Plus   Neg

Astellas Pharma's Xospata Gets EU Approval To Treat AML With FLT3 Mutation

Astellas Pharma Inc. (ALPMY,ALPMY) announced Friday that the European Commission or EC has approved the oral once-daily therapy Xospata (gilteritinib) as a monotherapy for patients with relapsed or refractory acute myeloid leukemia or AML with a FLT3 Mutation.

The company noted that Gilteritinib has the potential to improve treatment outcomes for AML patients with two forms of the most common mutation—FLT3 internal tandem duplication or ITD and FLT3 tyrosine kinase domain or TKD mutation.

This approval is based on results from the Phase 3 ADMIRAL trial, which investigated gilteritinib versus salvage chemotherapy in patients with relapsed or refractory FLT3mut+ AML.

Patients treated with gilteritinib had significantly longer overall survival than those who received salvage chemotherapy.

Gilteritinib has been designated an orphan medicinal product and also received accelerated assessment from the European Medicines Agency earlier this year, which reduced the timeframe for approval.

Giovanni Martinelli, an investigator in the ADMIRAL trial, said, "AML is a rare cancer and patients with a FLT3 mutation have a particularly poor prognosis, with a median survival of less than six months following treatment with salvage chemotherapy. Gilteritinib is a new and clinically meaningful treatment option that provides a welcome advance for patients and health care professionals across the European Union."

Astellas said it reflected the impact from this approval in its financial forecast of the current fiscal year ending March 31, 2020.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
NBCUniversal unveiled Peacock, a free premium ad-supported streaming service with subscription tiers offering more than 600 movies and 400 series. Peacock will be available on April 15 for Comcast's Xfinity X1 and Flex customers and on July 15 for the rest of the country. NBC is offering Peacock... The number of Amazon Prime members in the U.S. is growing slowly, but steadily, a recent study has shown. According to the survey by the Consumer Intelligence Research Partners, LLC or CIRP, the number of Amazon Prime members in the U.S. is estimated to have risen to 112 million in December 2019 from just over 100 million in the same period of the prior year. Medical device manufacturer Cardinal Health will soon recall certain Level 3 surgical gowns or PreSource procedural packs that contain these gowns following warning that they may not be sterile, the U.S. Food and Drug Administration said in a statement. The health regulator said it is working with the company to find out the specific product lots that are impacted.
Follow RTT