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San Antonio’s START gains more recognition in global cancer fight
September 5, 2014

Dr. Amita Patnaik, associate director of clinical research for START, was the principal investigator for the MK-3475 drug trial in San Antonio. Photo by Erik Reyna.

By W. Scott Bailey, San Antonio Business Journal

The U.S. Food and Drug Administration has approved a new treatment option for patients with advanced melanoma. The clearance of MK-3475, or pembrolizumab, further underscores the impact San Antonio-based START is having on cancer research.

The approved drug, a Merck compound, was initially tested at START, which is located in the South Texas Medical Center and operates one of the world's largest Phase I clinical trial programs for new anti-cancer agents.

Dr. Amita Patnaik, associate director of clinical research for START, was the principal investigator for the MK-3475 trial in San Antonio. She says the drug will have a "transformative" affect on cancer care.

"A breakthrough of this proportion happens rarely and will give both oncologists and patients a significant, new treatment option and will likely become the standard of care for patients with late-stage melanoma," Patnaik says.

Roughly 75 percent of skin cancer deaths are attributed to advanced melanoma.

Merck officials say MK-3475 is the first anti-PD-1 (programmed death receptor-1) therapy approved in the U.S. and has received the FDA's Breakthrough Therapy designation for advanced melanoma. The designation was granted based on the significance of early study findings and unmet medical need.

Merck plans to market pembrolizumab under the brand name Keytruda.

"This FDA approval is also important news for San Antonio," Patnaik explains. "In the world of cancer research, San Antonio is ground zero, and what many may not realize is that a large proportion of FDA-approved anticancer agents were first used in patients here."

START also has operations in Madrid and Shanghai.

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