Another FDA Approval for Follicular Lymphoma: Copanlisib

The big Follicular Lymphoma news from the weekend was the FDA's approval of Copanlisib, also known as Aliqopa, for relapsed FL.

Copanlisib is a type of kinase inhibitor. Like other inhibitors, it doesn't work by directly killing a cancer cell, the way traditional chemotherapy does. Instead, it works by stopping (or inhibiting) a process that keeps the cancer cells alive.

In this case, Copanlisib stops an enzyme that is part of a long chain called the PI3K/AKT/mTOR pathway. In that pathway, a bunch of reactions happen -- an enzyme tells a protein to tell something else that something needs to happen for the cell to grow, or divide, or just stay alive. there are other treatments that target different parts of the pathway, but Copanlisib targets that first part, the PI3K part. Idelalisib is another PI3K kinase inhibitor -- it's a good one to target for Follicular Lymphoma. There are least two other kinase inhibitors being developed for FL.

Copanlisib was given accelerated approval by the FDA, which means it went through the approval process quicker than it normally would. It also means that the approval isn't complete yet. The approval was given based on a phase II clinical trial, that showed good results on a smaller patient population. A phase III trial will need to confirm that Copanlisib is as good as it seems.

The approval is also for a fairly narrow group -- Follicular Lymphoma patients who have relapsed, and who have had at least two prior systemic treatments (a treatment that involves the entire body or "system" -- something like chemotherapy).

The approval points out that many patients who have this kind of treatment history are having a hard time finding something that works, and Copanlisib does seem to work for a lot of them. That phase II trial found that Follicular Lymphoma patients in the study had a 59% Overall Response rate, with a median response of just over a year. Pretty good when you're having trouble finding something that works, and unfortunately, there are a lot of folks in that position.

Of course, there are side effects. Some of them are common in lymphoma treatments -- since they go after immune cells, the side effects involve different types of lowered immunity. But Copanlisib also has some other different side effects, like hyperglycemia, or high blood sugar. Copanlisib effects an enzyme that is involved in insulin production, so the body doesn't process blood sugar as efficiently as it should.

So we have another arrow in the quiver -- another treatment that can be used if the situation is right. That's always good news.

In addition to the phase III trial that will confirm that the approval was justified, there is at least one other trial involving Copanlisib for FL. This one combines it with immunochemotherapy (R-CHOP or R-Bendamustine). Lots of treatments these days seem to work better as a combination with other treatments, so it makes sense that this is being explored.

Lots to look forward to -- potential treatments that could help us all in the future.

(This is a good time to remind you all that treatments can't be studied and approved with people joining clinical trials. So if you are in the unfortunate position of needing treatment, talk to your doctor about clinical trials that might be appropriate -- check here to learn more.)