Posted by Michael Wonder on 22 May 2020
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.
