Bristol-Myers Gets Refusal to File Letter for CAR-T Therapy BLA

Bristol Myers Squibb BMY and partner bluebird bio, Inc. BLUE announced that the FDA has refused to review their biologics license application (“BLA”) for CAR-T therapy candidate, idecabtagene vicleucel (ide-cel; bb2121). The BLA sought approval of the candidate as a treatment for heavily pre-treated relapsed and refractory multiple myeloma (“MM”).

The companies received a Refusal to File letter from the FDA stating that the regulatory authority has determined, following a preliminary review, that the BLA’s Chemistry, Manufacturing and Control module requires further detail to complete the review. However, no additional clinical or non-clinical data have been requested by the agency.

Bristol-Myers is planning to re-submit the BLA before July end. Please note that the BLA was submitted to the FDA in March based on data from the pivotal phase II KarMMa study on the BCMA-targeted CAR-T therapy candidate. The study met its primary endpoint and key secondary endpoint demonstrating deep and durable responses in a heavily pre-treated multiple myeloma patient population.

Notably, idecabtagene vicleucel is being developed as part of a co-development, co-promotion and profit-sharing agreement between Bristol-Myers and bluebird. The candidate was added to Bristol-Myers’ portfolio post the acquisition of Celgene Corporation last November.

Idecabtagene vicleucel is also being evaluated in other clinical studies to address patients with MM in earlier-line settings including the newly diagnosed ones.

Bristol-Myers’ shares have decline 1.4% so far this year compared with the industry’s decrease of 1.7%.

The company also announced three-year follow-up data from part 1 of the phase III CheckMate -227, which is evaluating a combination of its PD-L1 inhibitor, Opdivo, and another cancer drug, Yervoy, in first-line metastatic non-small cell lung cancer (“NSCLC”).  Please note that the combination is approved for this indication.

Data from the study demonstrated that treatment with the combination regimen provided sustained improvements in overall survival, after a median follow-up of more than three years. Among patients who were treated with Opdivo plus Yervoy, 33% survived compared to 22% for chemotherapy alone.

Meanwhile, Opdivo plus Yervoy regimen is under priority review in the United States as a treatment for first-line metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations.

Lung cancer is a very important indication for Opdivo, given its market potential. The drug’s sales were sluggish in the first quarter as it faced stiff competition from Merck’s MRK Keytruda and Roche’s RHHBY Tecentriq. AstraZeneca’s Imfinzi is also approved for lung cancer.

BristolMyers Squibb Company Price

 

BristolMyers Squibb Company Price

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Zacks Rank

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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