Pembrolizumab (Keytruda®, Merck) has received accelerated FDA approval for patients with metastatic small cell lung cancer (SCLC) experiencing disease progression during or after platinum-based chemotherapy following at least one other previous line of therapy. Metastatic SCLC, or extensive-stage SCLC, comprises around 15% of all lung cancers and occurs primarily in heavy smokers. It carries a dismal outlook; only 5% of patients with extensive-stage SCLC live for two years after diagnosis. Appro...

Recently, the FDA approved ruxolitinib (Jakafi®, Incyte Corporation), a JAK1/JAK2 inhibitor, for the treatment of steroid-refractory acute graft-versus-host disease (GVHD). A potentially life-threatening condition, GVHD is a complication of allogeneic hematopoietic stem cell transplantation (HSCT), a treatment for hematologic malignancies that is administered following high-intensity chemotherapy or radiation. In this interview with i3 Health, Corey S. Cutler, MD, MPH, FRCPC, Medical Director of...

Pembrolizumab (Keytruda®, Merck) is now approved by the FDA for head and neck squamous cell carcinoma as first-line treatment in combination with platinum and 5-fluorouracil. Pembrolizumab is already FDA approved to treat advanced non-small cell lung cancer, advanced urothelial bladder cancer, classical Hodgkin lymphoma, primary mediastinal B-cell lymphoma, and many other cancers. This immunotherapy drug inhibits programmed cell death protein 1 (PD-1) in order to increase the body's ability to a...

The FDA has now granted accelerated approval to polatuzumab vedotin (Polivy®, Genentech, Inc.) in combination with bendamustine and a rituximab product for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, following two or more prior lines of therapy. Estimates of five-year survival for DLBCL have been reported at 62.0% in the United States and 55.4% in Europe. Over 50% of patients with advanced-stage, previously untreated DLBCL experience complet...

As part of a pilot program intended to aid oncology health care professionals in requesting Expanded Access, which makes investigational treatments available to certain patients with cancer, the FDA has announced the creation of Project Facilitate, a call center to aid physicians in the process of submitting Expanded Access requests for individual patients. "Through this pilot program, experienced FDA oncology staff will be available to support physicians and other health care professionals with...