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Bristol-Myers Squibb BCMA CAR-T therapy Abecma receives EU CHMP support

 Last Update: 2021-09-06
 Source: Internet
 Author: User

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A few days ago, according to foreign media reports, Bristol-Myers Squibb (BMS) announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended to grant Abecma (idecabtagene vicleucel, ide-cel) conditional marketing authorization

CHMP adopted positive opinions based on the results of the pivotal Phase II KarMMa study, which evaluated the efficacy and safety of Abecma in 128 patients with severe pre-treatment and highly refractory multiple myeloma

The results showed that in the efficacy evaluation population (n=100), the overall response rate (ORR) of Abecma single infusion therapy was 72% (95%CI: 62-81), and 28% of patients achieved strict complete remission ( sCR; 95%CI: 19-38)

In this study, the safety of Abecma in treated patients has been well confirmed.

It is worth mentioning that Abecma is the world's first BCMA-directed CAR-T cell therapy to receive regulatory approval.

EC expects to make a final decision within 67 days after receiving the CHMP opinion

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