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Bristol Myers (BMY) Gets FDA Approval for CAR T-Cell Therapy

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Bristol Myers Squibb (BMY - Free Report) announced that the FDA has approved its CD19-directed chimeric antigen receptor (CAR) T cell therapy, Breyanzi (lisocabtagene maraleucel; liso-cel).

The therapy is approved for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (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.

This new promising immunotherapy involves using a patient’s own immune cells to attack cancer cells. The candidate was added to the company’s portfolio with the acquisition of Celgene Corporation.

The FDA approval of Breyanzi was based on data from the TRANSCEND NHL 001 (017001) study, in which 268 patients with R/R LBCL received Breyanzi. In the study, the therapy demonstrated a 73% overall response rate and a 54% complete response (CR) rate. Breyanzi demonstrated sustained responses in patients who achieved a CR with a median duration of response not reached.

It has been granted the Priority Medicines (PRIME) designation for R/R DLBCL in the European Union and a Marketing Authorization Application (MAA) is currently under review with the European Medicines Agency.

While this innovative space promises potential, competition is stiff from the likes of Novartis’ (NVS - Free Report) Kymriah and Gilead’s (GILD - Free Report) Yescarta.

Meanwhile, approval of new drugs will add a new stream of revenues for Bristol Myers, which should propel growth in the coming quarters.

The company’s shares have lost 9.2% in the past year against  the industry's growth of 14.1%.


It recently reported better-than-expected results for the fourth quarter of 2020, as multiple myeloma (MM) drug, Revlimid, and blood thinner drug, Eliquis, drove growth for the company. Another MM drug, Pomalyst, also drove the upside. Opdivo too returned to growth after declining in the third quarter amid stiff competition from Merck’s (MRK - Free Report) Keytruda.

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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