FDA push­es back PDU­FA date for Dai­ichi's AML drug quizar­tinib over REMS up­dates

Dai­ichi Sankyo said the FDA needs more time to re­view the NDA for its FLT3 drug quizar­tinib, ex­tend­ing the PDU­FA date by three months un­til Ju­ly 24.

The agency said it needs more time to re­view re­quest­ed changes to the Risk Eval­u­a­tion and Mit­i­ga­tion Strate­gies (REMS) in­clud­ed in the com­pa­ny’s ap­pli­ca­tion, ac­cord­ing to a press re­lease is­sued Thurs­day.

The FDA’s REMS pro­gram mon­i­tors med­ica­tions with a high po­ten­tial for se­ri­ous ad­verse ef­fects. Dai­ichi did not in­clude de­tails about the re­quest­ed up­dates to REMS.

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