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FDA Panel Votes To Keep Accelerated Approval For Roche's Tecentriq In Metastatic Bladder Cancer

Roche (RHHBY) said Wednesday that the US Food and Drug Administration Oncologic Drugs Advisory Committee or ODAC voted 10 to 1 in favour of maintaining accelerated approval of Tecentriq or atezolizumab for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumours express high levels of PD-L1 as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

The FDA's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, with specific postmarketing requirements to confirm the clinical benefit and convert to regular approval.

Tecentriq was granted accelerated approval in 2017 for the treatment of adults with locally advanced or mUC who are not eligible for cisplatin-containing chemotherapy based on the positive overall response rate and duration of response results from the IMvigor210 study.

On 27 April, the ODAC voted 7 to 2 in favour of maintaining the accelerated approval of Tecentriq in combination with nab-paclitaxel for the treatment of people with PD-L1-positive, metastatic triple-negative breast cancer.

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