Genentech announced that the Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq (atezolizumab) for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) in patients who are ineligible for cisplatin chemotherapy.

Prior to this, Tecentriq was approved for use in locally advanced or mUC in patients with disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before or after surgery. 

The accelerated approval was based on tumor response rate and duration of response from the Phase 2 IMvigor210 study. Its continued approval for this indication may be dependent upon verification and description of clinical benefit in confirmatory trials. 

IMvigor210 was an open-label, multicenter, single-arm study that evaluated Tecentriq in patients with locally advanced or mUC regardless of PD-L1 expression. In Cohort 1 (n=119), patients who were ineligible for cisplatin-containing chemotherapy and were previously untreated or had disease progression at least 12 months after neoadjuvant or adjuvant chemotherapy, were given 1200mg IV Tecentriq every 3 weeks until unacceptable toxicity or disease progression. 

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The study’s primary endpoint was objective response rate (ORR). In Cohort 1, the ORR was 23.5% (95% CI: 16.2, 32.2). Complete response was seen in 6.7% of patients and partial response was seen in 16.8% of patients. 

Tecentriq, a programmed death-ligand 1 (PD-L1) blocking antibody, is also approved for the treatment of people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.

Tecentriq is available as a 60mg/mL strength solution for IV infusion in 20mL single-use vials.

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