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ZURICH (Reuters) - Roche (ROG.S) 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 Food and Drug Administration 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.
Reporting by John Miller, editing by John Revill