Update on Epcoritamab

A quick update on Epcoritamab.

Epcoritamab is a bispecific antibody. I wrote about it less than 2 weeks ago in an ASH preview. I'm predicting that it will be the Follicular Lymphoma presentation that gets the most attention during and after the ASH conference.

Here's some attention before the conference as well:

The makers of Epcoritamab got some good news this week from the U.S. and from Europe.

The European Medicines Agency granted Epcoritamab a validation for a type 2 application for Relapsed/Refractory FL patients with at least two prior treatments.  The EMA is kind of European equivalent of the FDA, approving treatments before they are available to patients outside of clinical trials. A type 2 variance, as I understand it, includes things like expanding the use of an approved treatment. Epcoritamab was approved a few months ago as a treatment for R/R Diffuse Large B Cell Lymphoma.

In addition, the FDA has granted Breakthrough Therapy Designation for  Epcoritamab. This means that it will get a faster review than it would otherwise, because approval would mean a significant improvement in treatment options for patients with FL.

To be clear -- neither one of the agencies has granted a new approval for Epcoritamab for R/R Follicular Lymphoma. These are positive steps in the process. Both agencies will now take a closer look at the data, including the updated data to be presented at ASH, in determining whether or not to approve the treatment. 

That's good news for all of us.