Bristol Myers Squibb ( BMY Quick Quote BMY - Free Report) and partner 2seventy bio, Inc. ( TSVT Quick Quote TSVT - Free Report) faced a setback when the FDA informed the companies that the regulatory body would not be able to give a decision on the supplemental Biologics License Application (sBLA) for Abecma (idecabtagene vicleucel) by the original target date of Dec 16, 2023.
The sBLA is seeking approval of Abecma (idecabtagene vicleucel) for earlier lines of triple-class exposed relapsed or refractory multiple myeloma (“RRMM”) based on results from the phase III KarMMa-3 study.
Both companies also announced that the FDA’s Oncologic Drugs Advisory Committee (“ODAC”) will meet to review data supporting the sBLA for Abecma. However, the FDA has not yet confirmed the date of the ODAC meeting.
Abecma is a CAR T cell therapy indicated for adult patients with triple-class exposed RRMM after four or more prior lines of therapy. BMY and TSVT are jointly developing and commercializing Abecma in the United States.
Both companies anticipate that the committee will review data related to the secondary endpoint of overall survival (“OS”). Bristol Myers Squibb and 2seventy bio also plan to discuss with the FDA and participate in the ODAC meeting to reinforce the potential of Abecma to deliver significantly improved outcomes in patients with triple-class exposed RRMM in earlier lines of treatment.
The KarMMa-3 study met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (“PFS”) compared with standard regimens, significantly reducing the risk of disease progression or death versus standard regimens in patients with triple-class exposed RRMM.
The final PFS and OS data will be presented at a medical meeting next month.
Regulatory applications for Abecma in earlier lines of therapy for triple-class exposed RRMM based on the KarMMa-3 study results are also currently under review in various other countries.
The delay in a potential approval disappointed the investors. Shares of BMY were down 3.82% on the news, while TSVT shares tumbled 18.31%.
Bristol Myers’ shares have most likely also taken a hit due to
Bayer’s ( BAYRY Quick Quote BAYRY - Free Report) announcement of the late-stage study, OCEANIC-AF, investigating asundexian compared with direct oral anticoagulant Eliquis (apixaban) in patients with atrial fibrillation (“AF”) at risk for stroke is being stopped early due to the lack of efficacy.
BMY and partner Janssen Pharmaceuticals, Inc. are evaluating milvexian, an investigational oral factor XIa inhibitor for ischemic stroke, acute coronary syndrome and AF. The failure of BAYRY’s cardiovascular study has raised concerns for milvexian.
Shares of BMY have lost 32.3% year-to-date compared with the
industry's decline of 23%. Image Source: Zacks Investment Research
Bristol Myers is currently in transition mode as it shifts its mature product portfolio, which is facing generic competition, to new drugs.
The approval of additional new drugs and the label expansion of existing ones is essential for BMY as it looks to diversify its product base and offset the slowdown in top-line growth as Revlimid and Eliquis face generic competition.
BMY currently has a Zacks Rank #3 (Hold). You can see
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