Bristol-Myers Squibb Company BMY announced that the FDA has accepted its Biologics License Application (BLA) for pipeline candidate lisocabtagene maraleucel (liso-cel) and granted Priority Review.
The company is seeking approval of lisocabtagene maraleucel (liso-cel), its autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells, for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies.
The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of Aug 17, 2020.
The Priority Review designation from the FDA is generally granted to drugs that would bring significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
The BLA was submitted by Bristol-Myers’ subsidiary, Juno Therapeutics.
It was based on the safety and efficacy results from the TRANSCEND NHL 001 study, evaluating liso-cel in 268 patients with R/R large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade lymphoma, primary mediastinal B-cell lymphoma and Grade 3B follicular lymphoma.
A tentative approval of the candidate will boost Bristol-Myers’ portfolio and revenues.
The candidate was previously granted Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations by the FDA for R/R aggressive large B-cell non-Hodgkin lymphoma, including DLBCL, not otherwise specified (de novo or transformed from indolent lymphoma) and PMBCL or Grade 3B FL, and Priority Medicines (PRIME) scheme by the European Medicines Agency for R/R DLBCL.
However, competition is stiff in this space from the likes of Novartis’ NVS Kymriah and Gilead Sciences, Inc. GILD Yescarta.
Bristol-Myers’ shares have rallied 30% in the past year compared with the industry’s growth of 10.6%.
The company recently reported encouraging results for the fourth quarter. Earnings and sales beat estimates primarily on the addition of Celgene’s drugs to its portfolio. However, sluggish Opdivo sales are a concern. The drug faces stiff competition from Merck’s MRK Keytruda and Roche’s Tecentriq.
Bristol-Myers 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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