FDA Priority Review for R-Squared

The FDA has announced that it will grant Priority Review to R-Squared, the combination of Rituxan and Revlimid (also known as Lenalidomide) for patients with previously treated Follicular Lymphoma.

Priority Review means the FDA will review the application sooner than normal. It should take 6 months, instead of the usual 10 months. Priority Review is granted when the FDA thinks the treatment has the potential for "significant improvements" over current treatments, because it is more effective, or safer, or both.

The application includes data that was presented at the ASH meeting in December. They compared R-Squared to Rituxan in patients that had already had treatment. R-Squared patients had a longer Progression Free Survival (39.4 months, vs. 14.1 months for the Rituxan groups). The R-Squared group also had a higher Overall Response Rate (78% vs. 53%) and a longer duration of response (36.6 months vs. 21.7 months).


It's really strange to see R-Squared finally going up for FDA approval. I've been reading and writing about it for so long, it seems like it should have already been approved. I did a quick search of this blog, and the first time I mentioned Revlimid was in March 2008 -- 11 years ago, just two months after I was diagnosed. Honestly, I didn't think I was even writing about treatments back then. i'm surprised to learn that I've been a Cancer Nerd even longer than I thought. the first time I wrote about the R-Squared combination was in May 2010.

And for almost that long, researchers have been excited about the possibility.

So I'm glad we're finally getting around to an FDA review. That's good.

An interesting side lesson here. It's a good reminder that approvals take a long time. An early trial with good results is something worth being hopeful about, but not too excited about. These things can take years to happen. On the other hand, if something isn't approved right away, that's OK -- as long as good results keep coming, something might be worth the wait.