EMA validates two filings from B-MS

23 May 2020

A week after the US Food and Drug Administration (FDA) refused to review idecabtagene vicleucel (ide-cel; bb2121), the European Medicines Agency (EMA) has accepted a filing for the CAR-T therapy.

US pharma major Bristol-Myers Squibb (NYSE: BMY) also announced that the EMA has validated its Marketing Authorization Application (MAA) for CC-486, another oncology treatment.

The MAA for ide-cel, which was co-developed with US biotech bluebird bio (Nasdaq: BLUE), is for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

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