Astellas submits NDA for gilteritinib approval in Japan and USA

Japanese drug major Astellas Pharma (TYO: 4503) today announced that, on March 23, it submitted a New Drug Application (NDA) for marketing approval of gilteritinib in Japan for the treatment of adult patients with FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia (AML).

Astellas also submitted an NDA for approval of gilteritinib in the same patient population to the US Food and Drug Administration on March 29, 2018, following the submission in Japan. The applications for marketing approval for gilteritinib are based on data from the ongoing pivotal Phase III ADMIRAL study investigating gilteritinib in adult patients with FLT3mut+ relapsed or refractory AML.

Gilteritinib, which was discovered by Astellas scientists, is at the vanguard of the company’s increasing investments in the oncology space. In an interview last month, Steven Benner, oncology head at Astellas, told The Pharma Letter he thought it was “a tremendously exciting time in the treatment of AML, after so many years of having no new medicines. Now we're able to pick which of these new precision medications we're able to give patients in addition to their standard treatment and hopefully we'll be able to achieve better results.”