FDA approves CAR T-cell therapy to treat adults with certain types of large B-cell lymphoma. The FDA approved a cell-based gene therapy known as Yescarta (axicabtagene ciloleucel) to treat adult patients with certain types of non-Hodgkin lymphoma. Yescarta is intended for patients who have failed at least 2 other cancer therapies. The new treatment has a boxed warning for cytokine release syndrome (CRS) — a significant inflammatory response — and for neurologic toxicities, which can be fatal or life-threatening. Yescarta was approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). This means that centers that administer the treatment need to be trained and certified to manage the potential for CRS and neurologic toxicities. Posted October 18, 2017. Via FDA.
FDA approves first biosimilar for the treatment of cancer. The FDA approved Mvasi as a biosimilar to Avastin (bevacizumab) for the treatment of certain colorectal, lung, brain, kidney and cervical cancers. A biosimilar is a biologic medication that is considered interchangeable with a brand-name biologic and is not significantly different in terms of safety and effectiveness. They also tended to be drastically cheaper.
Some serious side effects associated with Mvasi — as well as Avastin — blood clot formation, hypertension, problems in brain function or structure, and ovarian failure. Mvasi, like Avastin, also contains a boxed warning about an increased risk of holes in the stomach and intestines, potential complications in healing from surgery and an increased risk of hemorrhaging in various parts of the body. Posted September 14, 2017. Via FDA.