FDA/CDC

FDA approves atezolizumab combo as first line for advanced NSCLC


 

The Food and Drug Administration has approved atezolizumab (Tecentriq) in combination with paclitaxel and carboplatin chemotherapy for first-line treatment of adults with metastatic, nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

FDA icon

Atezolizumab has been previously approved in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of adults with metastatic NSCLC with no EGFR or ALK genomic tumor aberrations. The monoclonal antibody is also approved to treat adults with metastatic NSCLC who have disease progression during or following chemotherapy, and for those with extensive-stage SCLC.

The current approval was based on a demonstrated improvement in overall survival in the phase 3 IMpower130 trial (NCT02367781). Median overall survival for advanced NSCLC patients who received atezolizumab in combination with chemotherapy was 18.6 months, compared with 13.9 months for patients who received chemotherapy alone (hazard ratio, 0.80; 95% confidence interval, 0.64-0.99; P = .0384) in the intention-to-treat wild-type population of 681 patients.

Grade 3-4 treatment-related adverse events were reported in 73.2% of people receiving atezolizumab plus chemotherapy, compared with 60.3% of people receiving chemotherapy alone, according to the company press release.

Recommended Reading

Nivolumab benefit for NSCLC persists at 5-year follow-up
MDedge Hematology and Oncology
Lung cancer on the decline, but still higher among men than women
MDedge Hematology and Oncology
Atezolizumab bests chemo in NSCLC patients with high PD-L1 expression
MDedge Hematology and Oncology
‘You had me at hello’: ESMO studies confirm survival benefits in NSCLC and breast cancer
MDedge Hematology and Oncology
Lorlatinib induces deep responses in ROS1-positive NSCLC
MDedge Hematology and Oncology
Neoantigen vaccine appears safe and active in NSCLC
MDedge Hematology and Oncology
Not all lung cancer patients receive treatment
MDedge Hematology and Oncology
Expanding the reach of available cancer therapies
MDedge Hematology and Oncology
Large state disparities seen for lung cancer screening
MDedge Hematology and Oncology
Single-fraction radiation just misses mark for spinal compression relief
MDedge Hematology and Oncology