News from the FDA/CDC

FDA approves atezolizumab for advanced NSCLC


 

The Food and Drug Administration has approved the programmed death-ligand 1 (PD-L1) blocking antibody atezolizumab for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed during or following platinum-containing chemotherapy.

The FDA previously approved atezolizumab (Tecentriq) for the treatment of locally advanced or metastatic urothelial carcinoma that has progressed after platinum-containing chemotherapy.

Approval for treatment of NSCLC was based on results from the phase III OAK and phase II POPLAR trials that enrolled a total of 1,137 patients with NSCLC whose disease had progressed on platinum-containing chemotherapy. In OAK, median overall survival for patients assigned to atezolizumab was 13.8 months, compared with 9.6 months for patients assigned to docetaxel, as recently reported at the European Society for Medical Oncology Congress.

In POPLAR, overall survival was 12.6 months for patients receiving atezolizumab versus 9.7 months for those assigned to docetaxel, as reported at the European Cancer Congress in 2015.

The most common (greater than or equal to 20%) adverse reactions in patients treated with atezolizumab were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation, according to the FDA website. The most common (greater than or equal to 2%) grade 3-4 adverse events in patients treated with atezolizumab were dyspnea, pneumonia, hypoxia, hyponatremia, fatigue, anemia, musculoskeletal pain, AST increase, ALT increase, dysphagia, and arthralgia. Clinically significant immune-related adverse events for patients receiving atezolizumab have included pneumonitis, hepatitis, colitis, and thyroid disease.

The recommended dose is 1,200 mg administered as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity.

Patients with EGFR or ALK genomic tumor aberrations should not receive atezolizumab before having disease progression on FDA-approved therapy for these aberrations, the FDA said.

Full prescribing information is available on the FDA website.

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