FDA speeds up review of Roche’s Tecentriq to treat bladder cancer

FDA speeds up review of Roche’s Tecentriq to treat another bladder cancer

FDA speeds up review of Roche's Tecentriq to treat  bladder cancer
The logo of Swiss pharmaceutical company Roche is seen outside their headquarters in Basel (Copyright Reuters 2017)

Roche said on Monday that U.S. regulators agreed to priority review of its Tecentriq immunotherapy for an additional type of bladder cancer, a boost to the Swiss drugmaker’s bid to expand indications for the drug.

Under the accelerated review, the FDA will make a decision within six months on Roche’s application for Tecentriq’s use in patients with metastatic urothelial carcinoma who are ineligible for cisplatin chemotherapy and who are either previously untreated or have disease progression at least 12 months after receiving chemotherapy before or after surgery.

Tecentriq was approved last year for another group of patients with locally advanced or metastatic urothelial carcinoma as well as non-small cell lung cancer, the most-common form of lung cancer.


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