Drug Information Update- FDA approves new pill to treat certain patients with non-small cell lung cancer

Drug Information Update- FDA approves new pill to treat certain patients with non-small cell lung cancer FDA Division of Drug Information: Know the Moment It Happens The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation byContinue reading “Drug Information Update- FDA approves new pill to treat certain patients with non-small cell lung cancer”

FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung cancer

FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung cancer The U.S. Food and Drug Administration today approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected byContinue reading “FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung cancer”

Pembrolizumab injection

Pembrolizumab injection FDA granted accelerated approval to pembrolizumab (KEYTRUDA Injection, Merck Sharp and Dohme Corporation) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomicContinue reading “Pembrolizumab injection”