A U.S. FDA advisory committee has voted in favor of two different cell therapies — Johnson & Johnson and Legend Biotech’s Carvykti and Bristol Myers Squibb and 2seventy bio's Abecma — for earlier treatment of patients with relapsed/refractory multiple myeloma.
The Oncologic Drugs Advisory Committee (ODAC) voted unanimously (11-0) in favor of Carvykti for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent and are refractory to lenalidomide.
Carvykti, the result of a December 2017 license and collaboration agreement between J&J's Janssen Biotech and Legend Biotech, was first approved in February 2022 for the treatment of patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy. The treatment is a B-cell maturation antigen-directed genetically modified autologous chimeric antigen receptor T-cell therapy.
According to Legend, a supplemental BLA supported by the CARTITUDE-4 study is currently under review by the FDA with a target PDUFA date of April 5, 2024.
The ODAC also voted in favor (8-3) of Abecma for patients with triple-class exposed relapsed or refractory multiple myeloma.
Abecma, jointly developed and commercialized by BMS and bluebird bio, which was spun out to create 2seventy bio, became the first cell-based gene therapy approved by the FDA for the treatment of multiple myeloma in March 2021. The drug was approved for use in adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy.
The partners' supplemental BLA seeking the expanded use of Abecma, a CAR-T cell therapy that recognizes and binds to the B-cell maturation antigen on the surface of multiple myeloma cells, originally had a PDUFA date of December 16, 2023. Back in November, the FDA delayed its decision when it decided that the ODAC would meet to discuss results from the pivotal phase 3 KarMa-3 study of Abecma in earlier lines of triple-class exposed relapsed or refractory multiple myeloma.
According to BMS, the FDA has not yet assigned a new target action date for review of the sBLA.
The two positive votes come in spite of FDA briefing docs that specifically noted the agency's interest in the committee's opinion on higher rates of early deaths noted in the treatment arms of Carvykti's CARTITUDE-4 trial and Abecma's KarMMa-3 trial.
Earlier this year, the FDA required that manufacturers add a boxed warning to both drugs, among other CAR-T cell therapies, warning that the treatments themselves may cause cancers.
