An FDA panel recommended the approval of biosimilars for two top-selling cancer drugs. Specifically, the panel unanimously backed approval of biosimilars for Avastin (six of its current indications) and Herceptin (all of its indications).
CAR T-cell therapy
An FDA panel unanimously recommended approval of a treatment developed by Novartis and the University of Pennsylvania that reengineers a patient's own cells to combat a type of leukemia.
If approved, it would be the first-ever gene therapy to come to the U.S. market.
What does this news mean for cancer programs? Here's what I told the Daily Briefing:
The FDA panel's recommendation to approve CAR T-cell therapy marks an exciting step forward for cancer treatment. The immediate impact of an approval would be limited to a small number of patients receiving care at select organizations, but cancer providers, researchers, drug manufacturers, and patients across the country are betting big on the promise of these new therapies, particularly immunotherapy and targeted treatments.
Because of the excitement around these innovations, providers across the country are understandably eager to deliver them to their patients. However, leaders need to be strategic in their investments, as the field is rapidly evolving and there are still many unknowns. To help physicians put precision medicine into practice, leaders need to invest in clinical decision support tools and ongoing opportunities for education and expert collaboration, such as molecular tumor boards.
In addition, many of these new therapies come with severe side effects that are not yet well understood. Another CAR T-cell therapy trial was halted last year due to five patient deaths, and studies have shown that 30 percent of patients on checkpoint inhibitors (a more common form of immunotherapy) experience "interesting, rare, or unexpected side effects." In response, we're seeing progressive organizations, such as Avera Cancer Institute and Intermountain Healthcare, develop dedicated precision medicine clinics. These serve as on-demand resources for patients who are interested in learning more about their treatment options and for providers who benefit from ongoing symptom management support for patients on these new therapies.
Read the full Daily Briefing article to learn more about the new developments.