FDA Approves Atezolizumab (Tecentriq) for Treatment of Metastatic NSCLC

Atezolizumab (Tecentriq) is now approved by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic non-small cell lung cancer (NSCLC), according to a press release.¹

Based primarily on the results of the OAK (A Randomized Phase 3 Study of Atezolizumab Compared to Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy; ClinicalTrials.gov Identifier: NCT02008227) and POPLAR (A Randomized Phase 2 Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy; ClinicalTrials.gov Identifier: NCT01903993) studies, the drug is approved for patients whose diseases progress with platinum-based chemotherapies, or for those with EGFR or ALK actionable mutations.

The OAK study showed about a 4-month average survival benefit over docetaxel (13.8 months compared to 9.6). Treatment was given to the 425 patients of each cohort.

Serious adverse events with atezolizumab include pneumonitis, hepatitis, colitis, glandular issues, neuropathy, meningitis, encephalitis, and eye inflammation.

Atezolizumab targets the PD-L1 protein, but is efficacious regardless of PD-L1 expression.

Reference

1. FDA Approves Genentech’s Cancer Immunotherapy Tecentriq (Atezolizumab) for People with a Specific Type of Metastatic Lung Cancer. Genentech website. https://www.gene.com/media/press-releases/14641/2016-10-18/fda-approves-genentechs-cancer-immunothe. Updated October 18, 2016. Accessed October 19, 2016.