Approved Drugs > Atezolizumab (TECENTRIQ)

Approved Drugs > Atezolizumab (TECENTRIQ)



FDA approved atezolizumab (TECENTRIQ, Genentech Oncology) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab. October 18, 2016.  More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm525780.htm

On October 18, 2016, FDA approved atezolizumab (TECENTRIQ, Genentech Oncology) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor 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. Compared with docetaxel, treatment with atezolizumab in the intended patient population in the two trials resulted in a 4.2 and a 2.9 month improvement in overall survival (OS), respectively.

The median OS in OAK was 13.8 months (95% confidence interval [CI] 11.8,15.7) in the atezolizumab arm compared to 9.6 months (95% CI 8.6,11.2) in the docetaxel arm (hazard ratio [HR]=0.74 [95% CI 0.63,0.87]; p=0.0004). The median OS in POPLAR was 12.6 months (95% CI 9.7, 16.0) and 9.7 months (95% CI 8.6, 12.0) (HR=0.69 [95% CI 0.52, 0.92]) for the atezolizumab and docetaxel arms, respectively.

The most common (greater than or equal to 20%) 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 (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 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.

 

Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761041lbl.pdf

 

 

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).