Saturday, September 27, 2014
New England Journal of Medicine: ROS1 Mutations and Crizotinib (Xalkori) - Phase 1 Data
Today I received an email from my oncologist about the phase 1 clinical trial data for lung cancer patients with ROS1 mutations who are on crizotinib, (Xalkori.) The article and data were just published in the New England Journal of Medicine.
I knew that Xalkori was fast tracked by the FDA for patients with ROS1 mutations, which means it was released for use prior to the completion of the clinical trials. The FDA sometimes does this because trial participants are doing so well on the drug and there's previous reassuring data for its use from some other study. What I didn't understand is that it was released prior to the completion of phase 1. (There are usually three phases of a clinical trial before a medication is approved by the FDA.)
In any case, for those interested, it's an interesting article: