EMA validates Bristol Myers Squibb’s applications for idecabtagene vicleucel and CC-486


22 May 2020 - Applications based on positive results from pivotal KarMMa study in relapsed and refractory multiple myeloma and QUAZAR-AML-001 study in acute myeloid leukaemia.

Bristol Myers Squibb today announced that the EMA has validated its marketing authorisation applications for both idecabtagene vicleucel and CC-486. 

Validation of each application confirms the respective submissions are complete and begins the EMA’s centralised review process.

Read BMS press release

Michael Wonder

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Michael Wonder

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