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Genentech's sBLA for Immunotherapy Tecentriq Accepted by FDA

NEW YORK – Genentech said on Wednesday that its supplemental Biologics License Application for atezolizumab (Tecentriq) was accepted by the US Food and Drug Administration and granted priority review.

The company is pursuing approval for the drug as a first-line, monotherapy option for advanced non-small cell lung cancer patients with high PD-L1 expression, and who don't harbor EGFR or ALK mutations. It expects to hear back from the FDA on its application by mid-June.

The supplemental application for the monoclonal antibody is supported by data from the randomized Phase III Impower110 study evaluating atezolizumab in PD-L1 biomarker-selected advanced NSCLC patients without ALK or EGFR mutations or previous chemotherapy treatment.

In the trial, chemotherapy-naïve patients with squamous or non-squamous NSCLC received either atezolizumab monotherapy or a chemotherapy regimen of the investigator's choice. Atezolizumab extended overall survival by 7.1 months over chemotherapy (20.2 months versus 13.1 months). Grade 3 and 4 treatment-related adverse events were reported in 12.9 percent of the atezolizumab cohort compared to 44.1 percent of the chemotherapy cohort.

Last December, the FDA approved atezolizumab in combination with chemotherapy (paclitaxel protein-bound and carboplatin) as a first-line option for adult patients with metastatic non-squamous non-small cell lung cancer who don't harbor EGFR or ALK genomic tumor aberrations, regardless of PD-L1 status.