FDA Grants Priority Review to Selpercatinib for Lung and Thyroid Cancer Subsets
January 31st 2020The FDA has granted a priority review designation to a new drug application (NDA) for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion–positive non–small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC), and RET fusion–positive thyroid cancer.
FDA Grants Priority Review to Frontline Nivolumab-Ipilimumab Combo for NSCLC
January 16th 2020The FDA accepted and granted priority review to the supplemental biologics license application for nivolumab in combination with ipilimumab for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer.
Expert Talks Liquid Biopsies, Molecular Testing in Lung Cancer
January 3rd 2020Not all patients with advanced non–small cell lung cancer (NSCLC) are recommended for genomic testing when treated in a community setting, and are therefore not being appropriately tested for potential molecular drivers of their disease, explained Nathan Pennell, MD, PhD.
FDA Approves Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel for Lung Cancer Subset
December 4th 2019The FDA has approved atezolizumab (Tecentriq) in combination with carboplatin and nab-paclitaxel (Abraxane) for the first-line treatment of adult patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) who do not harbor EGFR or ALK molecular aberrations.
FDA Grants Durvalumab Priority Review for Small Cell Lung Cancer Treatment
December 2nd 2019The FDA has granted a priority review designation to a supplemental Biologics License Application (sBLA) for durvalumab (Imfinzi) for the frontline treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).1
MET Inhibitor Tepotinib is Granted a Breakthrough Designation by the FDA
September 11th 2019In about 3% to 5% of patients with NSCLC MET alterations are presented that can drastically change a patient's prognosis. Now, an investigational MET inhibitor called tepotinib was granted a breakthrough designation by the FDA, and it may prove beneficial for patients in this space.