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:


grayconnections said...


A bit of clarification:
Xalkori has not been fast-tracked for ROS1-positive lung cancer--Pfizer, the drug's manufacturer, hasn't applied to the FDA for any approvals of Xalkori related to ROS1.

However, Xalkori IS an FDA-approved drug for ALK-positive non-small cell lung cancer, and a previous journal article showed Xalkori produced amazingly good preliminary response in ROS1-positive NSCLC patients. So, oncologists are prescribing Xalkori for ROS1 "off label," and most insurance plans are covering it.

Luna O. said...

Thanks for the clarification. Between you and Tori, I think I have it straight now. I'm not sure what I've been reading and how I misunderstood the details. I didn't realize Xalkori for ROS1 was an off-label use.