publication date: Jan. 25, 2017

Regulatory Actions Tecentriq receives priority review for treatment of urothelial carcinoma

Genentech said FDA accepted the company’s supplemental Biologics License Application and granted Priority Review for Tecentriq (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin chemotherapy, and are either previously untreated or have disease progression at least 12 months after receiving chemotherapy before surgery or after surgery.

Urothelial carcinoma accounts for 90 percent of all bladder cancers and can also be found in the renal pelvis, ureter, and urethra.

“In May 2016, Tecentriq became the first treatment approved by the FDA for people with previously treated advanced bladder cancer in more than 30 years,” said Sandra Horning, chief medical officer and head of Global Product Development. “We are committed to continue working with the FDA to make Tecentriq available to more people with this type of advanced bladder cancer, specifically those who are unable to tolerate cisplatin-based chemotherapy as an initial treatment.”

This sBLA submission for Tecentriq is based on results from the phase II IMvigor210 study, and the FDA will make a decision on approval by April 30, 2017. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of … Continue reading CCL Jan 2017 – Tecentriq receives priority review for treatment of urothelial carcinoma

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