EMA recommends earlier use of Bristol Myers cell therapy for multiple myeloma

Dive Brief:

• Bristol Myers Squibb’s cell therapy for multiple myeloma, Abecma, should be approved for use in patients whose disease has progressed following two standard treatments, the European Medicines Agency’s drugs committee said Thursday.
• Once the European Commission ratifies the decision, Abecma would be cleared for earlier use. The treatment is currently only available after three rounds of treatment. But a recent study, KarMMA-3, found that Abecma, when administered earlier, reduced the risk of disease progression or death by nearly half compared to standard regimens.
• Bristol Myers and partner 2seventy bio are seeking a similar clearance in the U.S. as well. The FDA has delayed a decision, however, and intends to seek input from an advisory committee to review patient survival data.

Dive Insight:

If cleared by the European Commission, Abecma would be available for third-line use in the EU’s 27 member countries, a needed boost for a medicine that’s losing ground to Johnson & Johnson’s rival therapy Carvykti.

Both medicines are part of a new class of multiple myeloma treatments that work by targeting a protein called BCMA on diseased cells. They’ve proven powerfully effective in later lines of care, and are now moving earlier, as testing proves additional benefits.

Bristol Myers and J&J are racing to get U.S. approval of their respective treatments in the third-line setting, which would enable their cell therapies to be used after commonly used medicines drugs like Revlimid, Velcade and Darzalex.

J&J and partner Legend Biotech are seeking approval based on the results a study showing Carvykti reduced the risk of disease progression or death by 74% over standard treatment.

However, their requests come as the FDA has stepped up scrutiny of so-called CAR-T treatments. Earlier this week, the agency issued a new safety warning about the risk of secondary cancers following their use. Of the six FDA-approved CAR-T therapies, five have been linked directly to secondary T cell malignancies, although the FDA still believes their benefits outweigh their risks.

In three cases of secondary cancer flagged by regulators, diseased cells carried a protein signature of CAR-T treatments, “which indicates that the CAR-T product was most likely involved in the development of the T-cell cancer,” senior FDA officials Nicole Verdun and Peter Marks wrote in The New England Journal of Medicine.

Earlier this week, Legend disclosed the FDA intends to hold an advisory committee to review its request to broaden use of Carvykti.

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