Swiss pharma giant Roche (ROG: SIX) has edged closer to gaining approval from the US Food and Drug Administration (FDA) for a second bladder cancer indication with Tecentriq (atezolizumab).
Already approved by the FDA for people with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy or whose disease has worsened within 12 months of neoadjuvant or adjuvant platinum-based chemotherapy, Tecentriq is a monoclonal antibody designed to target and bind to the PD-L1 (programmed death-ligand 1) protein.
Roche has submitted a supplemental biologics license application (sBLA) for the drug to treat people with locally advanced or mUC who are ineligible for cisplatin chemotherapy, and are either previously untreated or have disease progression at least 12 months after receiving chemotherapy before or after surgery.
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