The approval is the fifth for the immunotherapy in lung cancer and the fourth in non–small cell lung cancer (NSCLC).
FDA today approved atezolizumab (Tecentriq) as an initial treatment for adults with metastatic non—small cell lung cancer (NSCLC) for certain patients with high programmed-death ligand-1 (PD-L1) expression, marking the fifth approval of the immunotherapy in lung cancer and the fourth in advanced NSCLC.
According to a statement from Genentech, the approval applies in metastatic NSCLC if PD-L1 is stained on at least 50% of tumor cells or if PD-L1 stained tumor-infiltration covers at least 10% of the tumor area, as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
A company spokesperson said Genentech also anticipates a decision on its supplemental biologics license application for atezolizumab in combination with bevacizumab for the treatment of patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.
“We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development for Genentech, said in the statement. “Today marks the fifth approval of Tecentriq in lung cancer, as we remain committed to providing an effective and tailored treatment option for every person diagnosed with this disease.”
FDA’s action is based upon an interim analysis from the phase 3 IMpower110 study, which found atezolizumab monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS, 20.2 vs 13.1 months; hazard ratio, 0.59, 95% CI, 0.40-0.89; P = .0106) in people with high PD-L1 expression (TC3/IC3-wild-type). Safety results appeared to be consistent with the drug’s known safety profile, and no new safety signals were identified. Grade 3 or 4 treatment-related adverse events were reported in 12.9% of people receiving atezolizumab compared with 44.1% of people receiving chemotherapy.