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As sponsors of the research highlighted in your article about a breakthrough in cancer immunotherapy (front page, Dec. 10), we are reminded of the significant risks that cancer patients are willing to take with innovative treatments.
Unfortunately, major regulatory challenges remain regarding the approval and reimbursement of the novel, personalized immunotherapies pioneered by Dr. Carl June of the University of Pennsylvania.
Will the Food and Drug Administration be able to move beyond its expectation of randomized placebo-controlled trials when such practices are simply not feasible for many of the novel precision medicines in development?
Similarly, will payers recognize that while the upfront costs of such treatment may be steep, the overall effect on patients' well-being can save the health care system significant dollars?
At the Leukemia and Lymphoma Society, we are going beyond just financing the research that leads to these revolutionary treatments; we are pushing for the regulatory reform necessary for patients ultimately to have access to lifesaving treatments.
MARK VELLECA
Chief Policy and Advocacy Officer
Leukemia and Lymphoma Society
Washington, Dec. 11, 2012
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