Yesterday, the FDA announced that it has granted accelerated approval for Ibrutinib for Mantle Cell Lymphoma.
The accelerated designation came because the approval was based on results from a phase 2 clinical trial, rather than the usual phase 3 trial, which would have involved a wider pool patients. The results were certainly impressive: a 68% overall response rate, with 21% achieving a complete response. The response was decently long-lasting, with a median of 17.5 months.
Ibrutinib is a kinase inhibitor, a funky new class of treatments that targets kinases, which are enzymes that act to do things like phosphorylation, which is a process that I don't feel like looking up right now and describing. Let's just say that kinases work to make some complex things happen within cells, including some that encourage the growth of cancer. A kinases inhibitor like Ibrutinib stops those things from happening. (What more do you need to know?)
Ibrutinib is still not approved for Follicular Lymphoma, though a trial is currently under way that looks at Ibrutinib in Follicular Lymphoma patients who had already received a different treatment. Another small study showed that Ibrutinib works very well with R-CHOP, achieving a 100% response rate in 15 patients. I think there are others, too. As far as I can tell, there's nothing at ASH this year reporting on any Ibrutinib studies for Follicular Lymphoma.
So, not directly good news for Follicular Lymphoma, but I like hearing that treatment under consideration for FL is doing well elsewhere. There's no guarantee it will work for Follicular Lymphoma, of course, but I still like to hear those success stories.
More ASH stuff coming up.
Bruton's tyrosine kinase (BTK) inhibitor