aamer Anwar, a human rights lawyer and former rector of Glasgow University, said: It is sickening to see the Sackler name attached to anything associated with the pursuit of medical excellence, no matter how much money they offer. The last thing any teaching hospital or university should want to be associated with is the needless deaths of hundreds of thousands from addiction and overdose.

Last week a court ruling in the US allowed Purdue to begin soliciting support for a controversial bankruptcy plan that would shield the Sackler family, who deny any wrongdoing, from litigation tied to the opioid crisis. More than 600,000 claimants will now start to receive ballots regarding the plan.

In 2019, Purdue Pharma, facing a wave of lawsuits, filed for bankruptcy before the Sacklers paid $225 million in damages. Under the new plan, the family says $4bn will be spent on addiction treatment, education and research.

Student presidents at both universities have said the institutions should stop using the Sackler name on its facilities.

Peter Gordon, a recently retired psychiatrist who campaigned for a transparent register of pharma company donations to NHS staff, said Scottish Government ministers should back them. He said: It is a disgrace the Sackler name is used by the University of Glasgow and the University of Edinburgh. It is my view this signposts to all that commercial interests have been put ahead of informed consent and patient safety.

I would hope the removal of the Sackler name, and Mortimer Sacklers honorary degree, would have the full support of the Scottish Government.

As an NHS doctor of 25 years, on a daily basis, I came across patients who were suffering from the effects of dependence on prescribed painkillers such as OxyContin. They took these drugs in good faith but found they could not stop without withdrawal effects, which could be very severe and protracted. My overall fear is that prescribed harm will continue to rise and that even more lives risk being ruined.

Ian Hamilton, associate professor in addiction at York University, said: The Sackler name should be removed because this research is being funded on profits made from a drug that led to many people dying prematurely due to overdose. It is buying respectability by funding research into debilitating diseases but you have to ask yourself how clean the money is. Essentially, it is on the backs of numbers of Americans who died through overdoses.

Politicians have also called on the universities to stop using the Sackler name. Conservative MSP Miles Briggs has asked Health Secretary Humza Yousaf to intervene.

Briggs said: It is clear that pressure is mounting on Glasgow and Edinburgh Universities to seriously consider the appropriateness of their relationship with Sackler and remove the name and strip Mortimer Sackler of his honorary degree. Its unacceptable for organisations to bury their heads in the sand.

I will write to Health Secretary Humza Yousaf to ask him if he will hold talks with the universities to demand the removal of the Sackler name.

Edinburgh West MP Christine Jardine, a former Glasgow University student, said: Its sending the wrong message for Scotland to be honouring those whose work has been linked to the addiction crisis in the US and around the world.

Former MSP Dorothy Grace Elder, who is secretary of the Cross Party Group on Chronic Pain in the Scottish Parliament, said: All the dirty money should be given to aid for the victims, but without glorifying the Sackler name.

Glasgow University said: Public acknowledgment of Sackler funding has been removed from QEUH facilities.

Edinburgh University said: We have received no funding from the Sackler Trust in over two years and can confirm that we do not have any buildings bearing the Sackler name.

We have representation from Edinburgh University Students Association on the University Committee, which considers and advises on whether the source and purpose of prospective donations and philanthropic fundraising are ethically acceptable and will, of course, be open to discussing any proposals they wish to make there.

Last week, the Sackler family said: Our focus is on concluding a resolution to litigation that will signal the beginning of a far-reaching effort to deliver help to people and communities in need. Once confirmed, it provides for the Sackler families to pay $4.275bn, in addition to dedicating the value of their ownership of Purdue, all of which will fund life-saving overdose reversal and addiction treatment medicines, as well as important programmes dedicated to prevention, education and research.

Glasgow Universitys online tribute to Mortimer Sacker

Despite removing his familys name from the research facility named after them, fulsome tribute is paid to Mortimer Sackler on Glasgow Universitys website.

The tribute does not mention OxyContin or how it was accused of fuelling US drugs catastrophe linked to more than 400,000 deaths

Dr Mortimer Sackler (1916-2010) was an American physician and entrepreneur. He was chairman and co-chief executive of Purdue Pharma, a leading American pharmaceuticals company. Alongside his brothers Arthur and Raymond, he used his fortune from the pharmaceutical industry to become a prominent philanthropist and he greatly supported the University of Glasgow.

Sackler was born on 7th December 1916 in Brooklyn to Isaac and Sophie (nee Greenberg), Polish Jewish immigrant Brooklyn grocers.

After attending Erasmus Hall High School, Sackler sailed to the UK in 1937 and, with the help of Glasgows Jewish community, enrolled at Andersons College of Medicine, an institution that became part of the University of Glasgow in 1947. He attended the College between 1937-1939.

His brothers Arthur and Raymond also studied at Andersons College in the years 1937-39 and 1938-40 respectively. Mortimer Sackler was prevented from finishing his degree at the University by the outbreak of the Second World War and finished his MD degree in Massachusetts. Dr Mortimer Sackler and his brothers bought the New York pharmaceuticals company Purdue Frederick Co in 1952. All three were research psychiatrists.

Mortimer Sackler received an honorary degree from the University of Glasgow in 2001 for his support of the University. He funded the Sackler Institute of Psychobiological Research, a research unit at the Southern General Hospital which investigates neuro-psychiatric disorders in association with the Sackler Institute at the University of Edinburgh. The Institute was opened in 2004.

Dr Mortimer Sackler died on 24th March 2010.

See more here:

Glasgow University bows to pressure and removes name of billionaire donors accused over US drugs catastrophe - The Sunday Post

by Dr. J. Hareendran Nair

India is witnessing a second wave of coronavirus, with daily Covid-19 cases rising exponentially in the country. The rapid mutation of the virus and never-ending new strains have now become more severe and it is hard to tell, how this situation will manifest in future. This rise in Covid-19 cases has put a toll on the healthcare system, leading to uncertainty in the minds of the people. While government is taking requisite steps to ensure vaccination is ramping up in the country, there is still a long road to recovery.

This has led to a renewed focus on alternative natural therapies and lifestyle changes that will help the body cope with this deadly virus. Given Indias rich history in traditional medicine - the need of the hour is to look at innovative approaches and solutions. The Central governments impetus on Ayurveda drugs formulated to treat Covid-19 across the nation comes at the most appropriate time when more than 22 million people in the country are affected by the virus and the entire administrative and healthcare machinery are at work 24/7 to slow down the spread of the pandemic. The initiative of the Ministry of Ayush is a recognition and encouragement to hundreds of researchers and practitioners from traditional streams of medicine who have been relentlessly working towards finding a cure for Covid-19 as part of the Atmanirbhar drive.

I have been a practitioner and researcher of Ayurveda since the early 80s and have encountered different types of fevers (Jwaras) and is well aware of the ways in which Ayurveda deals with the diagnosis, pathophysiology, classification, management, prognosis and treatment of fevers and pandemics. I have also experienced how the medicines and its composition evolved according to the changing requirements of the environment and patients lifestyle and physique.

I have been working with a team of researchers to evolve a system that solves health problems through an approach based on the protocols of western medicine on formulas based on herbal origin. All the drugs that we formulate in our laboratory goes through stringent testing including toxicity studies which is published. Our research aims at discovering the reasons for the imbalances that a disease can cause the body and formulate poly-herbal drugs that address the external element that causes the detrimental effect.

The medicines that have been introduced are aimed at restoring respiratory health and have proven to be effective in clinical trials on patients affected by the disease. The move by the government to distribute drugs that have been proven effective comes at the most opportune time when the nation is struggling from a massive surge of the disease.

Moreover, as many studies have shown integrative therapy using Ayurveda and Yoga have proven to be effective even for Covid 19 positive patients with multiple comorbidities. As a practitioner of modern Ayurveda medicine, I would recommend the use of integrative therapy using Ayurveda and western medicine for emergency treatment for patients who are affected by Covid-19. There have been a few studies based on this which are available for the public.

And finally, it is heartening to note that India is walking the path of the countries from South East Asia where traditional systems of medicines have been treated on a par with Modern Western medicine. Almost all the countries have displayed remarkable level of success in curbing the pandemic.

To conclude, India and other nations of the world have to note the example of countries in the South Asian region where traditional systems of medicines are an integral part of their treatment system. Almost all the countries in the region have weathered the pandemic with remarkable success and the use of traditional systems of knowledge have a large role to play in the manner in which people in these areas have overcome the crisis and managed to put their economies back in the growth path.

Continue reading here:

Efficacy of traditional medicine to combat Covid-19 pandemic - ETHealthworld.com

DetailsCategory: AntibodiesPublished on Friday, 04 June 2021 11:16Hits: 565

KEYNOTE-564 is the First Phase 3 Study to Show Positive Results for Adjuvant Immunotherapy in RCC

First-Time Disease-Free Survival Data to be Presented During Plenary Session at the 2021 ASCO Annual Meeting

KENILWORTH, NJ, USA I June 3, 2021 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced first-time results from the pivotal Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Mercks anti-PD-1 therapy, for the potential adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy (surgical removal of a kidney) or following nephrectomy and resection of metastatic lesions. After a median follow-up of 24.1 months (14.9-41.5), KEYTRUDA demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 32% compared to placebo (HR=0.68 [95% CI, 0.530.87]; p=0.0010). Additionally, a favorable trend in overall survival (OS) was observed with a 46% reduction in the risk of death with KEYTRUDA as compared to placebo (HR=0.54 [95% CI, 0.300.96]; p=0.0164). As previously announced, the trial will continue to evaluate OS, a key secondary endpoint.

With the results of KEYNOTE-564, pembrolizumab is the first immunotherapy to show a clinical benefit in the adjuvant setting in kidney cancer, said Dr. Toni K. Choueiri, director of the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and professor of medicine at Harvard Medical School. It took several decades to achieve this milestone. We hope to build on this important research and provide new treatment options to kidney cancer patients.

As nearly half of early-stage renal cell carcinoma patients experience disease recurrence after surgery, we are particularly encouraged to see that KEYTRUDA demonstrated a statistically significant reduction in the risk of recurrence or death by 32% compared with placebo in this study, said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. These data highlight the opportunity for KEYTRUDA to become a new standard of care for patients with early-stage renal cell carcinoma and we look forward to working closely with regulatory authorities to make this treatment option available to patients.

The late-breaking results will be presented in the Plenary session of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #LBA5) on Sunday, June 6, 2021. As announced, data spanning more than 20 types of cancer will be presented from Mercks oncology research program at ASCO. A compendium of presentations and posters of Merck-led studies will be posted by Merck on Friday, June 4 at 9 a.m. ET. Follow Merck on Twitter via @Merck and keep up to date with ASCO news and updates by using the hashtag #ASCO21.

Merck is continuing to study KEYTRUDA, in combination or as monotherapy, as well as other investigational products across multiple settings and stages of RCC including adjuvant and advanced or metastatic disease through our broad clinical development program, which includes over 20 clinical studies and more than 4,000 patients.

KEYTRUDA is currently approved in the U.S., Europe and Japan in combination with axitinib for the first-line treatment of patients with advanced RCC.

Study Design and Additional Data from KEYNOTE-564

KEYNOTE-564 is a randomized, double-blind, Phase 3 trial (ClinicalTrials.gov, NCT03142334) evaluating KEYTRUDA monotherapy versus placebo for the adjuvant treatment of patients with RCC who have undergone nephrectomy and who have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) RCC with clear cell component. The study enrolled 994 patients who were randomized to receive either KEYTRUDA (200 mg intravenously [IV] on Day 1 of each three-week cycle for up to 17 cycles) or placebo (saline solution IV on Day 1 of each three-week cycle for up to 17 cycles). The primary endpoint is disease-free survival (DFS), and the secondary endpoints include OS and safety.

As of data cutoff (Dec. 14, 2020), the median study follow-up was 24.1 months. Findings showed KEYTRUDA demonstrated a statistically significant improvement in DFS in patients with RCC following nephrectomy or following nephrectomy and resection of metastatic lesions compared with placebo (HR=0.68 [95% CI, 0.530.87]; p=0.0010). Additionally, the two-year estimated DFS rate was 77.3% with KEYTRUDA versus 68.1% with placebo. Overall, the DFS benefit was consistent across subgroups. Median DFS was not achieved in either treatment arm based on event accrual.

Grade 3-5 treatment-related adverse events (TRAEs) occurred in 18.9% of patients in the KEYTRUDA arm and 1.2% of patients in the placebo arm. TRAEs resulting in discontinuation of any treatment occurred in 17.6% of patients in the KEYTRUDA arm and 0.6% of patients in the placebo arm. The most common TRAEs of any grade (occurring in 5% of patients) were fatigue (20.3%), pruritus (18.6%) and hypothyroidism (17.6%) in the KEYTRUDA arm and fatigue (14.3%), pruritus (11.5%) and diarrhea (10.3%) in the placebo arm. The most common immune-mediated adverse events of any grade (occurring in 3% of patients) were hypothyroidism (21.1%) and hyperthyroidism (11.9%) in the KEYTRUDA arm and hypothyroidism (3.6%) in the placebo arm. No treatment-related deaths occurred.

About Renal Cell Carcinoma (RCC)

Renal cell carcinoma (RCC) is by far the most common type of kidney cancer; about nine out of 10 kidney cancers are RCCs. Renal cell carcinoma is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Worldwide, it is estimated there were nearly 431,300 new cases of kidney cancer diagnosed and almost 179,400 deaths from the disease in 2020. In the U.S. alone, it is estimated there will be nearly 76,100 new cases of kidney cancer diagnosed and almost 13,800 deaths from the disease in 2021.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,400 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS 10), as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Carcinoma

KEYTRUDA, in combination with trastuzumab, and fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either:

Cervical Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Triple-Negative Breast Cancer

KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Mercks Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit http://www.merck.com/clinicaltrials.

About Merck

For 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the worlds most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit http://www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Please see Prescribing Information for KEYTRUDA (pembrolizumab) at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf and Medication Guide for KEYTRUDA at http://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_mg.pdf.

SOURCE: Merck

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