Immuno-Oncology Resource Center
Immuno-Oncology Resource Center
May 13, 2020
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FDA delays application for investigational CAR-T for advanced multiple myeloma

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The FDA has issued a refusal to file letter regarding the biologics license application of the investigational chimeric antigen receptor T-cell therapy idecabtagene vicleucel, according to a joint statement from the manufacturers.

Idecabtagene vicleucel (bb2121) — an autologous CAR T-cell therapy that targets the B-cell maturation antigen when it is expressed on the surface of cancer cells — is in development for the treatment of adults with relapsed or refractory multiple myeloma.

The investigational CAR T-cell therapy is part of a codevelopment agreement between Bristol-Myers Squibb and bluebird bio.

The FDA issues a refusal to file letter when it considers a new drug or biologics license application incomplete, allowing the agent’s manufacturer to provide additional data before the application undergoes the approval process.

In the case of idecabtagene vicleucel, the FDA seeks more details on the Chemistry, Manufacturing and Control module of the application — filed in March — to complete the review, according to the joint statement.

The resubmittal does not require additional clinical or nonclinical data. Bristol-Myers Squibb plans to resubmit the application by the end of July.

As Healio previously reported, the FDA granted breakthrough therapy designation to idecabtagene vicleucel for treatment of patients with relapsed or refractory multiple myeloma.