Zandelisib joins umbralisib in the parade of PI3K inhibitors that won’t be developed as an option for chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL / SLL) patients that have run out of options.
This is especially discouraging because MEI Pharma had come up with a unique intermittent dosing schedule that seemed in early trials to significantly mitigate the serious side effects of this class of medications. Unfortunately, we will never know if the new molecule and the new dosing protocol will work.
The official company press release clearly presents why they are deciding to discontinue their American trials.
“The discontinuation of zandelisib development outside of Japan is a business decision based on the most recent regulatory guidance from the FDA and is not related to the zandelisib clinical data generated to date.”
It is already hard to get new cancer drugs approved in general by the FDA, and now it is especially hard for PI3K inhibitors because of their real toxicity.
We remain grateful the FDA is watching out for our safety but have to wonder if there is a way to protect patients and not dampen drug development.
We need our drugs to be safe, but we also need more options.
Stay strong. We are all in this together.
Brian Koffman MDCM (retired) MS Ed (he, him, his)
Co-Founder, Executive VP, and Chief Medical Officer