Hematological Neoplasms

On February 28, 2022, the FDA officially approved Ciltacabtagene autoleucel, a BCMA CAR-T therapy developed by Legend Biotech/Janssen, for the treatment of relapsed or refractory multiple myeloma.

Cilta-cel is a chimeric antigen receptor T-cell (CAR-T) therapy targeting B-cell maturation antigen (BCMA), in which a patient’s T cells are genetically modified to express a chimeric antigen receptor (CAR) to recognize and eliminate BCMA-expressing cells.

Based on the results of the Phase 3 CARTITUDE-4 study, the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 11-0 in favor of a positive risk-benefit assessment for Carvykti®.

At 8:30 pm Beijing time on March 15, 2024, the FDA’s Oncologic Drugs Advisory Committee (ODAC) officially convened, with the meeting lasting over 9 hours.

Last week, the FDA released briefing documents from the Oncologic Drugs Advisory Committee (ODAC) meeting regarding Johnson & Johnson’s Carvykti (Ciltacabtagene autoleucel) and Bristol-Myers Squibb’s Abecma (Idecabtagene vicleucel), two CAR-T therapies. The documents highlighted the FDA’s concern over the higher early mortality rates observed in the treatment arms compared to the control arms in the clinical trials for these two CAR-T therapies.