Treatment Approval News

There have been a few announcements in the last couple of weeks related to treatment approvals by the FDA and other regulatory bodies. I thought I'd give you a summary here. 

First, in my latest attempt to provide FL news from outside the United States: The Ministry of Health, Labour, and Welfare in Japan has approved Epcoritamab for Relapsed or Refractory Follicular Lymphoma. Epcoritamab is a bispecific, and the approval came from the results of the EPCORE NHL-1 clinical trial, which was conducted in 15 countries. Epcoritamab was approved in the U.S. last June. I don't hear a lot about Folllicular Lymphoma is Japan, which is too bad. My youngest child studied in Japan for four months, so I've learned about the country and culture. Looks like a great place to visit someday. It's always great to have another treatment available to people, no matter where they are. 

Second bit of news: The FDA has approved a generic version of Lenalidomide (Revlemid).  Lenalidomide is best known to patients with FL as half of the R-Squared combination (along with Rituxan). But it was first approved in the U.S. in 2005, and is now used to treat several different blood cancers. This approval is for capsules in different strengths, from 2.5 mg to 25 mg. (Studies on FL patients are usually at 20mg, though dosages can be different for different patients). In theory, a generic version of a treatment means the cost will come down, since the original developer has had time to recoup the costs of research and marketing and take some profit. We shall see. The new generic version should be available in January 2026.

Finally, The FDA has accepted the resubmission of the Biologics License Application (BLA) for  Odronextamab for Relapsed/Refractory FL. Odronextamab is another bispecific. It was approved by the European Commission in August 2024, but the FDA was more cautious. The makers of Odronextamab had submitted data from a phase 2 clinical trial, but the FDA wanted to see data from a larger phase 3 trial. It did not reject the Odronextamab application based on effectiveness or safety, but only because it wanted to see more data. So they now have that data. It will be interesting to see what comes of this. My guess is that it will be approved, but there were some concerns about side effects in the initial trials (about 16% of patients had to drop out of the trial because of severe side effects. This application will have more data on that, and the FDA can make a decision based on it all. 

I'll certainly keep an eye out for news about the Odronextamab application, and any other treatment approval news that affects us as FL patients.