Breakthrough status for AML drug

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to a drug in Phase III development for relapsed/refractory FLT3-ITD AML, a very aggressive form of the disease associated with poor prognosis and no approved targeted treatments.

This designation was granted to quizartinib, from Japanese pharma company Daiichi Sankyo (TYO: 4568) based on the results of the QuANTUM-R study, which showed that the selective FLT3 inhibitor prolongs overall survival as an oral, single agent compared to chemotherapy.

Arnaud Lesegretain, vice president, oncology research and development and head of the AML franchise at Daiichi Sankyo, said: “We look forward to working closely with the FDA to bring this potential new treatment option to patients as quickly as possible.”