FDA grants accelerated approval for Astellas, Seattle Genetics' bladder cancer drug

U.S. Food and Drug Administration said on Wednesday it approved Astellas Pharma Inc and Seattle Genetics' experimental drug to treat advanced bladder cancer, about three months ahead of schedule. Shares of Seattle Genetics were up 6% at $119.05 after the bell. The drug, Padcev, is the first FDA approved treatment in the United States for patients with advanced or metastatic urothelial cancer, the companies said. The drug will treat patients with advanced bladder cancer whose disease has progressed even after treatment with immunotherapy and chemotherapy. The American Cancer Society estimates 17,670 people will die from bladder cancer in the United States this year. The continued approval of the drug may depend upon verification of clinical benefit in confirmatory trials, the companies said, adding that a late-stage study is underway. The FDA's accelerated approval program allows conditional approval of a medicine that fills an unmet medical need for a serious condition.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!