Recently, the FDA granted approval to cemiplimab (Libtayo®, Regeneron Pharmaceuticals) for the treatment of patients with locally advanced or metastatic basal cell carcinoma (BCC) who were previously treated with a hedgehog pathway inhibitor (HHI) or who are ineligible for HHI therapy. In this interview, Karl Lewis, MD, Professor of Medical Oncology at the University of Colorado Anschutz Medical Campus and one of the investigators of Study 1620 (NCT03132636), on which the approval was based, spe...
The FDA has approved cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.), a programmed cell death protein 1 (PD-1) inhibitor, for the first-line treatment of patients with advanced non-small lung cancer cell (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in at least 50% of their cells and whose tumors do not have aberrations in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or C-ROS oncogene 1 (ROS1). "An estimated 25% to 35% of advanced NSCLC ...
Today, AstraZeneca voluntarily withdrew the indication of durvalumab (Imfinzi®, AstraZeneca) for patients with previously treated locally advanced or metastatic urothelial carcinoma based on results of the phase 3 DANUBE trial (NCT02516241), which did not meet its primary end points. The withdrawal does not affect durvalumab's indications for non-small cell lung cancer or for extensive stage small-cell lung cancer. Durvalumab, a human monoclonal antibody that binds to programmed death ligand 1 (...
The FDA has approved trilaciclib (CoselaTM, G1 Therapeutics) for the prevention of myelosuppression in patients receiving chemotherapy for extensive-stage small-cell lung cancer (SCLC). Occurring when chemotherapy agents damage the bone marrow, myelosuppression decreases the production of red blood cells, white blood cells, and platelets, causing patients to experience fatigue, bleeding, and increased risk of infection. "Chemotherapy is a mainstay of cancer treatment; however, its side effects, ...
Recently, the FDA approved subcutaneous daratumumab in combination with bortezomib/cyclophosphamide/dexamethasone (VCd) for the treatment of patients with newly diagnosed amyloid light chain (AL) amyloidosis. In this interview, Efstathios Kastritis, MD, Associate Professor of Clinical Therapeutics at the National and Kapodistrian University of Athens and senior author of ANDROMEDA (NCT03201965), the study on which the approval was based, discusses the challenges of treating patients with AL...