Dear Commissioner Hamburg,
Thank you considering lung cancer as one of the priority diseases to be considered for the new patient-focused drug development initiative.
The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated to the study of lung cancer. It’s our mission to use all available means to eliminate lung cancer and other thoracic malignancies. As scientists and experts in lung cancer from all over the world, we see the damage lung cancer causes. For too long, people with lung cancer have been without cures, treatments and too often, hope.
Lung cancer meets this new patient-focused drug development initiative's criteria because lung cancer is the #1 cancer killer of both men and women in the United States, claiming more than 160,000 victims each year in the U.S. alone. Lung cancer is responsible for 29 percent of cancer deaths in the U.S. And, each year more than 226,000 new cases are diagnosed, but lung cancer 5-year survival rates remain at just 15 percent.
We now recognize that lung cancer is a very heterogeneous disease with many identifiable "driver" molecular changes that can be targeted by novel drugs. Several such targeted tyrosine kinase inhibitors have recently been approved but many of the target abnormalities that occur in only about 1 percent of lung cancers. And the approved tyrosine kinase inhibitors do not cure advanced disease with the universal development of resistance which can have multiple causes. Thus, we need novel combinations and new resistance strategies. Further, these new therapies need novel testing strategies in early stage disease where they offer the possibility to improve 5-year survival rates.
As researchers in this field, we see great hope and potential. We know the groundbreaking research and innovative treatments being developed that tailor drugs to the genetic makeup of each patient. We believe the FDA selecting lung cancer for this patient-focused drug development is critical to pushing these treatments forward.
Too many of our patients have succumbed to this dreaded disease. The FDA's leadership and support for finding cures and treatments for lung cancer could make all the difference in longer survival and new hope for those who are faced with lung cancer.
Thank you,