Some Treatment Approvals outside the U.S.

I've said more than a few times that I know my perspective on Follicular Lymphoma is very much an American one. I tend to focus on treatment approvals by the FDA in the United States, and write about issues that affect Amercan patients. Which makes sense, of course, since I live in the U.S.

But I also try to keep up with things that are happening outside my country when I can. I have readers from about 80 different countries, according to my Google analytics. I want to provide relevant information to as many of you as I can.

So here's some news from the last couple of weeks that may excite some you.

EU approves Odronextamab

First, the European Commission has approved Odronextamab for patients with relapsed or refractory Follicualr Lymphoma who have had at least two prior treatments. 

If you've been reading the blog lately, you know that Odronextamab is a bispecific antibody, a type of treatment that many oncologists are excited about. You also know that there was some slightly revised data published recently from the clinical trial that was used to approve the treatment. And you also know that in the U.S., the FDA denied approval (delayed approval, really) for Odronextamab a few months ago because they wanted to see more data from a larger trial. So you folks in Europe have access to this sooner than those of us in the U.S.

EU Approves Epcoritamab

The EC also granted "granted conditional marketing authorization" for the expanded use Epcoritamab for patients with relapsed or refractory FL who have had two or more treatments. Epcoritamab is also a bispecific antibody. It was approved by the EC for Diffuse Large B Cell Lymphoma, so this approval makes it "expanded use." The "conditional" part of the approval seems to come from a planned study that the makers of the treatment will conduct to try to cut down on Cytokine Release Syndrome. But the treatment is now available. 

Epcoritamab was approved by the FDA about two months ago. So it looks like we have a draw, as far as whether Europe and the U.S. approved a bispecific before the other. We may need to go to a shootout.

(See? A Football comparison. I can write for non-U.S. audiences. I didn't even call it Soccer.)

EU Approves Liso-Cel

Finally, the European Medicines Agency approved a Type II variation application for Liso-Cel (also known as Breyanzi) for r/r FL patients with at least two prior treatments.Liso-Cel is a CAR-T treatment. Before I get into the FDA approval, it might be important to know what a Type II variation is. Then we can determine who won this football/soccer match....

But wait. What's this? Japan is on the pitch!

Japan's Ministry of Health, Labor, and Welfare has also approved Liso-Cel for r/r FL patients, but with only one prior treatment, not two. 

This changes everything! We have to sort this out before we can determine a winner of this match! I'll need to get back to you!

That was silly, I know. But truly, the winners are all of the thousands of r/r FL patients in many countries who now have access to the some of the treatments that are most exciting these days. Expanded options are good for all of us. 

And while many FL patients have relapsed or refractory disease after two treatments -- and those are probably the patients who need treatment options the most -- some of us have r/r disease and just one treatment, and others are still benefiting from their first, or have yet to receive treatment. So I hope there are more approvals coming soon that I can share with you. 

That would be some World Cup-level stuff.

 

Liso-cel

https://www.cancernetwork.com/view/ema-validates-type-ii-application-for-liso-cel-in-r-r-follicular-lymphoma