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...
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Nivolumab/Ipilimumab Approved for Metastatic Non-Small Cell Lung Cancer

For patients with advanced non-small cell lung cancer (NSCLC) that test positive for programmed death-ligand 1 (PD-L1), the FDA just approved an effective treatment: nivolumab (Opdivo ®, Bristol Myers Squibb) plus ipilimumab (Yervoy®, Bristol Myers Squibb). A companion diagnostic, PD-L1 IHC 28.8 pharmDx (Agilent Technologies, Inc.), was also FDA approved for selecting patients with NSCLC for treatment with nivolumab/ipilimumab. Previously approved to treat advanced kidney cancer, advanced liver ...
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Selpercatinib Approved for RET-Mutant NSCLC, Thyroid Cancer

The FDA has approved selpercatinib (RetevmoTM, Eli Lilly), for adult patients with metastatic RET-fusion—positive NSCLC, adult and pediatric patients 12 years of age or older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and adult and pediatric patients 12 years of age or older with advanced or metastatic RET-fusion—positive thyroid cancer who require systemic therapy and are refractory to radioactive iodine. Selpercatinib is the first treatm...
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New Dosing Guidelines for Pembrolizumab FDA Approved

The FDA recently approved new dosing guidelines of 400 mg of pembrolizumab (KEYTRUDA®, Merck) to be taken every six weeks. The current recommended dose of pembrolizumab is 200 mg every three weeks. This new dosing regimen is approved across all adult indications of pembrolizumab. Pembrolizumab is FDA approved to treat several cancers including melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin lymphoma, primary mediastinal large B-...
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Anlotinib Improves Survival in Advanced NSCLC Subtypes

In patients with previously treated advanced non-small cell lung cancer (NSCLC), anlotinib increases progression-free survival in squamous cell carcinoma (SCC) and improves both overall and progression-free survival in adenocarcinoma, according to a subgroup analysis of a phase 3 trial. Treatment selection for NSCLC has become largely dependent on histological subtype. In the ALTER0303 trial, anlotinib, a multitargeted tyrosine kinase inhibitor (TKI), showed significant survival benefits among p...
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