Gilead's BLA For CAR T Cell Therapy Gets FDA Acceptance
Zacks Investment Research | Feb 10, 2020 09:12PM ET
Gilead Sciences, Inc. (NASDAQ:GILD) announced that the FDA accepted Kite’s Biologics License Application (BLA) and granted Priority Review designation to investigational chimeric antigen receptor (CAR) T cell therapy, KTE-X19.
The company is seeking approval of KTE-X19 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
The BLA is supported by data from the single-arm, open-label, phase II ZUMA-2 study, which showed that 93% of patients responded to a single infusion of KTE-X19, including 67% of patients achieving a complete response, as assessed by an Independent Radiologic Review Committee.
The FDA has set a target action date of Aug 10, 2020.
KTE-X19 is currently in phase I/II studies, being evaluated in acute lymphoblastic leukemia (ALL), MCL and chronic lymphocytic leukemia (CLL).
Meanwhile, the European Medicines Agency (EMA) recently validated the Marketing Authorization Application for KTE-X19 in the European Union. The candidate has been granted Breakthrough Therapy Designation (BTD) by the FDA and Priority Medicines (PRIME) designation by the EMA for relapsed or refractory MCL.
A potential approval will give Gilead a second cell therapy treatment in its portfolio.
Gilead’s Yescarta was the first CAR T cell therapy approved by the FDA for the treatment of 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 follicular lymphoma.
We note that the massive decline in sales of the HCV franchise has propelled Gilead to focus on the HIV franchise, Yescarta and other newer avenues. The rapid adoption of Biktarvy propels the HIV business amid stiff competition from the likes of GlaxoSmithKline (NYSE:GSK) .
Gilead’s stock has gained 5.5% in the past year against the Original post
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