FDA To Increase Collaboration On Lung Cancer Treatments Using Master Protocol

The Food and Drug Administration (FDA) stated in a post on the FDAVoice that it hopes to continue collaborating with drug researchers on lung cancer treatments and to develop a master protocol for testing drugs. The federal agency said that the recent approval of Zykadia was an important step in non-small cell lung cancer (NSCLC) treatment.

Richard Pazdur, M.D., and Gideon Blumenthal, M.D., co-wrote the article saying that, while there have been successes, more progress in treatment development is needed as there are too many cancer mutations with no or few treatments available.   

FDA Actions

The FDA approved Zykadia (certinib) in May of 2014. It is one of four therapies approved for NSCLC since 2011. The agency says that the approval represents its new, forward-thinking approach and its critical role in bringing industry, health professionals, and other groups together. The FDA credits the careful review process with analyzing the data efficiently and quickly. Additionally, the FDA’s

breakthrough drug designation streamlined the development process by focusing everyone’s efforts. In summary, the FDA believes that the components of the development process worked well within the agency, saying, “It took less than four years — versus the roughly ten years it used to take — from the initial study of a drug to FDA approval.”

Collaboration

The FDA hopes to extend and increase collaboration with drug companies, universities, CROs, health professionals, experts, and consumer groups. One area of interest is data mining, as recent applications have included high quality datasets, which the FDA found helpful. Recent advances in the molecular and genetic profiles of lung cancer have enabled investigators to analyze the varying cancers by subtype. Identifying subtypes and driver oncogenes have helped develop targeted therapies, so the agency would like to make more progress in this area during collaborative processes.

Master Protocol

Another way in which the agency hopes to collaborate is in the development of a master protocol. With this overarching plan, researchers can run one clinical trial to test multiple drugs. They can also test biomarkers in a single, ongoing trial. The FDA says that this approach is based on individual patient profiles, so researchers have more discretion in assigning patients. The customized trial design will improve efficiency in trials and provide effective treatments for patients with little or no hope for treatment.