FDA grants priority review to Tecentriq for first-line treatment of advanced non-small cell lung cancer
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The FDA granted priority review to atezolizumab monotherapy as first-line treatment for patients with advanced nonsquamous or squamous non-small cell lung cancer without EGFR or ALK mutations and with high PD-L1 expression, according to a press release from the agent’s manufacturer.
The FDA based its decision, in part, on data from the phase 3 IMpower110 study, which demonstrated improved OS with atezolizumab (Tecentriq, Genentech/Roche), a PD-L1 inhibitor, compared with platinum-based chemotherapy among patients with high PD-L1 expression (20.2 months vs. 13.1 months; HR = 0.59; 95% CI, 0.39-0.89).
Researchers reported no new safety signals related to atezolizumab. A greater percentage of patients assigned chemotherapy vs. atezolizumab experienced grade 3 to grade 4 treatment-related adverse events (44.1% vs. 12.9%).
“In the IMpower110 study, Tecentriq alone demonstrated a significant improvement in OS compared with chemotherapy for people newly diagnosed with certain types of advanced non-small cell lung cancer,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, said in the release. “We are working closely with the FDA to bring this chemotherapy-free option to these patients as quickly as possible.”
The FDA is expected to make a decision on this application by June 19.