Gilead Sciences, Inc.’s GILD Kite announced that the FDA has granted accelerated approval to its chimeric antigen receptor (CAR) T-cell therapy, Yescarta (axicabtagene ciloleucel), for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
The approval makes Yescarta the first CAR T-cell therapy approved for patients with indolent FL.
The approval was based on results from ZUMA-5, a single-arm, open-label study, in which 91% of patients with relapsed or refractory FL (n=81) responded to Yescarta, including an estimated 74% of patients in a continued remission at 18 months (Kaplan-Meier estimate). Among all FL patients, the median duration of response was not reached at a median follow-up of 14.5 months.
We note that Yescarta is already approved for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from FL.
The approval will strengthen Gilead’s CAR T cell therapy franchise.
Another CAR T cell therapy, Tecartus, in the company’s portfolio, is approved for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
The approval of other indications for these therapies will boost the franchise, which recorded sales of $607 million in 2020, up 33%. However, competition is stiff from the likes of Novartis’ NVS Kymriah.
Gilead’s stock has gained 11% in the year so far compared with the industry's decline of 1.7%.
The massive decline in sales of its HCV franchise has prompted it to focus on the HIV franchise, Yescarta and other newer avenues.
The FDA recently approved Bristol-Myers’ BMY Breyanzi, a CAR T cell therapy for certain types of non-Hodgkin lymphoma, DLBCL.
Other players in this evolving innovative field of CAR T cell therapies include Allogene Therapeutics, Inc. ALLO, among others.
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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