Thursday, October 10, 2013

Idelalisib / CAL-101 / GS-1101 News

Big news yesterday from Gilead, the maker of Idelalisib (also known as CAL-101 and GS-1101). It's not related to Idelalisib as a treatment for Follicular Lymphoma, but I think it's exciting and significant anyway.

Gilead announced that their phase 3 trial for Idelalisib in Chronic Lymphocytic Leukemia (CLL) patients will be stopped because it's going so well.

CLL is similar in some ways to Follicular Lymphoma, on that it affects B cells, and is generally slow-growing (in fact, while CLL is considered a leukemia, SLL, which is essentially the same disease but shows up differently, is considered an indolent lymphoma. To-may-toe, to-mah-toe.

As for the study, it focused on patients who had previously been treated, but were not good candidates for chemotherapy. Idelalisib, with fewer side effects, can be handled better than traditional chemo.

In the study, half of the patients received Idelalisib, and the other half received Rituxan. The preliminary results were so good, in terms of progression-free survival and safety, that Gilead was advised to stop the study. The advice came from an independent organization, not the FDA. The next step is for Gilead to negotiate with the FDA to see if they can get approval for Idelalisib. Maybe that will happen; maybe the FDA will ask that the study be continued.(I don't know if Gilead is considering that possibility, though they are continuing to treat the patients who are receiving Idelalisib).

From what I know of the FDA process (and I'm no expert), it seems like a slightly risky maneuver. There's no guarantee that they get early FDA approval. on the other hand, it seems like they could get conditional approval, and be asked to continue the study -- not so bad, either. They have a couple of things on their side: an independent agency making the recommendation, and the fact that there really isn't anything else out there for CLL patients who can't do traditional chemo. 

So why am I so excited about this, given that it isn't about Follicular Lymphoma?

Well, I'm excited because Idelalisib seems so promising for us -- it is in trials for Follicular Lymphoma as well, and looking good. Of course, despite the similarities between FL and CLL, they are totally different cancers, and nothing that helps one is guaranteed to help the other. But I feel good knowing that Idelalisib works for other cancers, too. Makes it seem more like the mechanism is really understood.

The other thing that seems exciting to me is that the FDA seems to be loosening up on its process a little. Not that I want them to approve things that aren't proven effective or safe, but I like the idea that they recognize that some results are just so good, and will be so helpful, that they are worth approving early. I like the idea that the FDA could consider something like that in the future for a promising Follicular Lymphoma treatment.

So, we can't pronounce Idelalisib as another arrow in the quiver just yet. But maybe the guy standing next to us at the archery range will get one soon, and we can at least shake his hand and feel good about that.

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