European Approval Application for Odronextamab

I'm about a month late with this news, but the makers of the bi-specific Odronextamab applied for approval with the European Medicines Agency (EMA) in August.

As I've said before, I'm trying to pay more attention to what's happening with Follicular Lymphoma outside of the USA, since so many of my readers are from other parts of the world. And since Odronextamab is a bi-specific, one of the more exciting types of treatments available to FL patients, it's definitely news worth sharing. 

Odronextamab had already been given Orphan Designation by the EMA. "Orphan Designation" is a particular program for the EMA (the FDA has something very similar). It's a program that focuses on treatments for rare diseases, and provides incentives for manufacturers to develop these treatments. It makes sense -- if a drug maker can use it's time and resources for a treatment for high blood pressure or diabetes, something that affects millions of people, they can make billions of dollars every year on an effective treatment. But that means there is little incentive to spend those same resources on a treatment for a rare disease that might only affect a few thousand people every year. Orphan Designation gives them a reason to focus on those potentially less profitable diseases. 

So after Odronextamab got the Orphan Designation and went through some trials, they had good results. As a bi-specific, the treatment targets the CD20 protein on a cancer cell and the CD3 protein on a T cell (an immune cell) and brings them together so the immune cell can take out the cancer cell. 

The application is based on the results of phase 1 and phase 2 clinical trials that were presented at the ASH conference last December. Effectiveness was great -- 82% Overall Response Rate with a 75% Complete Response Rate.

However, as I noted in that link above, there were also some serious safety concerns with the treatment. Apparently, newer data, or something else in the application, has made the EMA feel better about those concerns (it's unlikely that the maker would make the application if there wasn't a good chance that it would be accepted. That Orphan Designation might have been a big help, given them some extra attention by the EMA during the application process). 

As far as I know, the maker hasn't applied to the FDA yet for approval in the USA. They may be waiting to see how things go with the EMA.

The EMA says it can take about 7 months for an application to be reviewed, so it might be a while before we hear more news about this one. In the meantime, I hope there is some updated information presented at ASH in December. If it is approved, it would be available in all European Union (EU) member states, Iceland, Norway and Liechtenstein. 

(I don't think I have any readers in Liechtenstein, which is a shame. I visited there once, years ago, and went to nice restaurant where I ate an ostrich steak. It was a memorable night. If there's anyone out there from Liechtenstein, please say hello in the comments.)

I'll keep you updated on all of this.