NDA Accepted for Tepotinib Against Metastatic Non-Small Cell Lung Cancer
In late August, the FDA announced that it accepted and granted Priority Review to the new drug application (NDA) for once-daily, orally dosed tepotinib for the treatment of adult patients with metastatic non-small cell lung cancer whose tumors have a mutation that results in mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA-approved test. Read more.

Study Shows Efficacy of Selpercatinib in RET Fusion–Positive NSCLC
On August 27, 2020, the manufacturer announced phase l/ll study results of the registrational trial for selpercatinib, the first and only therapy indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). Selpercatinib is a novel, ATP-competitive, highly selective small-molecule inhibitor of RET kinase. Selpercatinib was designed to penetrate the central nervous system. Read more.

FDA Grants Priority Review of Trilaciclib for Treating Small Cell Lung Cancer
The FDA accepted a New Drug Application for trilaciclib for small cell lung cancer patients being treated with chemotherapy. Trilaciclib is a first-in-class investigational therapy intended to preserve bone marrow and immune system function during chemotherapy and enhance patient outcomes. In 2019, trilaciclib received an FDA Breakthrough Therapy Designation. Read more.