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Gilead's (GILD) CAR T Cell Therapy Yescarta Gets FDA Nod for FL
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Gilead Sciences, Inc.’s (GILD - Free Report) 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 - Free Report) 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 - Free Report) 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 - Free Report) , among others.
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
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Gilead's (GILD) CAR T Cell Therapy Yescarta Gets FDA Nod for FL
Gilead Sciences, Inc.’s (GILD - Free Report) 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 - Free Report) 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 - Free Report) 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 - Free Report) , 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.
Zacks Names “Single Best Pick to Double”
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
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