logo
Plus   Neg
Share
Email

Seattle Genetics : EMA Validates MAA For Tucatinib

Seattle Genetics Inc. (SGEN) said that the European Medicines Agency (EMA) validated the Marketing Authorization Application or MAA for tucatinib, in combination with trastuzumab and capecitabine, for the treatment of adult patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least two prior anti-HER2 treatment regimens.

The EMA validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. Tucatinib is an oral, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2.

The New Drug Application for tucatinib was submitted to the U.S. Food and Drug Administration on December 23, 2019 under the Real-Time Oncology Review Pilot Program. The review of the tucatinib NDA is also being conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Elon Musk, the founder and CEO of Space Exploration Technologies, or SpaceX, said the aerospace company is planning to list its space internet venture, Starlink, after many years when revenue growth is smooth and predictable. In a tweet, Musk said, "We will probably IPO Starlink, but only several years in the future when revenue growth is smooth & predictable. Public market does *not* like erratic It's again that day of the year when coffee lovers celebrate their passion for the caffeinated beverage. It is National Coffee Day today in the U.S. when major food and beverage outlets nationwide promote the coffee culture with deals for coffee fans. In the U.S., major coffee outlets such as Starbucks, Dunkin' Donuts, Wawa, Krispy Kreme, Wendy's and Panera Bread give away free cups of coffee. The state of Ohio ordered General Motors to repay $28 million in tax credits after closing the Lordstown plant, which was in agreement to be operated until 2040. The Ohio Tax Credit Authority said the closure violated the terms of two economic development agreements signed by the company. In separate development, GM announced it is investing $71 million in two other Ohio manufacturing facilities.
Follow RTT