Gilead Sciences continues to invest in the drug originally known as CAL-101 and now known as idelalisib. Gilead acquired this drug along with the rest of Calistoga Pharmaceuticals back in 2011. Clinical trial data for both CLL and non-Hodgkin’s lymphoma look good, and the FDA is scheduled to complete a priority review of Gilead’s New Drug Application for CLL by early August and for NHL by early September.
There are 11 clinical trials currently open and recruiting new patients. Importantly (and congratulations to Gilead for doing the right thing!) there is an expanded access program for patients with relapsed, previously-treated CLL who are not eligible for other Gilead clinical trials. The expanded access protocol provides for idelalisib to be used in combination with rituximab.
Although for some patients, diarrhea is a serious side effect, for many people it is not severe and can be controlled with other medication. In general, this is a much milder drug than many options that people with cancer must choose from, and the efficacy results some patients have experienced is quite dramatic.
Of note is a mouse study recently published in the scientific journal “Nature.” It turns out that, in mice at least, this drug works rather well against solid tumors. Earlier in the drug’s development, the expectation was that it would be limited to use primarily against leukemias and lymphomas rather than solid tumors. It will be a while before human clinical trials test the usefulness of this new drug against solid tumors, but it’s certainly worth watching and keeping in mind as more data become available.