Priority Review for Mosunetuzumab

Just a quick one today:

The FDA has granted Priority Review for Mosunetuzumab (also known as Lunsumio). As you probably know, Mosunetuzumab is a bi-specific.

You can read a little more about Mosunetuzumab here, when I wrote it about last month. There was an ASCO presentation about it, with some updated numbers from the phase II clinical trial, and some news about the EU approving it for Follicular Lymphoma patients who have already had at least two treatments, and are relapsed or refractory (that is, their last treatment didn't work, or has stopped working).

As I wrote last month, the numbers for Mosunetuzumab are great. The Complete Response Rate was 60% and the Overall Response was 80% after a follow-up of 18 months. The median duration of response was 22.8 months -- very strong numbers when compared to other recently approved treatments.

Priority Review means that Mosunetuzumab kind of skips ahead of the line a little bit. They should have a decision before the end of 2022.

It will be interesting to see how the FDA handles this, in light of all of the problems that happened after the PI3K Inhibitor disaster from earlier this year. All of those inhibitors were approved based on phase 2 clinical trials, which is smaller than the usual phase 3, and come much quicker. The additional time that it takes for a phase 3 trial also means that researchers can see longer term results from the patients in the phase 2 trial -- including longer term side effects that might not have shown up right away. I'm not sure if the FDA is a little more skeptical about all trials, or just those from PI3K Inhibitors. They did grant Priority Review, so they must feel OK about the shorter time. Bi-specifics and Inhibitors are pretty different treatments, so the issues that concerned them might not be as worrisome for Mosunetuzumab.

I'm always a little excited about potential new treatments, and especially this one, because my current oncologist suggested it might be a good one for me if/when I need treatment again, back when it was still in its phase 1 trial. (Remember, it's good to ask your oncologist about nearby trials that might be appropriate for you. It's the only way we'll get newer, better treatments).

But I also know that the approval process can be slow, and slower is better with cancer treatment approvals, no matter how excited we are about them.

I have a few more bits of Follicular Lymphoma news to share. I'll get to them soon.