FDA Advisers Endorse Carvykti and Abecma for Earlier Use, Despite Early Death Concerns

Washington, DC – After concerns about potential early deaths, the FDA advisers have endorsed J&J and Legend’s Carvykti, as well as BMS’ Abecma for use in earlier stages of treatment. Despite initial worries, the FDA advisory committee has ultimately given their support to the new treatment options. Carvykti, a drug developed by Johnson & Johnson and Legend Biotech, and Abecma, from Bristol Myers Squibb, have received approval for earlier use in certain circumstances. This decision …

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New Concerns Arise Over Early Deaths in CAR-T Myeloma Trials with Carvykti and Abecma

Washington, D.C. – The Food and Drug Administration (FDA) has raised concerns about early deaths in clinical trials for CAR-T therapies used to treat multiple myeloma. Specifically, the FDA flagged the experimental treatments Carvykti from J&J and Legend, as well as Abecma from Bristol Myers Squibb. During the trials, patients receiving these CAR-T therapies experienced unexpected deaths, prompting the FDA to issue a warning. While CAR-T therapies have shown promising results in treating certain types …

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