Woohoo! My clinical trial drug may get FDA approval soon! It’s about time.
The clinical trial in which I participate has been running for over three years. I take Xalkori (crizotinib) for my ROS1-positive non-small cell lung cancer. Early phase clinical trial results announced last year show around 72% of patients experienced measurable shrinkage of their tumors, and another 12% achieved stability. This is remarkable, considering most chemos have a response rate around 20%.
The average crizotinib response lasted about 17 months, with half of the patients still responding when the data was collected for the journal article. I personally know at least four people (including me) who responses have lasted over two years (two of them are not on the trial).
Today Pfizer announced it had received US FDA “breakthrough” designation for Xalkori treatment of ROS1+ non-small cell lung cancer. This means it is on the fast track for FDA approval for treatment of ROS1 NSCLC (after already being approved for treatment of a different lung cancer mutation).
My marvelous clinical trial drug may finally get FDA approval. It’s sort of moot, in a way, because the evidence of its effectiveness is so outstanding that most US insurance companies are already paying for crizotinib treatment of ROS1 NSCLC. But it is still cool.
Coincidentally, I have my clinical trial appointment today, and I’ll be talking with one of the lead investigators (my oncologist, Dr. Ross Camidge) about what this announcement means for those of us still on the trial.