Roche’s Tecentriq scores another bladder cancer Priority Review

pharmafile | January 9, 2017 | News story | Sales and Marketing Roche, bladder cancer, tecentriq 

Roche has announced that its immunotherapy drug Tecenetriq (atezolizumab) has been awarded Priority Review by the FDA for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) specifically in patients for whom cisplatin chemotherapy is not suitable and who have either not received first-line treatment or have disease progression at least 12 months after receiving chemotherapy before or after surgery.

The treatment was previously granted accelerated approval by the FDA for use against the disease last year. mUc is a type of advanced bladder cancer characterised by typically poor prognoses and limited treatment options. The new decision was based on results of the IMvigor210 Phase 2 trial, which found that mUc patients treated with Tecentriq showed an objective response rate (ORR) of 84%. Under this new status, the FDA will make a decision on the drug’s use for this indication within six months.

Sandra Horning, Roche’s CMO and head of Global Product Development, remarked on the news: “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. 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.”

The drug has already seen approval from the FDA for the treatment of metastatic non-small cell lung cancer, granted in October last year. The news further reinforces the strength and utility of the Swiss firm’s drug, which could spell increased competition for immunotherapy rivals including BMS’ Opdivo and MSD’s Keytruda in the coming year.

Matt Fellows

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