Bristol-Myers Squibb, bluebird bio resubmit application for CAR-T to treat advanced myeloma
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Bristol-Myers Squibb and bluebird bio resubmitted a biologics license application to the FDA for idecabtagene vicleucel — an investigational chimeric antigen receptor T-cell therapy — for the treatment of adults with relapsed or refractory multiple myeloma.
The companies originally submitted the application in March.
The FDA subsequently issued a refusal to file letter to the manufacturers asking for more details on the Chemistry, Manufacturing and Control module of the application. The refusal to file letter allows the agent’s manufacturers to provide additional data before the application undergoes the full approval process.
Idecabtagene vicleucel (bb2121) is an autologous CAR T-cell therapy that targets the B-cell maturation antigen when it is expressed on the surface of cancer cells. The investigational therapy is part of a codevelopment agreement between Bristol-Myers Squibb and bluebird bio.
The application is based on results from the phase 2 KarMMa trial, presented during the ASCO20 Virtual Scientific Program.
The trial included 128 patients (median age 61 years; range, 33-78; 59% men) who received idecabtagene vicleucel at one of three dose levels. Patients had received a median six (range, 3-16) previous therapies, and 84% were triple-refractory to common treatments, including an immunomodulatory agent, proteasome inhibitor and anti-CD38 antibody.
Efficacy results showed an overall response rate of 73% (95% CI, 65.8-81.1) and a complete response rate of 33% (95% CI, 24.7-40.9).
As Healio previously reported, the FDA granted breakthrough therapy designation to idecabtagene vicleucel for treatment of patients with relapsed or refractory multiple myeloma.
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