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FDA Awards Roche’s Tecentriq Priority Review

January 17, 2017

The FDA granted Roche’s Tecentriq a priority review for an expanded indication as a first-line treatment for patients who are unable to tolerate cisplatin-based chemotherapy.

The priority review status is based on a Phase II that found patients on Tecentriq maintained a high response rate to the therapy with longer follow ups, indicating that the therapy has the potential to provide significant improvements in the treatment of bladder cancer.

In 2016, FDA approved Tecentriq for patient with locally advanced or metastatic urothelial carcinoma as well as non-small cell lung cancer. The PDUFA deadline for the new indication is April 30.

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