(Reuters) – Japan’s Daiichi Sankyo Co said on Friday the U.S. Food and Drug Administration 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 leukemia 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.
Daiichi said it would evaluate FDA’s complete response letter as well as determine next steps in the United States.
Quizartinib has only been approved for use in Japan.
Daiichi has been focusing on building its cancer drug franchise and is targeting a whopping 500 billion yen ($4.65 billion) in annual sales from the business in fiscal 2025 from 20 billion yen in 2017.
A second drug from the company, pexidartinib, that aims to treat a type of rare, non-cancerous tumor that usually affects joints and limbs is still under FDA review.
JUNE 21, 2019