Roche's Genentech unit announced that the FDA granted accelerated approval to Tecentriq (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy.
The anti-PD-L1 immunotherapy was authorised by the FDA last year for people with locally advanced or mUC who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before or after surgery. "We are pleased that Tecentriq will now be available to more people with advanced bladder cancer, including those who are unable to receive initial treatment with cisplatin chemotherapy," commented Sandra Horning, Roche's chief medical officer.
According to Roche, the accelerated approval for Tecentriq as an initial treatment for mUC is based on tumour response rate and duration of response data from the Phase II IMvigor210 study. The drugmaker indicated that it is currently evaluating Tecentriq in the confirmatory Phase III IMvigor211 trial, which is comparing the anti-PD-L1 immunotherapy to chemotherapy as initial treatment in people with a specific type of advanced bladder cancer and in people whose bladder cancer has progressed on at least one prior platinum-containing regimen.
Tecentriq is also approved in the US for the treatment of people with metastatic non-small-cell lung cancer who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumour has EGFR or ALK gene abnormalities.
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