Posted by Michael Wonder on 22 Jun 2019
FDA declines to approve Daiichi Sankyo's blood cancer treatment
21 June 2019 - Japan’s Daiichi Sankyo Co said on Friday the U.S. FDA has declined to approve its drug quizartinib as a treatment for adults with a type of blood cancer.
The decision follows an advisory committee meeting, held in May, where independent advisers to the U.S. regulator voted 8-3 against the drug’s approval to treat acute myeloid leukaemia patients with a specific genetic mutation called FLT3.
Several experts in the committee concurred that the data presented by the company was not strong enough to support an approval and called for further study.
