Atezolizumab Combo Approved in BRAF V600-Mutant Melanoma

The FDA has approved a new indication for atezolizumab (Tecentriq®, Genentech) in combination with cobimetinib (Cotellic®, Genentech) and vemurafenib (Zelboraf®, Genentech and Daiichi-Sankyo) for the treatment of BRAF V600-mutated advanced melanoma. The approval was granted under a supplemental Biologics License Application (sBLA) with priority review. The approval was based on data from the double-blind, international phase 3 IMspire150 trial (NCT02908672), for which 514 patients with unresecta...
Continue reading

Atezolizumab/Bevacizumab Approved for Unresectable Hepatocellular Carcinoma

The FDA has approved atezolizumab (Tecentriq®, Genentech, Inc.) in combination with bevacizumab (Avastin®, Genentech, Inc.) for patients with locally advanced unresectable or metastatic hepatocellular carcinoma (HCC) who have not previously received systemic therapy. The approval was based on IMbrave150 (NCT03434379), a phase 3 trial that enrolled 501 patients with unresectable HCC. Patients were randomized in a 2:1 ratio to receive atezolizumab 1,200 mg administered intravenously followed by be...
Continue reading

Atezolizumab for PD-L1–High Non-Small Cell Lung Cancer: David Spigel, MD

Atezolizumab (Tecentriq®, Genentech, Inc.) was recently approved by the FDA for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with high expression of programmed death ligand-1 (PD-L1). The approval was based on IMpower110, a phase 3 trial led by David Spigel, MD, Chief Scientific Officer and Director of the Lung Cancer Research Program at Sarah Cannon Research Institute in Nashville, Tennessee. In this interview with i3 Health, Dr. Spigel discusses the s...
Continue reading

Atezolizumab Approved for PD-L1–High Non-Small Cell Lung Cancer

The FDA has expanded the approval of atezolizumab (Tecentriq®, Genentech, Inc.) to include adults with untreated metastatic non-small cell lung cancer (NSCLC) with high expression of programmed death ligand-1 (PD-L1). High PD-L1 expression is defined as PD-L1 staining on at least 50% of tumor cells or tumor-infiltrating immune cells covering at least 10% of the tumor area. In addition, the FDA has approved a companion diagnostic device, the Ventana PD-L1 (SP142) Assay (Ventana Medical Systems, I...
Continue reading

Atezolizumab Plus nab-Paclitaxel and Carboplatin FDA Approved for Metastatic NSCLC

Atezolizumab (Tecentriq®, Genentech Inc.) in combination with nab-paclitaxel and carboplatin is now FDA approved as first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. Atezolizumab, previously approved to treat extensive-stage small cell lung cancer, metastatic urothelial carcinoma, and metastatic triple-negative breast cancer, works as a monoclonal antibody and stimulates the immune system by block...
Continue reading

Copyright © 2020 i3 Health. All rights reserved.