Moffitt Cancer Center Plays Pivotal Role in FDA Approval of New Anti-PD-1 Inhibitor Keytruda for Metastatic Melanoma

September 04, 2014

TAMPA, Fla. The U.S. Food and Drug Administration (FDA) announced the approval of a new cancer immunotherapy today to treat patients with metastatic melanoma, Keytruda (pembrolizumab) by Merck & Co.

The approval of Keytruda addresses an unmet medical need for patients with advanced melanoma whose cancer has progressed on prior therapies.

Jeffrey S. Weber, M.D., Ph.D., director of the Donald A. Adam Comprehensive Melanoma Research Center of Excellence at Moffitt Cancer Center, was one of the lead investigators of the PD-1 clinical trial which led to the drug receiving breakthrough status from the FDA.

“Pembrolizumab is the first PD-1 drug to be approved by the FDA, and it is a clearly effective drug that will prolong survival for many patients with metastatic melanoma.  This approval is a real advance, and a major milestone in the treatment of the disease,” Weber said.

The FDA approval of Keytruda will offer another treatment option to metastatic melanoma patients such as Carl Paulk, who enrolled in the clinical trial for this drug in 2012 after a different investigational therapy proved unsuccessful. “This drug has been great for me. My tumors have reduced and I have been able to continue work without side effects or energy loss,” Paulk said. 

FDA news release: 

About Moffitt Cancer Center
Located in Tampa, Moffitt is one of only 41 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s excellence in research, its contributions to clinical trials, prevention and cancer control. Moffitt is the No. 1 cancer hospital in the Southeast and has been listed in U.S. News & World Report as one of “Best Hospitals” for cancer since 1999. With more than 4,500 employees, Moffitt has an economic impact on Florida of nearly $1.6 billion. For more information, visit, and follow the Moffitt momentum on Facebook, Twitter and YouTube.