On Friday, March 15, 2024; the U.S. Food and Drug Administration (FDA) held an Oncologic Drugs Advisory Committee (ODAC) meeting to assess the risk-benefit profile of two CAR T-cell therapies: Johnson & Johnson and Legend Biotech’s Carvykti (ciltacabtagene autoleucel, or cilta-cel) and Bristol-Myers Squibb and 2seventy bio’s Abecma (idecabtagene vicleucel, or ide-cel).
The ODAC is tasked with reviewing and evaluating the safety and efficacy of cancer treatments, both marketed and investigational, and providing recommendations to the FDA Commissioner.
During this meeting, the panelists discussed the early use of Carvykti and Abecma in relapsed/refractory multiple myeloma (RRMM) patients, focusing on their potential as early as first relapse.
The International Myeloma Foundation (IMF) played a key role in the proceedings, with testimonials from IMF President & CEO Yelak Biru, IMF Board Members Jack Aiello and Sanjay Singh, and other patient advocates. Their input emphasized the importance of patient and clinician voices in the decision-making process.
For those who missed it, the full proceedings are available via a recorded YouTube video.
Carvykti: A Unanimous Vote (11-0)
In June 2023, Johnson & Johnson submitted a supplemental Biologics Licensing Application (sBLA) for Carvykti, alongside data from the CARTITUDE-4 trial, which showed a significant improvement in progression-free survival (PFS) for patients in the cilta-cel arm compared to standard therapy.
However, the trial also reported higher deaths due to adverse effects (11% in the cilta-cel arm versus 8% in the control arm), leading to a focus on early deaths during the ODAC discussions.
After reviewing the data, the committee voted unanimously (11-0) in favor of Carvykti, recognizing a favorable risk-benefit profile. The FDA is now set to make its final decision, with an anticipated Prescription Drug User Fee Act (PDUFA) date of April 5, 2024.
Abecma: Majority Vote (8-3)
For Abecma, results from the KarMMa-3 trial also demonstrated a statistically significant PFS benefit. The FDA sought the committee’s guidance on early deaths in the ide-cel arm, despite the promising survival data.
Ultimately, the committee voted 8-3 in favor of Abecma, acknowledging the potential benefits for patients with triple-class exposed RRMM. The FDA will consider this recommendation during its ongoing review of the sBLA.
Global Approvals and Next Steps
Abecma recently gained European Commission approval for early treatment of RRMM in the EU. This marks a critical milestone for bringing the therapy to more patients with advanced disease.
The Bottom Line
Both Carvykti and Abecma represent groundbreaking advances in the treatment of relapsed/refractory multiple myeloma. The ODAC’s recommendations reflect the belief that their benefits outweigh the known risks, offering new hope for patients. However, the final decision on their approval rests with the FDA.
