The US Food and Drug Administration (FDA) has granted the PD-L1-targeting monoclonal antibody atezolizumab (Tecentriq) accelerated approval for first-line treatment of advanced or metastatic urothelial carcinoma — regardless of PD-L1 expression status — in patients who are ineligible for frontline cisplatin chemotherapy, according to a press release.1
Atezolizumab was previously FDA-approved for second-line treatment for advanced urothelial carcinomas refractory to platinum-containing chemotherapies or that had progressed within 12 months of neoadjuvant or adjuvant chemotherapy.
The FDA’s Accelerated Approval Program allows conditional approval of medications addressing unmet medical needs based on early evidence of clinical benefit; continued approval depends on confirmatory data verifying benefit.
This accelerated approval was based on data from the phase 2 IMvigor210 (ClinicalTrials.gov Identifiers: NCT02951767, NCT02108652) clinical trial, an open-label, multicenter, single-arm study, in which 119 patients had an objective response rate of 23.5% (complete response 6.7%; partial response 16.8%).
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Serious adverse events potentially associated with atezolizumab include pneumonitis, hepatitis, colitis, endocrinopathies of the pituitary, thyroid, adrenal glands, and pancreas, neuropathy, meningitis, encephalitis, uveitis, and severe infections and infusion reactions. In the IMvigor210 trial, atezolizumab was discontinued because of treatment-related toxicities in 5 of 119 patients (4.2%).
- FDA grants Genentech’s TECENTRIQ (atezolizumab) accelerated approval as initial treatment for certain people with advanced bladder cancer [news release]. San Francisco, CA: BusinessWire; April 17, 2017. http://www.businesswire.com/news/home/20170417005937/en/FDA-Grants-Genentech%E2%80%99s-TECENTRIQ-Atezolizumab-Accelerated-Approval. Accessed April 18, 2017.