MRF Meets with FDA on State of Melanoma Drug Development

The Melanoma Research Foundation (MRF) met on November 15, 2010 with high-level officials at the Food and Drug Administration (FDA), including Dr. Richard Pazdur, the Director of the Office of Oncology Drug Products.  

The Melanoma Research Foundation (MRF) met on November 15, 2010 with high-level officials at the Food and Drug Administration (FDA), including Dr. Richard Pazdur, the Director of the Office of Oncology Drug Products.  

The purpose of the meeting was to exchange ideas and insights into the state of melanoma drug development.  The MRF team included leading clinical researchers who are involved with the MRF Scientific Advisory Committee (SAC) and the new MRF Breakthrough Consortium.  This team, led by the SAC’s co-chair, Dr. Lynn Schuchter, the Consortium’s Chief Medical Officer, Dr. Alison Martin, and Randy Lomax, chair of the MRF Board of Directors, presented information on several key areas relevant to the development of future treatments, including: staging, presented by Dr. Jeff Gershenwald of MD Anderson; targeted therapies, presented by Dr. Keith Flaherty of Massachusetts General Hospital; and, immunotherapy, presented by Dr. Steve Hodi of the Dana Farber Cancer Institute.  

Dr. Pazdur included senior staff from key areas of FDA, which resulted in a beneficial discussion of critical issues that are increasingly important to melanoma.  For example, what can be done to accelerate studies and approval of combination therapies, an approach that most researchers are convinced is the most promising?  How can we encourage timely development of diagnostic kits that will provide information about whether or not a patient has a particular mutation targeted by a specific drug?  When does it make sense to use “progression free survival” as a goal for drug approval rather than relying on the gold standard of “overall survival”?

This meeting highlights the complexity of the drug development and approval process.  Clearly much work remains to be done and additional collaboration and sharing of ideas are essential.  However, the discussion demonstrates both progress that has been made, and areas that hold the most hope and promise for people with melanoma.