FDA Archives

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 …

FDA Panel Votes to Support CAR-T Therapies by Johnson & Johnson and Bristol Myers Squibb for Multiple Myeloma Treatment

Silver Spring, Maryland – An FDA advisory committee voted overwhelmingly in favor of recommending the approval of CAR-T therapies from Johnson & Johnson, Legend Biotech, Bristol Myers Squibb, and 2seventyBio for the treatment of multiple myeloma. The committee’s support for these therapies highlights a significant milestone in the ongoing discussions surrounding the use of CAR-T treatments in cancer care. During the committee meeting, concerns were raised about the higher rate of early deaths observed in …