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.
Many patients with active cancer can fly safely. If you have concerns about your fitness for flying, ask your doctor — some cancer patients (such as those who have had lung-related problems, edema, or recent surgery) might be at risk for complications if they fly. Cancer Research UK’s brief list addresses situations when you shouldn’t fly. The National Comprehensive Cancer Network’s online article offers general tips about traveling with cancer. However, even though you and your doctor think you can fly safely, sometimes the airline might prevent you from flying … continue reading
Photo credit: Flickr user Francesco (Creative Commons)
Today I’m again boarding a flight to Denver, Colorado, for my bi-monthly scan and clinical trial check-in. Packing and traveling for my clinical trial is pretty routine after 2+ years. Despite the best effort of my conscious mind and having No Evidence of Disease for 28 months, some small part of me still gets nervous as scan time approaches. Even seasoned cancer survivors can sometimes experience scanxiety.
Perhaps spending March dealing with pneumonia prompted this feeling. I caught an upper respiratory virus shortly after my husband did. Since I could see his symptoms were similar to mine, and my symptoms started only a few days after my last clean scan, I wasn’t worried the severe goopy cough might be lung cancer progression. However, the goop got caught in my radiation-scarred lower lobe of my left lung, and set up residence. It took me two Z-paks of antibiotics and a couple of extra weeks to knock it out.
I suppose that reminder that my lungs are vulnerable could be enough to explain my edginess and need for more hugs. It’s not overwhelming, it just slows me down a bit. I just wish my rational mind and faith had learned by now how to silence the vague unease.
Fortunately, a new science fiction story idea popped into my head yesterday and is vigorously trying to elbow out an article I’m struggling to finish this week. I’ll try to capture the concept on my flight to my Denver clinical trial today, before it fades in the chemobrain fog. My mind will be productively preoccupied during this trip. Maybe if they work together, the two writing projects can throttle this low-level scanxiety.
Distraction is the better part of valor.