Ciltacabtagene Autoleucel

Chimeric antigen receptor T-cell therapy has induced exceptional response rates among patients with relapsed or refractory multiple myeloma compared with conventional options, according to a speaker at Chemotherapy Foundation Symposium.

The FDA has delayed its decision on a biologics license application for ciltacabtagene autoleucel, a chimeric antigen receptor T-cell therapy for treatment of adults with relapsed or refractory multiple myeloma.

Neurologic adverse events were generally manageable in patients with multiple myeloma after receiving ciltacabtagene autoleucel, a BCMA-directed CAR T-cell therapy, according to CARTITUDE-2 data presented at the virtual ASCO Annual Meeting.

The last few years have yielded “incredible numbers of new drugs approved and under development” in multiple myeloma, Cristina Gasparetto, MD, director of the multiple myeloma program at Duke University, told Healio in a video interview.

Ciltacabtagene autoleucel, a BCMA-directed CAR T-cell therapy, yielded an overall response rate of 97% in 97 heavily pretreated patients with relapsed or refractory multiple myeloma, according to data presented at the virtual ASCO Annual Meeting.

More than 80% of patients with relapsed or refractory multiple myeloma remained alive 18 months after receiving a single infusion of ciltacabtagene autoleucel, according to the latest results of a phase 1/phase 2 clinical trial.

The FDA granted priority review to ciltacabtagene autoleucel, a chimeric antigen receptor T-cell therapy, for the treatment of relapsed or refractory multiple myeloma, according to the agent’s manufacturer.

An independent panel unanimously agreed that chimeric antigen receptor T-cell therapy provides clinical benefit superior to the current standard of care for patients with relapsed or refractory multiple myeloma.

The value of chimeric antigen receptor T-cell therapy for patients with heavily pretreated multiple myeloma can be significant, regardless of whether it leads to a complete and lasting remission.

Janssen and Legend Biotech have begun a rolling submission of a biologics license application to the FDA for ciltacabtagene autoleucel to treat adults with relapsed or refractory multiple myeloma.