Ramucirumab/Erlotinib Approved: Metastatic Non-Small Cell Lung Cancer

The FDA has approved ramucirumab (Cyramza®, Eli Lilly and Company) in combination with erlotinib for patients with previously untreated advanced non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 substitution mutation. The approval was based on RELAY (NCT02411448), a phase 3 trial that enrolled 449 patients with untreated stage IV NSCLC. Eligible patients were at least 18 years old, had an Eastern Cooperative Oncology Group (ECOG) perfo...
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

FDA Approves Nivolumab/Ipilimumab/Platinum-Doublet Chemotherapy: NSCLC

Nivolumab (Opdivo®, Bristol Myers Squibb) plus ipilimumab (Yervoy®, Bristol Myers Squibb) in combination with 2 cycles of platinum-doublet chemotherapy has been FDA approved for treatment-naive patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Approval was based on the randomized, open-label trial CHECKMATE-9LA (NCT03215706). A total of 719 patients with met...
Continue reading

Brigatinib Approved for ALK-Positive Non-Small Cell Lung Cancer

For patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), the FDA has approved brigatinib (ALUNBRIG®, Takeda). In addition, the companion diagnostic for brigatinib, Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular, Inc.) has also been approved. A next-generation ALK inhibitor, brigatinib works by targeting a broad range of ALK mutations. Approval was based on an open-label, phase 3 trial (NCT02737501) that enrolled 275 patients with locally ...
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

Copyright © 2020 i3 Health. All rights reserved.