Daiichi Sankyo Company. Ltd. has been granted breakthrough therapy designation by the U.S. Food and Drug Administration for its medicine quizartinib for treating a type of blood cancer.
The Japanese drugmaker said Aug. 1 that the designation was granted to quizartinib to treat patients with acute myeloid leukemia with the FLT3-ITD mutation who did not respond to initial treatment or whose cancer returned following treatment.
Daiichi said the FDA's decision was based on positive data from a phase 3 trial showing that patients who received quizartinib lived longer compared with those on chemotherapy.
The FDA's breakthrough therapy designation is designed to expedite the development and regulatory review of medicines that may demonstrate substantial benefit over currently approved treatments in order to quickly bring new treatment options to patients with serious diseases.