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Bristol Myers (BMY) CAR T Cell Therapy Abecma Approved by EC

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Bristol Myers (BMY - Free Report) recently announced that the European Commission (“EC”) has granted Conditional Marketing Authorization to its chimeric antigen receptor (CAR) T cell immunotherapy, Abecma.

Abecma is a first-in-class B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy. It is approved for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

We note that Conditional Marketing Authorization in the EU is initially valid for one year but can be extended or converted into a full Marketing Authorization after the submission and assessment of additional confirmatory data.  It does not include approval in Great Britain (England, Scotland and Wales).

The approval of Abecma was based on the results of the KarMMa study of patients worldwide, including five European countries, which demonstrated rapid, deep and durable responses with a well-understood and predictable safety profile.

Abecma is already approved in the United States 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.

It is being jointly developed and commercialized in the United States as part of a Co-Development, Co-Promotion, and Profit Share Agreement with bluebird bio (BLUE - Free Report) .

Approval in additional regions will boost the growth potential of the therapy and strengthen Bristol Myers’ portfolio. 

In February, Bristol Myers also obtained FDA approval for Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed CAR T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL).

Shares of the company have gained 10.4% year to date against the industry's decline of 2.6%.

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While the CAR T space has potential, competition is stiff in the space from the likes of Gilead’s (GILD - Free Report) Yescarta and Novartis’ (NVS - Free Report) Kymriah.

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.