FDA approves Atezolizumab again for mNSCLC

The US Food and Drug Administration (FDA) approved Atezolizumab (Tecentriq, Genentech/Roche) in combination with chemotherapy nab-paclitaxel (Abraxane, Celgene) and carboplatin for the first-line treatment of metastatic non-squamous non-small-cell lung cancer (NSCLC) with no EGFR or ALK mutations. Atezolizumab was previously approved as an initial treatment for this same patient population, but in combination with Bevacizumab (Avastin, Genentech/Roche), Paclitaxel, and Carboplatin.

In March 2019, Atezolizumab made headlines as the first drug to be approved in 20 years for the initial treatment of extensive-stage small-cell lung cancer. The latest approval is based on efficacy and safety data from the phase-3 IMpower130 study, which showed that Atezolizumab plus chemotherapy yielded a statistically significant benefit in overall survival and progression-free survival (PFS) compared to chemotherapy alone.

The Atezolizumab-plus-chemotherapy combination also provided superior PFS compared with chemotherapy alone in the same ITT-WT population. Grade 3–4 treatment-related adverse events were reported in 73.2 percent of patients who received Atezolizumab plus chemotherapy versus 60.3 percent of patients who received chemotherapy alone. No new safety signals were identified with the combination. Atezolizumab is also approved by the FDA to treat adults with metastatic NSCLC who experience disease progression during or following platinum-containing chemotherapy.