Atezolizumab got approved for non-small cell lung cancer
Atezolizumab got approved for non-small cell lung cancer
19 Oct 2016Atezolizumab treatment got approved by FDA (Food and Drug Administration) for patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy.
Patients with epidermal growth factor receptor (EGFR) or ALK genomic tumour aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab.
Atezolizumab is a programmed death-ligand 1 (PD-L1) blocking antibody that previously received FDA accelerated approval for the treatment of locally advanced or metastatic urothelial carcinoma that has progressed after platinum-containing chemotherapy.
This approval was based on two international, randomized, open-label clinical trials (OAK and POPLAR) that demonstrated consistent results in efficacy and safety in a total of 1137 patients with NSCLC.
Atezolizumab improves overall survival
Compared with docetaxel, treatment with atezolizumab in the intended patient population in the two trials resulted in a 4.2 and a 2.9 months improvement in overall survival (OS), respectively.
The median OS in OAK was 13.8 months in the atezolizumab arm compared to 9.6 months in the docetaxel arm.
The median OS in POPLAR was 12.6 months and 9.7 months for the atezolizumab and docetaxel arms, respectively.
Treatment’s side effects
The most common adverse reactions in patients in the primary safety analysis population (POPLAR trial) in patients treated with atezolizumab were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation.
The most common 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 included pneumonitis, hepatitis, colitis, and thyroid disease.
The recommended atezolizumab dose is 1200 mg administered as an intravenous infusion over 60 minutes every three weeks until disease progression or unacceptable toxicity.
Source: eCancer News