Friday, May 20, 2011

A Paradigm Shift in How Cancer is Evaluated and Treated

We all know there are many different cancers (lung, breast, ovarian, etc.). We have also heard that within similar cancers there are cancer subtypes. If one goes to a cancer website (e.g., the American Cancer Society at, it is generally organized by cancer type. Same with medical institutions... lymphomas, lung, bone, breast, etc.

There is a lot of buzz right now for a recent Pfizer drug, Crizotinib, in the fight against lung cancer. Pfizer has isolated a genetic mutation in a human gene known as ALK. It is estimated that 3 to 5% of those with lung cancer have this genetic mutation. Although that's not a large percentage, it's estimated to be 7,000 to 10,000 new cases of lung cancer (out of 220,000) in the U.S. per year. Crizotinib targets this genetic mutation leaving healthy cells alone. In an early trial with 82 patients there was measurable tumor shrinkage in 90% of patients after two months. This compares to an expected response rate closer to 10%. This genetic mutation was identified in 2007. Pfizer is requesting an accelerated approval from the FDA and expects it to be granted this year. The drug, if successful, could be FDA approved by as early as 2012. This would reduce the time of drug development from 8 to 10 years to five years. My hat is off to Pfizer and all those who participated in this discovery and development.

Now for the paradigm shift. What other cancers have this ALK mutation? Head and Neck cancer, Breast cancer, Liver cancer, Ovarian cancer, and the list goes on. An assay for the detection of this ALK mutation is a few hundred dollars. As an early step in a patient's cancer assessment process, would it not make sense to test for an ALK mutation?  And, in cases where there is an ALK mutation, would it not make sense to give the patient a choice as to joining a clinical trial for the use of Crizotinib? This would mean crossing organizational boundaries within established medical institutions. Within the best medical institutions, this will not be a roadblock.

For more information, Google Crizotinib. It has been written up in the Wall Street Journal, USA Today, various oncology-oriented publications and by Pfizer. This is truly an exciting development in the war on cancer.

Take car everyone.