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bluebird (BLUE), Bristol Myers CAR T Cell Therapy Gets FDA Nod
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Shares of bluebird bio, Inc. (BLUE - Free Report) gained 3.2% after the company and its partner Bristol Myers Squibb (BMY - Free Report) announced that the FDA has approved their chimeric antigen receptor (CAR) T cell immunotherapy idecabtagenevicleucel under the brand name Abecma.
The regulatory agency approved Abecma as the first B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.
The immunotherapy is a personalized immune cell therapy approved as a one-time infusion with a recommended dose range of 300 to 460 x 106 CAR-positive T cells. Abecma recognizes and binds to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells.
The FDA nod was based on data from the pivotal phase II KarMMa study of 127 patients with relapsed or refractory multiple myeloma. The efficacy evaluable population consists of 100 patients who received Abecma within the dose range of 300 to 460 x 106 CAR-positive T cells. 88% of these patients received four or more prior lines of therapy while 85% was triple-class refractory. The overall response rate (ORR) for the efficacy evaluable population was 72% while 28% of patients achieved a stringent complete response.
The approval lends a significant boost to bluebird on two counts, marking its first approved treatment in oncology as well as its first approved treatment in the United States.
Shares of the company have plunged 32.9% in the year-to-date period compared with the industry’s decline of 3.6%.
For Bristol Myers, this is the second CAR T cell therapy approved after Breyanzi, which got the nod for adults with relapsed or refractory large B-cell lymphoma.
Other approved CAR T cell therapies in the United States include Gilead’s (GILD - Free Report) Yescarta and Novartis’ (NVS - Free Report) Kymriah.
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bluebird (BLUE), Bristol Myers CAR T Cell Therapy Gets FDA Nod
Shares of bluebird bio, Inc. (BLUE - Free Report) gained 3.2% after the company and its partner Bristol Myers Squibb (BMY - Free Report) announced that the FDA has approved their chimeric antigen receptor (CAR) T cell immunotherapy idecabtagenevicleucel under the brand name Abecma.
The regulatory agency approved Abecma as the first B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.
The immunotherapy is a personalized immune cell therapy approved as a one-time infusion with a recommended dose range of 300 to 460 x 106 CAR-positive T cells. Abecma recognizes and binds to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells.
The FDA nod was based on data from the pivotal phase II KarMMa study of 127 patients with relapsed or refractory multiple myeloma. The efficacy evaluable population consists of 100 patients who received Abecma within the dose range of 300 to 460 x 106 CAR-positive T cells. 88% of these patients received four or more prior lines of therapy while 85% was triple-class refractory. The overall response rate (ORR) for the efficacy evaluable population was 72% while 28% of patients achieved a stringent complete response.
The approval lends a significant boost to bluebird on two counts, marking its first approved treatment in oncology as well as its first approved treatment in the United States.
Shares of the company have plunged 32.9% in the year-to-date period compared with the industry’s decline of 3.6%.
For Bristol Myers, this is the second CAR T cell therapy approved after Breyanzi, which got the nod for adults with relapsed or refractory large B-cell lymphoma.
Other approved CAR T cell therapies in the United States include Gilead’s (GILD - Free Report) Yescarta and Novartis’ (NVS - Free Report) Kymriah.
bluebird bio currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
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