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
Pfizer said Friday it reached a multi-year deal with Gilead Sciences to manufacture and supply Gilead's investigational antiviral remdesivir for COVID-19 patients. Ferring Pharmaceuticals US is recalling various nasal sprays citing superpotency or amounts of desmopressin higher than specified, the U.S. Food and Drug Administration announced in a statement. The recall involves all lots on the market of DDAVP Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE Nasal Spray 1.5 mg/mL. U.S. President Donald Trump has issued executive orders to ban Chinese mobile application TikTok as well as WeChat, citing a threat to national security and its economy. China's ByteDance Ltd. owns TikTok, a video-sharing mobile app, while Tencent Holdings Ltd. owns WeChat, a messaging, social media, and electronic payment app.
Follow RTT