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Gilead Submits sBLA to FDA for CAR-T in Non-Hodgkin Lymphomas

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Gilead Sciences, Inc.’s (GILD - Free Report) subsidiary, Kite, announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA for Yescarta (axicabtagene ciloleucel) for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma after two or more prior lines of systemic therapy. Follicular lymphoma and marginal zone lymphoma are both forms of indolent non-Hodgkin lymphoma (NHL) in which malignant tumors slowly grow but can become more aggressive over time.

Yescarta was previously granted Breakthrough Therapy Designation by the FDA for these indications. The submission was supported by data from the ZUMA-5 study. 

Shares of Gilead have increased 1.6% year to date against the industry’s decline of 2.3%.

ZUMA-5, is a global, multicenter, single-arm, open-label phase II study evaluating Yescarta in adults with relapsed or refractory indolent (slow growing) non-Hodgkin lymphoma (NHL) after at least two prior lines of therapy. An interim analysis of the study presented in June 2020 showed that 93% of patients (n=96 evaluable for efficacy) responded, with 80% achieving a complete response as assessed by an independent review committee after a single infusion of Yescarta.

If approved, Yescarta would become the first chimeric antigen receptor (CAR) T cell therapy approved for the treatment of relapsed or refractory indolent NHL.

Yescarta was the first CAR T cell therapy to be 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, and high-grade B-cell lymphoma and DLBCL arising from FL. 

Label expansion of the drug will boost sales for the company.

Zacks Rank & Other Stocks to Consider

Gilead currently carries a Zacks Rank #3 (Hold).

Some other better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. (EBS - Free Report) , Bio Techne Corp (TECH - Free Report) and Alimera Sciences Inc. (ALIM - Free Report) . While Emergent and Bio Techne sport a Zacks Rank #1, Alimera carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Emergent’s earnings estimates have increased from $3.45 to $6.32 for 2020 and from $4.31 to $7.01 for 2021 over the past 60 days. Shares of the company have increased 94.2% year to date.

Bio Techne’s earnings estimates have increased from $5.33 to $5.58 for 2020 and from $6.41 to $6.45 for 2021 over the past 60 days. Shares of the company have increased 12.1% year to date.

Alimera’s loss per share estimates have narrowed from $2.33 to $1.31 for 2020 and from 63 cents to 52 cents for 2021 over the past 60 days. Shares of the company have decreased 24.1% year to date.

 

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