FDA grants Roche's Tecentriq accelerated approval for a specific type of advanced bladder cancer

19 May 2016
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The US Food and Drug Administration has granted accelerated approval to Tecentriq (atezolizumab injection), from Genentech, the USA-based biotech subsidiary of Swiss pharma giant Roche (ROG: SIX), for the treatment of a specific type of bladder cancer.

The approval is for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Atezolizumab is a programmed death-ligand 1 (PD-L1) blocking antibody.

Tecentriq is the first product in its class to get US regulatory approval to treat advanced cases of this common type of bladder cancer. Urothelial carcinoma accounts for 90% of all bladder cancers and can also be found in the renal pelvis, ureter and urethra. The treatment will cost about $12,500 per patient a month, which is about in line with other PD-1 inhibitors.

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