Bristol-Myers BMY announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for its experimental candidate, lisocabtagene maraleucel (liso-cel).
Liso-cel, an experimental CD19-directed chimeric antigen receptor (CAR) T cell therapy, is being evaluated for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) after at least two prior therapies.
The validation of the application confirms that the submission is complete and the EMA will begin its centralized review process.
The application was based on results from TRANSCEND NHL 001, the largest study in third-line or greater R/R large B-cell lymphoma (LBCL), and additional data from the TRANSCEND WORLD study. The studies evaluated patients with R/R LBCL and included patients with a broad range of histologies and high-risk disease as well as those who received liso-cel in the outpatient setting.
We note that the EMA previously granted liso-cel access to the PRIME scheme for the treatment of R/R DLBCL and Accelerated Assessment status, which reduces the maximum timeframe to 150 days for the EMA’s Committee for Medicinal Products for Human Use (CHMP) to review the application.
In May 2020, Bristol-Myers announced that the FDA has extended the action date for its biologics license application (BLA) for lisocabtagene maraleucel (liso-cel) by three months. The new Prescription Drug User Fee Act (PDUFA) action date set by the FDA is Nov 16, 2020. Bristol-Myers had submitted additional information upon the agency’s request, which was deemed to constitute a major amendment to the application and will require additional time for FDA review.
A tentative approval of the candidate will boost Bristol-Myers’ portfolio and revenues.
However, competition is stiff in this space from the likes of Novartis’ NVS Kymriah and Gilead Sciences, Inc.’s GILD Yescarta.
Bristol-Myers’ shares have lost 3.8% in the year so far against the industry’s growth of 11.5%.
We note that the approval of new drugs has become more important for the company as its blockbuster drug, Opdivo, is facing stiff competition from Merck’s MRK Keytruda.
Last month, the European Commission (EC) approved Reblozyl (luspatercept) for two indications — the treatment of adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk myelodysplastic syndromes (MDS) with ring sideroblasts, who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy, and those with transfusion-dependent anemia associated with beta thalassemia.
Bristol-Myers currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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