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Gilead's BLA for CAR T Cell Therapy Gets FDA Acceptance

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Gilead Sciences, Inc. 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 GSK.

Gilead’s stock has gained 5.5% in the past year against the industry's decline of 2.2%.

However, the uptake of Yescarta has not been per expectations, given the exorbitant cost and competition from Novartis’ (NVS - Free Report) Kymriah. Gilead has also collaborated with Kiniksa Pharmaceuticals, Ltd. KNSA to conduct a phase II, multicenter study of mavrilimumab, which is an investigational, fully-human monoclonal antibody that targets granulocyte macrophage colony-stimulating factor receptor alpha, in combination with Yescarta in patients with relapsed or refractory large B-cell lymphoma. Gilead’s intention to foray into the inflammation market to diversify the revenue base is encouraging as well.

Gilead currently carries a Zacks Rank #5 (Strong Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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