By Blood Cancers Today Staff Writers - Last Updated: March 15, 2024
The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted on whether the risk-benefit assessment ciltacabtagene autoleucel (cilta-cel; CARVYKTI™) is sufficient evidence to recommend the approval of a supplemental Biologics License Application (sBLA) for an updated indication.
The 11-member panel of independent experts all voted in favor of the updated indication.
Prior to the vote, the ODAC meeting reviewed overall survival outcomes and risks and benefits of treatment reported in the CARTITUDE-4 study that enrolled patients in the updated population.
ODAC member, Ranjana Advani, MD, at Stanford Cancer Institute, noted, “I think the benefit is a pretty robust. The small number of patients in the beginning — largely the deaths — are related to not getting the treatment or inadequate bridging or delay or COVID are not completely understood, but I think overall, it was a very positive trial with significant benefit to most patients.”
If accepted by the FDA, the indication for cilta-cel will be updated to adult patients with relapsed or refractory multiple myeloma who are refractory to lenalidomide and have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.
While positive recommendations from FDA advisory committees are nonbinding, the FDA typically follows positive recommendations when making regulatory decisions.
Cilta-cel was previously approved by the FDA for the treatment of patients with relapsed or refractory MM after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This approval was supported by the earlier CARTITUDE-1 study.
At that time, CARTITUDE-1 principal investigator, Sundar Jagannath, MD, from The Tisch Cancer Institute of Icahn School of Medicine at Mount Sinai, said, “The responses in the CARTITUDE-1 study showed durability over time and resulted in the majority of heavily pretreated patients achieving deep responses after 18-month follow-up . . . the approval of cilta-cel provides physicians an immunotherapy treatment option that offers patients an opportunity to be free from anti-myeloma therapies for a period of time.”
Original Source: Cilta-Cel Receives Positive Recommendation for Updated Indication in Myeloma | Blood Cancers Today