FDA grants priority review to idecabtagene vicleucel for advanced multiple myeloma
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The FDA granted priority review to idecabtagene vicleucel for the treatment of certain adults with relapsed or refractory multiple myeloma, according to the agent’s developers.
The designation applies to use of idecabtagene vicleucel (Bristol Myers Squibb, bluebird bio) — often called ide-cel — by patients who have received at least three previous therapies, including an immunomodulatory agent, proteasome inhibitor and anti-CD38 antibody.
Ide-cel is an autologous chimeric antigen receptor T-cell therapy that targets the B-cell maturation antigen (BCMA) when it is expressed on the surface of cancer cells.
“Today’s priority review milestone recognizes the potential of this first anti-BCMA CAR T-cell therapy to address a critical unmet need of patients with multiple myeloma,” Stanley Frankel, MD, senior vice president of cellular therapy development at Bristol Myers Squibb, said in a press release. “We are pleased by the significant progress that is being made in partnership with patients and the multiple myeloma community to bring ide-cel to adults with relapsed and refractory multiple myeloma who are triple-class exposed and may benefit from an important new therapeutic option.”
Bristol Myers Squibb and bluebird bio submitted a biologics license application (BLA) for ide-cel in March, only to have the FDA issue a refusal to file letter that asked for more details on the Chemistry, Manufacturing and Control module of the application.
As Healio previously reported, the companies filed a new BLA with the additional information in July.
The application is based on results of 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 ide-cel at one of three dose levels.
Median follow-up was 13.3 months. 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). The safety analysis showed fewer than 6% of patients developed grade 3 or higher cytokine release syndrome or neurotoxicity.
“Today’s acceptance of the BLA for ide-cel for priority review by the FDA marks a key moment in our journey to bring this BCMA-directed CAR T-cell therapy to [patients with multiple myeloma] who are in desperate need of new options,” Joanne Smith-Farrell, PhD, chief operating officer in oncology of bluebird bio, said in the release. “Based on the body of evidence we have generated in an advanced, heavily pretreated patient population, our confidence in the potential of ide-cel as an important treatment option remains high. Together with our partners at Bristol Myers Squibb, we are committed to continue working with the FDA to deliver this promising therapy to patients in an expeditious manner.”
The FDA is expected to decide on the application by March 27.
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