Exciting news for the myeloma community emerged last week with the release of the FDA Oncologic Drugs Advisory Committee (ODAC) meeting results from March 15. At this public session, ODAC panelists discussed the risk-benefit profiles of CAR T-cell therapies, specifically Bristol Myers Squibb and 2seventy bio’s Abecma (ide-cel) and Johnson & Johnson and Legend Biotech’s Carvykti (cilta-cel).
Following thorough deliberation, the ODAC panel unanimously favored Carvykti (11-0) and largely supported Abecma (8-3). These recommendations were integral to the FDA’s review of supplemental Biologics License Applications (sBLAs) submitted by both companies. The IMF is thrilled to announce the FDA’s subsequent approvals for both CAR T therapies.
Abecma: Expanded Approval for Earlier Use in RRMM
On April 4, 2024, the FDA approved Abecma for treating adult patients with relapsed or refractory multiple myeloma (RRMM) who have tried two or more previous therapies. This expansion, based on KarMMa-3 trial results, provides Abecma to patients with triple-class exposure after two prior treatment lines. According to Bristol Myers Squibb, Abecma offers a threefold increase in progression-free survival over standard therapies, providing meaningful treatment-free intervals.
Carvykti: Approved for Use After a Single Prior Therapy
One day later, on April 5, the FDA approved Carvykti for adult patients with RRMM who have tried at least one prior therapy. Carvykti, targeting BCMA, is the first therapy approved for multiple myeloma as early as first relapse. Based on the CARTITUDE-4 study, it showed a 59% reduction in disease progression or death compared to standard treatments.
Both therapies come with boxed warnings and comprehensive safety profiles for potential adverse effects, including Cytokine Release Syndrome (CRS) and neurologic toxicities.
Looking Ahead: ODAC’s Upcoming Discussion on MRD
The IMF remains at the forefront of these ODAC proceedings, with another key meeting set for April 12. This meeting will discuss using minimal residual disease (MRD) as an endpoint in myeloma trials. As always, the IMF will advocate on behalf of the myeloma community to ensure their voice is heard and will continue providing updates on these crucial developments.
