Dive Brief:

Three years on from Kymriah's pioneering approval as the first CAR-T cell treatment, the drug remains a relatively niche product, used for leukemia and lymphoma patients whose cancers have resisted other treatments.

But Novartis, as well as its CAR-T competitor Gilead, have continued to study their therapies in new cancer types as well as in earlier lines of treatment.

Gilead, which sells Yescarta for diffuse large B-cell lymphoma, recently won U.S. approval for Tecartus, a slightly different version of Yescarta that is now cleared for treating patients with mantle cell lymphoma.

Sales of both Yescarta and Kymriah have grown steadily, although neither is yet the blockbuster product their respective makers made them out to be when they were approved.

Ned Pagliarulo / BioPharma Dive, sales data from companies

CAR-T therapies have shown dramatic effectiveness in some patients with few other options. But the treatments are difficult to manufacture, requiring the genetic engineering of immune cells extracted from each patient. Manufacturing is done at several sites scattered throughout the U.S. and Europe, meaning cells must be carefully frozen and shipped from treating hospitals to company plants and back.

Remarkably, neither Novartis nor Gilead have missed a delivery of their respective CAR-T treatments due to the COVID-19 pandemic, according to recent executive comments on earnings calls.

Novartis, which has struggled to produce Kymriah at the correct commercial specifications, has had its manufacturing task made easier by the recent regulatory clearances of factories in Switzerland and France.

The Swiss company plans to submit data from the ELARA trial to the Food and Drug Administration and the European Medicines Agency in 2021. Detailed results will be shared at an upcoming medical meeting, likely the American Society of Hematology's now virtual conference in December.

After diffuse large B-cell, follicular lymphoma is the second most common type of non-Hodgkin lymphoma. Recent approved treatments include Verastem Oncology's Copiktra and Bayer's Aliqopa.

Link:

Novartis says CAR-T cancer therapy works in second lymphoma type - BioPharma Dive