Daiichi Sankyo Company, Limited has announced the launch of VANFLYTA® (quizartinib), an oral FLT3 inhibitor, in Japan for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML). FLT3 gene mutations are one of the most common genetic abnormalities in AML. FLT3-ITD is the most common FLT3 mutation, affecting approximately one in four patients with AML.
Marketing approval of VANFLYTA by Japan’s Ministry of Health, Labor and Welfare (MHLW) in June 2019 was based on the results of the global pivotal phase 3 QuANTUM-R study and a phase 2 study of VANFLYTA in Japanese patients with relapsed/refractory FLT3-ITD AML. Results of QuANTUM-R were published in The Lancet Oncology. Results from the phase 2 study in Japan patients were recently published in the International Journal of Hematology.
“We are proud to launch VANFLYTA in Japan making it available to both physicians and patients as an important new therapeutic option with a survival benefit over salvage chemotherapy for the treatment of patients with relapsed/refractory FLT3-ITD AML,” said Takashi Ikegami, PhD, Vice President, Head of Specialty Marketing in Japan, Daiichi Sankyo. “Now patients have access to a treatment that targets FLT3-ITD, a driver mutation in AML linked to poor prognosis and aggressive disease that results in increased relapsed rate and reduced overall survival for patients compared to those without this mutation.”