The FDA granted accelerated approval to Epcoritamab for Relapsed/Refractory Follicualr Lymphoma yesterday.
The approval is for Relapsed/Refractory disease after two previous lines of treatment.
Epcoritamab is a bispecific antibody. Like all bispecifics, it works in two parts. It attached itself to cancerous B cells (the way Rituxan works) but also attaches itself to a T cell, allowing that immune cell to work on the cancer cell. This will be the second bispecific available to at least some FL patients.
The treatment got a lot of attention at ASCO a few weeks ago, and any concerns about safety were addressed in particular. That said, there will still be a warning on the box for "serious or fatal cytokine release syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity (ICANS)." This will be a standard warning, not a more serious "black box" warning.
The apprval is based on Epcoritamab's very good effectiveness. In the clinical trial that provided data for the approval, the Overall Response Rate was 82%, with a Complete Response of 60%. The median Duration of Response after 14.8 months was not yet reached, meaning more than half of the 127 patients in the study were still getting a response after that time.
This is, of course, good news for all of us. Another arrow in the quiver, as one of my oncologists used to say.
More to come.
No comments:
Post a Comment