Bristol Myers' (BMY) Breyanzi sBLA Gets FDA's Priority Review

Bristol-Myers Squibb Company BMY announced that the FDA has accepted and granted priority review to its supplemental biologics license application (sBLA) seeking approval for its CD19-directed CAR-T cell therapy, Breyanzi (lisocabtagene maraleucel), for an expanded use.

The sBLA seeks approval of Breyanzi for the treatment of adult patients with relapsed or refractory large B-cell lymphoma LBCL after the failure of first-line therapy. With the FDA granting priority review to the sBLA, a decision from the regulatory body is expected on Jun 24, 2022.

The FDA approved Breyanzi in February 2021 for the treatment of adult patients with relapsed or refractory LBCL after two or more lines of systemic therapy, including diffuse large B-cell lymphoma or DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.

The above sBLA filling was based on data from the phase III TRANSFORM study that evaluated Breyanzi as a second-line treatment for relapsed or refractory LBCL versus the standard-of-care regimen of salvage chemotherapy followed by high-dose chemotherapy plus autologous hematopoietic stem cell transplant.

Data from the same showed that treatment with Breyanzi led to a clinically meaningful and statistically significant improvement in event-free survival, complete response rate and progression-free survival compared to standard of care.

Shares of Bristol Myers have rallied 11.2% in the past year against the industry’s decline of 38.8%.

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Breyanzi generated sales worth $87 million in 2021. Potential label expansion of the drug should also boost its sales in 2022 and beyond.

In March 2021, Bristol Myers and partner bluebird bio, Inc. BLUE obtained the FDA approval for Abecma (idecabtagene vicleucel) as the first B-cell maturation antigen-directed CAR-T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma.

Abecma is jointly developed and commercialized in the United States as part of a profit-sharing agreement between Bristol Myers and bluebird bio. Abecma generated sales worth $164 million in 2021.

bluebird bio records revenues from its collaboration arrangement with Bristol Myers for Abecma.

Approval of new drugs has added a new stream of revenues for Bristol Myers, which should propel growth in the future quarters.

Zacks Rank & Stocks to Consider

Bristol Myers currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Axsome Therapeutics, Inc. AXSM and Kaleido Biosciences, Inc. KLDO, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Axsome Therapeutics’ loss per share estimates have narrowed 0.8% for 2022 over the past 60 days.

Earnings of Axsome Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.

Kaleido Biosciences’ loss per share estimates have narrowed 11.3% for 2022 over the past 60 days.

Earnings of Kaleido Biosciences have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.

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