Monthly Archives: May 2022

Turning Point Therapeutics, Inc.

SAN DIEGO, May 10, 2022 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage precision oncology company designing and developing novel targeted therapies for cancer treatment, today announced the U.S. Food and Drug Administration (FDA) granted an eighth regulatory designation, and third Breakthrough Therapy designation, to lead drug candidate repotrectinib.

Breakthrough Therapy designation (BTD) was granted for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with one ROS1 tyrosine kinase inhibitor and who have not received prior platinum-based chemotherapy. The efficacy analyses supporting the BTD application included approximately 50 patients pooled from the Phase 1 and Phase 2 portions of the TRIDENT-1 study. Efficacy evaluations in Phase 2 patients were by physician assessment.

We are excited to receive our third BTD and eighth overall FDA regulatory designation for repotrectinib in an indication where there are no approved targeted therapies, said Mohammad Hirmand, M.D., Chief Medical Officer. We are encouraged by the continued momentum in TRIDENT-1 with enrollment targets achieved in cohorts EXP-1, EXP-4 and EXP-6. We look forward to continuing to progress repotrectinib toward registration with our first pre-NDA meeting with the FDA to discuss the topline data by blinded independent central review from the ROS1-positive advanced NSCLC cohorts of the TRIDENT-1 study expected later this quarter.

BTD is granted by the FDA to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition. The criteria for BTD require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

Repotrectinib was previously granted two BTDs in: ROS1-positive metastatic NSCLC patients who have not been treated with a ROS1 tyrosine kinase inhibitor, and patients with advanced solid tumors that have an NTRK gene fusion who have progressed following treatment with one or two prior TRK tyrosine kinase inhibitors, with or without prior chemotherapy, and have no satisfactory alternative treatments. Repotrectinib was also previously granted four Fast-Track designations in: ROS1-positive advanced NSCLC patients who are ROS1 TKI nave; ROS1-positive advanced NSCLC patients who have been previously treated with one prior line of platinum-based chemotherapy and one prior ROS1 TKI; ROS1-positive advanced NSCLC patients pretreated with one prior ROS1 TKI without prior platinum-based chemotherapy; and NTRK-positive patients with advanced solid tumors who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK TKIs and have no satisfactory alternative treatments. Repotrectinib was also granted an Orphan Drug designation in 2017.

Story continues

Enrollment across all six cohorts of the study remains open and continues to progress steadily.

About Turning Point Therapeutics Inc.Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of investigational drugs designed to address key limitations of existing cancer therapies. The companys lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is being studied in a registrational Phase 2 study in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-nave and pre-treated patients. The companys pipeline of drug candidates also includes elzovantinib, targeting MET, CSF1R and SRC, which is being studied in a Phase 1 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in MET; TPX-0046, targeting RET, which is being studied in a Phase 1/2 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in RET; TPX-0131, a next-generation ALK inhibitor, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer; and TPX-4589 (LM-302), a novel ADC targeting Claudin18.2 being studied in a Phase 1 study in gastrointestinal cancers. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit http://www.tptherapeutics.com.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the momentum in TRIDENT-1 study, the ability to continue to progress repotrectinib toward registration, timing of Turning Point Therapeutics first pre-NDA meeting with the FDA to discuss the topline data by blinded independent central review from the ROS1-positive advanced NSCLC cohorts of the TRIDENT-1 study, the potential benefits of BTD, progression of enrollment, and the efficacy and therapeutic potential of repotrectinib. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as plans, will, believes, anticipates, expects, intends, goal, potential and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Turning Point Therapeutics current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics business in general, risks and uncertainties related to the impact of the COVID-19 pandemic to Turning Points business and the other risks described in Turning Point Therapeutics filings with the Securities and Exchange Commission (SEC), including its annual report on Form 10-K filed with the SEC on February 28, 2022. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contact: Adam D. Levy, PhD, MBAir@tptherapeutics.com858-867-6366

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Turning Point Therapeutics Granted Breakthrough Therapy Designation for Repotrectinib Treatment in Patients With One Prior ROS1 Tyrosine Kinase...

Missing a dose or two of diabetes or hypertension medicationmay not seem like a big deal to many people. There are some who even skip it deliberately for several days because it causes no obvious problems -- when they have no symptom/ trouble without the pills, or start taking alternative medicine. General physicians are all too familiar with such cases.

Internal Medicine specialist Hemanth Kalakuntla said he has come across some patients with those non-communicable diseases (NCDs), who skip the medicines and try to trick doctors during consultations. People with diabetes have to get their fasting and post-lunch blood glucose levels checked through tests before consulting a doctor. Some, who stop taking medicines, skip lunch and undergo post-lunch test so that their blood glucose levels does not reflect as being abnormally high. But we have our own ways to detect their situation, he added.

Not sticking to medications for diabetes and hypertension, he said, could cause damage to eyes, kidneys, and worse, lead to brain stroke or heart attack.

Head of Critical Care department at Government Medical College, Nizamabad, Kiran Madhala and his team attend patients in ICUs. Some reasons that patients with the NCDs suffered from severe complications were that they did get their medicines dosage corrected, or did not make lifestyle changes, thereby worsening their condition.

Some of the patients were just not aware that they had hypertension or diabetes, said Dr Kiran, adding that everyone above the age of 30 years should get screened for the NCDs.

Assistant Professor of General Medicine at Osmania General Hospital, Pratibha Lakshmi said a significant per cent of emergency visits to hospitals are by people who stopped taking medicines for various diseases. This is observed in diseases which require long-term compliance to medicines. Some of the diseases are diabetes, hypertension, tuberculosis, HIV, or diseases related to the heart or kidneys, she explained.

When people stop taking medicines, they may suffer form health issues which is likely to necessitate complicated treatment, even surgery. Dr Pratibha said all of that could mean damage to health which brings down quality of life, and spending more money, which ultimately burden the patient and the family.The burden on healthcare increases too, she pointed out.

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Skipping medication a perilous habit, warn doctors - The Hindu

DGC Naturopathy

Published: Mon 9 May 2022, 3:12 PM

Over the past years, modern medicine has helped in reducing the mortality rate significantly. However, the excessive usage of medicines has also led to serious side effects on human bodies and lacks emphasis on preventing non-communicable diseases. Hence, an integrated and preventive approach through Naturopathy that seeks to restore and maintain optimum health by emphasizing natures inherent self-healing process can help reduce the burden of disease and lessen healthcare costs.

Encouraging such a holistic approach for the prevention and treatment of diseases, DGC Naturopathy Heart & Cancer Care center has emerged as one of the leading healthcare naturopathy centers, specializing in the treatment of various forms of cancer and other illnesses.

Established by Dr. Dilip Damodar Donekar, DGC Naturopathy Heart & Cancer Care center has contributed to the expansion of holistic medical care by offering comprehensive wellness therapy through Naturopathic treatment. He runs two Naturopathy centers in Maharashtra (Nagpur & Mumbai) which are dedicated for the treatment of chronic and complicated diseases using natural remedies to help the body heal itself. Having completed his Ph.D. in Naturopathy in the USA, he specializes in the treatment of various forms of cancer and also offers treatments for psoriasis, epilepsy, paralysis, migraine, joint pain, jaundice, chronic diseases, asthma, allergy, diabetes, kidney stone, blood pressure, HIV as well as for different problems related to ones skin. He also treats female health issues and offers yoga and meditation sessions for stress relief, healthy living, and spiritual upliftment.

Since Naturopathy considers food and the natural environment as its medicine it is seen as the most natural and non-invasive methodology of alternative medicine that leads to self-healing. A good and sustainable lifestyle encompasses physical and emotional well-being. Todays polluted environment, adulterated food, poor diet, stressful and hectic lifestyles impede ones ability to stay healthy. The Naturopathy philosophy is based on the principle that nature can treat people and help the body to heal itself, says Dr. Donekar. He believes in enhancing the immunity of a body and has developed special treatment protocols and innovative herbal medicines which have given a disease-free life to many, as shared through the success stories and testimonies of his patients.

Listed in Forbes India as one of the best Naturopathic cancer doctors, he is a recognized specialist who uses the principle of Naturopathy for the treatment of patients which has earned him popularity not just in India, but also in many parts of the world such as the UK, USA, UAE, Australia, etc. His practice focuses primarily on any form of cancer, enabling him to work with other researchers in the field towards the development of anti-cancer drug medicine and therapies. He has patients visiting him for consultations from some of the top and well-known hospitals in the country for cancer as well as heart diseases.

He has received several national and international awards from various government dignitaries such as Ashwini Kumar Choubey (Minister of State for Health and Family Welfare), Dr. J K Singh- President of Cancer Care of India- IMA, Nitin Gadkari (Minister for Road Transport & Highways), Bhagat Singh Koshyari (Governor of Maharashtra), Uddhav Thackeray (Chief Minister of Maharashtra), Sudhir Mungantiwar (MLA), Nana Patole (MLA); Bollywood celebrities like Poonam Dhillon, Malaika Arora, Zeenat Aman, Parineeti Chopra as well as from ace sportsman such as Chetan Sharma and Kiran More for his contribution to the world of Naturopathy earning him the popularity of being one of the best naturopathic and cancer care doctors in a short span of time. He has also been recognized as one of the ten influential leaders in the field of alternative medicine in 2021. He is also the recipient of the

CSR Journal Excellence Awards for his contributions toward social welfare and growth through Naturopathy. His work has also received prominence through his publication titled Lockdown- The Nature of Naturopathy (2021), launched by Maharashtra Cabinet Minister Shri Anil Deshmukh.

With a vision to make Naturopathy accessible, he has recently established a new center in Dubai with an objective to partner with the Health Ministry of the country and create awareness about Naturopathy. His contributions to Naturopathy have also received immense appreciation in the Asia Book of Records (2018) organized by the International Naturopathy Organisation (INO) in association with the Ministry of Ayush, Government of India. He holds the India book of Records (2018) for conducting a mass mud bath organized by the International Naturopathy Organisation (INO) in association with the Ministry of Ayush, Government of India.

To know more about him and to get in touch with Dr. Donekar, please visit:

https://en.bharatpedia.org.in/wiki/Dilip_Damodar_Donekar and http://www.naturopathydoctor.in/

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Transforming healthcare through Naturopathy - wknd.

Republican J.D. Vance wins Ohio primary after Donald Trump endorsement

Trump's pick for the Ohio GOP candidate, J.D. Vance, wins a spot in the November Senatorial election.

Cody Godwin, USA TODAY

In the Ohio Senate race, former PresidentDonald Trumps endorsement lifted a media personality and outsider candidate to the GOP nomination over a crammed Republican field.

Now, Mehmet Oz, better known as Dr. Oz, hopes thatTrumps influence will come to bear in Pennsylvanias Republican Senate primary, where he holds a thinlead in the polls, according to RealClearPolitics.

Trumpendorsed Oz last monthin his bid to replace retiring Republican Sen. Pat Toomey.

Ozs celebrity status has made him the subject of intense scrutiny by his opponents, who have questioned his loyalty to the country because he holds dual U.S. and Turkish citizenship.

Aside from Oz, the main contendersin the Republican primary are Dave McCormick, a former hedge fund manager, and conservative political commentator Kathy Barnette.

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Oz is best known for his nationally syndicated television program the Dr. Oz Show, which came to an end with his Senate run. Ozs ascent to fame began with frequent appearances on the Oprah Winfrey show, where he appeared as a health expert,before finally getting his own show in 2009.

He had worked as a heart surgeon at the New York Presbyterian Hospital, according to his biography on the Dr. Oz Show website.

In the medical community, Ozs promotion of alternative medicines has made him a controversial figure. Some doctors have gone as far as to publicly call for Columbia University, where Oz taught, to cut its ties with the now Senate candidate, Vox reported.

The university removed Ozs profile from its website, the Daily Beast and others reported, following his Senate race entrance.

Oz earned his doctor of medicine from the University of Pennsylvaniain 1986. He also has an undergraduate degree from Harvard University and a Master ofBusiness Administration from the University of Pennsylvanias Wharton School.

Oz'sparents immigrated to the U.S. from Turkey. His father, Mustafa, had also been a surgeon.

Oz was born on June 11, 1960 in Cleveland, Ohio. He is 61 years old.

Ozs campaign website lists more than a dozen issue areas. In his first campaign ad, Oz appealed to his medical background and addressed the COVID-19 pandemic.

They took away our freedom, Oz said in the ad. Without making us safer.

His campaign site notes Ozs opposition to business shutdowns and support for keeping children in schools. He also told Fox News he was opposed to vaccine mandates.

Another focus of the Oz campaign is energy independence, which was one of manyissues highlighted in Trumps endorsement statement. Hiscampaign site says Oz supports slashing regulations on the fossil fuel industry to increase domestic energy production.

The rest of Ozs platform runs the gamut on the GOP's defining issues during Joe Biden's presidency.

Election security, cancel culture, and get tough on China, are all focuses of the campaign along with more classic Republican positions ongun rights, the economy,immigration and abortions.

On Twitter, Oz weighed in on the leaked majority opinion draft written by Supreme Court Associate Justice Samuel Alito, agreeing with Alitos rebuke of Roe v. Wade.

Aside from Trump, Oz is backed by former RepublicanTexas governor Rick Perry and Fox News Sean Hannity. J.D. Vance, theOhio GOP Senate nominee, and former Republican presidential candidate and Housing and Urban Developmentecretary Ben Carson also support Oz.

One of Ozs children is his daughter Daphne Oz, a chef and TV personality, who hosts a cooking show that replaced her fathers show. In 1985, Oz married his wife Lisa, with whom he has four children.

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Trump is backing 'Dr. Oz' in the Pennsylvania Senate race. What to know about the ex-TV show host - USA TODAY

The captive breeding of lions to meet the rising demand for alternative medicine and ornamental industries should be halted in order to save the majestic carnivore that roams African jungles, lobby groups said on Wednesday.

The World Animal Protection and Blood Lions said in a joint statement issued in Nairobi, the Kenyan capital, that cruelty meted out on lions in captivity was a reason to halt the practice and allow them to roam freely in their natural habitats.

Edith Kabesiime, the wildlife campaigns manager at World Animal Protection said that legislation should be enacted to ban caging of lions on commercial farms amid threat to their physical and emotional health.

According to Kabesiime, the survival and welfare of lions and other iconic carnivores in Africa was in jeopardy amid caged rearing, trophy hunting and habitat loss.

She urged African governments to support community-driven conservation of lions as opposed to captive breeding that was fueling the spread of pathogens.

Kabesiime lauded South Africa in its pledge to phase out captive breeding of lions adding that a ban on trade in their parts including bones could aid efforts to boost their population in the wild.

A joint study by World Animal Protection and Blood Lions, an advocacy group, that was published in early May noted that breeding lions in a captive environment undermined their health and comfort.

Based on data collected from South Africa's commercial lion farms, the study concluded that captive breeding contravened global best practices on protecting the carnivores from human-induced and climatic threats.

"It is clear from review of scientific literature available that a multitude of animal welfare challenges are associated with caring for lions in captivity," said the study.

Louise de Waal, the director of Blood Lions said that captive breeding, poaching, habitat loss and fragmentation posed an immense threat to the survival of the big cats despite their contribution to tourism and ecological balance. Enditem

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African lobbies call for end to captive breeding of lions as threats intensify - China.org.cn

What risks would you take if you were only able to function for one, maybe two hours a day? The rest of the day, you must lie down with an eye mask on while listening to something quiet. You can't work, exercise or drive. You can't leave the house for more than an hour or two once a week.

Would you risk an increased chance of skin cancer? Or possible vision damage and blindness?

I would. I am.

Many years ago, I woke up one morning unable to move my body from my bed. It felt like a tonne of wet cement had been poured on top of me and I couldn't shift it. I struggled to answer questions, read, remember things and connect ideas. Getting myself up or out of the house to work became an extreme sport.

After eight years visiting doctor after doctor, I was diagnosed with a disease known as Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME).

ME has no treatment or cure. Millions of people are joining this cohort via long COVID, which shares striking similarities with ME. Both patients and doctors are in a murky world of unknowns.

But I am one of the lucky ones: I've become a human experiment.

If there's a chance a treatment could increase my capacity so I can work, or drive, or socialise independently again, I will try it. When you're trapped with a debilitating illness, any different feeling can be a welcome relief.

I experiment with different medications under the guidance of trusted medical professionals. As I see it, medication is technology. Why wouldn't I use technology to try and improve my quality of life? That's not to say it's a simple or easy process.

For years, I was shunted between different doctors for extensive, expensive tests. They couldn't find anything that medicine had a treatment for. I tried lifestyle changes and alternative therapies to no avail. Finally, I decided it was time to experiment.

I was referred to a specialist with an interest in ME and, when I asked him whether there was anything we could try to "improve my capacity", he was up for the challenge. Each appointment, we discuss different medications we have heard of in the ME space (all are designed to treat other illnesses). Together, we weigh their potential risks and benefits.

My specialist reviews my bloods and decides whether a particular medication is appropriate for me to trial and at what dosage. Each time he says: "We have no idea what will happen and there are no guarantees", and I ask about potential side effects to monitor for and hazards to avoid. We discuss how expensive the medication is and where I can find it. Then we monitor my body's response.

This morning, I took nine pills. Three of them are "private non-PBS prescription", which means they are expensive and untested for treating my illness. Four of the pills slightly increase my brain function to the extent that I wouldn't be able to write this without them but neither my doctor or I know why.

Some medication trials have been ineffective. One drug caused my vision to blur so I couldn't see or read. My specialist at the time advised me to "wait it out" but I decided to pull the pin. Years later, the same medication would end up helping me, I just have to get regular eye tests.

Some of the medication has suppressed my immune system and made me vulnerable to dangerous viruses. Some have caused headaches, gut infections, skin infections, staph infections, anxiety, mood swings, drenching night sweats, constipation, diarrhoea, vertigo, twitching, itching... the list goes on. Many of the medications cause nausea. Sometimes it's manageable, sometimes it's miserable.

These technologies have a way to go. But on my current regime, I can get up and shower (with my shower seat) most days. Sometimes I can write. If I have notice for a big event with loved ones, I can socialise and recover. For me, these are life changing gains.

In an ideal world, though, these medications would be properly tested in controlled studies rather than on very sick people.

Some disabilities are "over medicalised". Disabilities are often seen as medical problems when many really arise from a lack of accessibility. As Dylan Alcott recently explained, when he is in an accessible space, he is not disabled. It is inaccessible spaces that disable him. This is the social model of disability.

Inaccessibility disables me, too stairs and lack of seating or rest areas limit my capacity to move through the world and participate in society. But I am also disabled by a lack of medical attention, research and funding for my disease. In my experience, the thing that most disables people with energy limiting chronic illnesses like ME and long COVID is that governments, medical funding bodies and scientific research communities do not see the problem.

Perhaps one of the reasons for this lack of focus and funding is because most ME patients are women. Diseases predominantly affecting women receive significantly less research funding. This means women and gender diverse people's bodies are still poorly understood in medicine.

Shockingly, female animals and humans were excluded from medical testing until very recently. Women have been prescribed drugs for decades without them having been tested on female bodies.

This lack of knowledge is compounded by the incentive for doctors to provide short consults, limiting the potential for women's complex illnesses to be properly treated. Together, these factors result in doctors too often distrusting women and gender diverse people's accounts of their own bodies.

Millions of people globally, up to 80 per cent of them women, present to doctors with the debilitating symptoms of ME. Some doctors tell us to rest or lose weight or see a psychologist. An infectious diseases specialist smiled at me indulgently and suggested I was "just tired" because of my work as a lawyer. One senior immunologist said I would "probably" get better because I was not obese and had a positive attitude; there was "no need" for a further appointment.

Both were wrong because ME is a complex neuro-immune disease. I haven't worked as a lawyer since 2014 and though my optimism has survived, so too has my disease.

Funding is urgently needed for research into ME so that one day when I, and millions of others, go to the doctor, they are not only able tell me what's wrong, but how they can treat it. Instead of saying "we don't know what will happen", they can say "this should give you some relief".

For more information about ME click here. To support homegrown research into ME check out the National Centre for Neuroimmunology and Emerging Diseases at Griffith University.

Alice Rumble is a disabled writer and advocate living with ME. She shares her stories of disability on Instagram at @alice_rumble.

Posted13 May 202213 May 2022Fri 13 May 2022 at 7:00pm, updated13 May 202213 May 2022Fri 13 May 2022 at 10:32pm

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I'm one of thousands of Australians with chronic fatigue syndrome but I'm lucky: I've become a human experiment - ABC News

The treatment landscape continues to expand across nonsmall cell lung cancer (NSCLC), with the FDA approvals of multiple agents, including targeted therapies such as sotorasib (Lumakras) and lorlatinib (Lorbrena), according to faculty from an OncLive State of the Science Summit on lung cancer.

The event, chaired by Christine Bestvina, MD, assistant professor of medicine, hematology and oncology (cancer), University of Chicago Medicine Comprehensive Cancer Center, highlighted updates across the lung cancer landscape, including the use of frontline immunotherapy in NSCLC, plus the role CTLA-4 inhibitors could play in this patient population.

Bestvina was joined by her colleagues:

Below, Fidler, Weinberg, Bestvina, Feldman, and Vokes summarize the main messages from their presentations.

Fidler: Comprehensive next-generation sequencing [NGS] is essential for [patients with] stage IV adenocarcinoma. [NGS] should include RNA sequencing and circulating tumor DNA [ctDNA] assays, [which] can maximally capture targeted alterations. We saw that with a [2018 report by Charu Aggarwal, MD, MPH, of Penn Medicine,] where some of the alterations were only captured in the ctDNA assays.

Perioperative PD-L1 [testing] could be useful to guide multimodality therapy, and EGFR testing should be performed on resectable patients that may pursue a neoadjuvant chemotherapy [plus] immunotherapy approach, given the overwhelming disease-free survival benefit with osimertinib [Tagrisso] for [patients with EGFR mutations].

Weinberg: Sotorasib received [FDA] approval in May 2021 for patients with KRAS G12C[mutated] metastatic NSCLC in the second-line setting or later. Adagrasib is a KRAS G12C inhibitor, but it is not yet approved.

In general, [KRAS G12C inhibitors] are tolerated well. Gastrointestinal [adverse] effects [AEs] and liver abnormalities are the largest treatment-related AEs. There is emerging data in studies that we should keep an eye on in terms of combination treatment thats ongoing.

Lorlatinib was approved in March 2021 for the treatment of patients with ALK fusionpositive metastatic NSCLC. Alectinib [Alecensa], for most [clinicians], is still our go-to first-line [treatment] for patients with ALK fusionpositive metastatic NSCLC. But I would consider lorlatinib in the first line if the patient has significant central nervous system metastasis. [It is important to] be aware of the unique [AE] profile of lorlatinib.

Selpercatinib [Retevmo] was FDA approved in May 2020 [for the treatment of patients with RET alterationpositive NSCLC]. Pralsetinib [Gavreto] was approved in September 2020 for the first-line treatment of patients with metastatic NSCLC with RET fusions. [Notably], selpercatinib has less myelosuppressive [AEs].

Larotrectinib [Vitrakvi] was approved in November 2018 [for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment]. Entrectinib [Rozlytrek] was approved in August 2019 for the first-line treatment of solid tumors harboring NTRK fusions without resistance mutations. [Additionally], there are emerging second-generation inhibitors to overcome on-target resistance.

Bestvina: Immune monotherapy is whats preferred for patients [with NSCLC] who have high PD-L1 [expression], although chemotherapy [plus] immunotherapy may be preferred in never smokers or patient [who present with more aggressive disease]. Chemotherapy [plus] immunotherapy is whats recommended to for [patients with] a [PD-L1 tumor proportion score of] less than 50%.

The addition of a CTLA-4 [inhibitor] may be helpful for certain patient subgroups. But stay tuned, because lots of combination trials [are expected] to read out soon.

Feldman: In the paradigm of treatment for extensive-stage SCLC, we want to consider clinical trials. In the first-line setting, [treatment options include] etoposide [and] platinum [chemotherapy combined with] either atezolizumab [Tecentriq] or durvalumab [Imfinzi]. In the second-line setting, we have an FDA approval for topotecan and lurbinectedin [Zepzelca]. Many investigators prefer [liposomal] irinotecan instead of topotecan, although that is an off-label usage.

In the third-line setting for patients who havent had a checkpoint inhibitor, one can consider pembrolizumab [Keytruda] or nivolumab [Opdivo]. Otherwise, we still have agents such as paclitaxel and temozolomide [Temodar] to consider in the third-line setting.

Vokes: Survival [rates] in resectable lung cancer are still too low. Although we should be happy with the [current] results, we shouldnt be content and say we dont have to look any further. Targeted therapies and immune checkpoint inhibitors have significantly improved treatment outcomes, and resection is the key. [Treatment can be given before or after surgery], but the key is to cut [the disease] out, [if possible].

[The use of] adjuvant and neoadjuvant chemotherapies are evidence based. Osimertinib is [FDA] approved [as an adjuvant treatment following tumor resection in EGFR-mutated NSCLC], and atezolizumab [is approved for use as an adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA NSCLC with a PD-L1 expression on 1% or moreof tumor cells]. Moreover, neoadjuvant nivolumab and [platinum-doublet chemotherapy was recently approved for adult patients with resectable NSCLC].

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Targeted Therapies Continue to Expand the Treatment Paradigm in NSCLC - OncLive

A nationwide baby formula shortage is causing frustration and fear for parents in the country.

Over 40 percent of formula is currently out of stock across the country, according to Datasembly. This is due to the closure of a major formula production plant back in February, which was only made worse by pandemic-related supply chain issues.

And while the plant has announced its plans to reopen in the coming weeks, the reality is that parents are still at least a month away from being able to find their preferred formulas back on the shelves.

What do you need to know about this formula shortage, and what can you do to make sure your child is receiving the proper nutrients in the interim? We spoke with experts to find out.

The issue behind the formula shortage is two-fold. First is the widespread supply chain issue due to the pandemic, which has affected everything from cars to Nutella.

To make matters worse, in February, the Food & Drug Administration closed Abbott Nutritions Michigan factory after Abbott voluntarily recalled brands of its formula. The formula was tied to a bacterial infection that was linked to the deaths of at least two infants.

Abbott produces Similac, a routine milk-based formula, as well as Similac Advance and other specialty formulas for babies with certain allergies.

The Biden administration has said that they are talking with suppliers in an effort to get more formula on store shelves.

This has led to parents struggling to find appropriate formulas for their kids. They are traveling out of their geographic areas and ordering products online, where not everything meets the same standards as formulas produced in the U.S., said Dr. Matthew Harris, who practices in pediatric emergency medicine, emergency medical services, and pediatrics at Northwell Healths Cohen Childrens Medical Center in New York.

Rebecca Romero, RD, LD, CLC, on the clinical nutrition and lactation team at Nationwide Childrens Hospital in Ohio, said parents are having difficulty getting enough formula to feed their children.

Due to the infant formula shortage, parents are facing the very serious problem of not having enough formula available to feed their children, added Romero. Many stores are having supply issues and parents are being forced to drive store to store to find their childs formula. Additionally, we are seeing an increase in families preparing homemade formula or mixing foods not intended for infants with formula, which can be very risky and compromise the developing infants health.

If your child uses a standard, milk-based powdered formula, several alternatives are available besides Abbotts recalled formulas.

For children taking a specific formula, such as one for a milk protein allergy, experts recommend looking for a similar, alternative formula for what their child is currently taking.

It is important to select a FDA-approved formula, meaning it meets safety standards and is specifically designed to provide appropriate nutrition for infants. If parents are unsure of what product would be considered a safe alternative, they should talk to their childs healthcare provider or dietitian for guidance, said Romero.

Harris noted that other companies, like Enfamil, for example, or other U.S.-produced milk-based formulas have very little difference and would be considered safe to use as an alternative.

As a father of an infant who has a milk protein allergy, which is very common, they cannot take standard formulas, which are all increasingly difficult to find in powdered form, he said. We have been successful finding liquid formulas on Amazon; however, these liquid-based formulas can be more expensive for families facing financial distress.

Right now, parents can also look at ordering online from known entities, like Amazon, Walmart, and CVS.

While this is incredibly stressful for parents as they try to provide appropriate nutrition for their children, experts stress that parents should avoid diluting formula or ordering products from unknown online retailers.

What we want to avoid is parents extending the life of the powder formula by adding water and diluting it, said Harris. That is not good for children because it causes low sodium, and that can lead to seizures, which can be life-threatening. Never dilute formula, hard stop.

Another tip is to not order formulas from websites that may not deliver products certified in the United States. Formulas produced in the U.S. that use a typical 20 calorie-per-ounce, milk-based formula have very little difference from each other.

Harris also recommends double checking any Similac product that parents do happen to find to make sure its not part of the recall.

There are still products on the shelves that are part of the recall that may not have been taken down, he said.

The FDA has also issued warnings against using homemade formula since it isnt regulated and can be contaminated or lack key nutrients.

In a 2021 warning, the FDA said some infants fed homemade formula were hospitalized due to low calcium.

These problems are very serious, and the consequences range from severe nutritional imbalances to foodborne illnesses, both of which can be life-threatening, the FDA said in the 2021 warning.

If parents do happen to find Similac, Alimentum, and EleCare powdered infant formula products, here is what they can check to ensure it is not recalled:

In addition, Abbott Nutrition has recalled Similac PM 60/40 with a lot code of 27032K80 (can) / 27032K800 (case). Parents can also enter the product lot code on the companys website to check.

As healthcare providers, we are aware of the severity of this shortage and how it is impacting families, said Romero. Providers are working closely with families daily to help provide support and guidance to ensure their children are receiving appropriate and adequate formula. Families should make sure to talk to their childs healthcare provider or dietitian if guidance is needed.

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Infant Formula Shortage: Why it's Happening and What Parents Can Do - Healthline