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My drug is a breakthrough!

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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.

Pfizer Receives U.S. FDA Breakthrough Therapy Designation For XALKORI® (crizotinib) For The Treatment Of Patients With ROS1-Positive Non-Small Cell Lung Cancer

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.

Clinical Trial Check-In Number 18

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Denver gifted me with a warm, bright day today — clear skies, 60 degrees, a hint of breeze — perfect for sitting on a sun-drenched bench and basking in the glow of another clean scan. I’m still No Evidence of Disease (NED) status. Woohoo!

You’d think I would have had enough radiation for one week, but that spring sunshine was simply irresistible after such a long winter.

I had a PET-CT scan as well as a brain MRI and lab work yesterday, and had my once-every-eight-weeks visit with my clinical trial oncologist Dr. Camidge at University of Colorado this afternoon. Today I started cycle 19 on the drug Xalkori. Each cycle is 4 weeks, so I’ve been on this drug trial for 76 weeks now, which is almost 17 months.

I’ve been NED for nearly 15 months on Xalkori. According to interim results published about this clinical trial last year, only myself and one other person achieved NED on this trial. It’s possible I don’t have many cancer cells available to mutate and develop resistance to the drug. My particular flavor of lung cancer (ROS1-driven NSCLC) hasn’t been studied very long — the first article about it was published in January 2012 — so little data exists to know what will happen in my case. Xalkori may continue to suppress my cancer for years. It’s cool to hear my doctors say they have no idea of how long I might have left, and know they’re being honest with me. I’m an outlier for those gloomy stage IV lung cancer statistics.

I feel so fortunate to be blessed with more time to enjoy family and the miracle of life. I aim to make good use of it.

Speaking of making good use of my time … should I mention I have to work on tax returns after I fly home? Nah.