Bringing New Therapies to Market
Today’s post was written by Bert E. Thomas IV, PhD, MBA, CEO of the Sarcoma Foundation of America.
Over the past few weeks we’ve seen the Food and Drug Administration (FDA) make decisions regarding some investigational therapies for sarcoma. In that time, one investigational new drug received priority review status, which cuts the drug review period from 10 months to six months. Another was given fast track designation. This designation is also intended to expedited the review process for “serious conditions with unmet medical need.” Certainly sarcoma falls into that category.
The Sarcoma Foundation of America (SFA) has long been a champion for these types of expedited review programs. The SFA has supported legislation, including language in the 2012 Food and Drug Administration Safety and Innovations Act (FDASIA) that directed the FDA to improve access to the accelerated approval pathway. The SFA has also encouraged the FDA to use their flexibility in the drug review process, with the idea that these programs would encourage pharmaceutical companies to move forward on drug development for diseases like sarcoma. It is important to note that it is no one’s intention to trade off safety and efficacy for speed in review and approval. All involved agree that it is still vital that the therapies that reach patients are properly reviewed and approved based on scientific merit.
The SFA is excited to see that drug companies are, in fact, utilizing these mechanisms to help speed the delivery of new therapies to sarcoma patients. We are hopeful that this signals a new era in sarcoma drug development and these are merely the first in a long line of treatments that may improve the lives of the patients who are in desperate need of new options.
No doubt there is much still left to be done. However, we are in a moment in time where there is a renewed feeling of optimism. And we will let the optimism continue to spur us on in our efforts to find the cure in our time.