FDA Approval for R-Squared

I know I promised ASCO stuff over a week ago (the conference started today). But there was some news today from the FDA that needs to be shared:

R-Squared has been approved for previously-treated Follicular Lymphoma (and Marginal Zone Lymphoma, but that's not the focus here).

R-Squared is, of course, a combination of Rituxan and Lenalidomide (also known as Revlimid). I've been reading about it for years, and seeing the excitement from researchers has been very cool.

It's always been a big deal because it's a non-chemotherapy option that works as well or better than chemo.

The approval comes from two clinical trials. The AUGMENT trial compared R-Squared with Rituxan. The median Progression-Free Survival for R2 was 39.4 months, with an 80% response rate, versus 14.1 months for Rituxan, with a 55% response rate.

The second trial was called MAGNIFY, and it did not have a direct comparison between R2 and another treatment. The response rate in this trial was 59%.

In the two trials combined, at least 20% of patients had side effects including neutropenia, fatigue, diarrhea, constipation, nausea, and cough. There is also a "Boxed Warning" (the most serious warning from the FDA) about the risk of embryo-fetal toxicity, hematologic toxicity, and venous and arterial thromboembolism, all of which could be fatal (but which are rare).

This approval is for patients who already had treatment. There is still the possibility that untreated patients might get R-Squared approval, too, based on the RELEVANCE trial. Still waiting for an application for FDA approval for untreated FL though there are some concerns to deal with before that happens.

But for now, this is excellent news. Another arrow in the quiver -- another option for FL patients.

Back to ASCO soon. The press releases for any Big News should be showing up starting tomorrow.