SILVER SPRING, Md., Oct. 5 (UPI) -- The Food and Drug Administration approved a new drug for patients with advanced non-small cell lung cancer whose tumors have a specific genetic mutation.
The drug, Keytruda, was given breakthrough therapy designation and a sped-up approval because it was deemed to be a significant improvement over available treatments based on the results of clinical trials.
"Our growing understanding of underlying molecular pathways and how our immune system interacts with cancer is leading to important advances in medicine," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a press release. "Today's approval of Keytruda gives physicians the ability to target specific patients who may be most likely to benefit from this drug."
Keytruda blocks a cellular pathway found in the body's immune cells and some cancer cells, helping the immune system fight cancer cells. The drug specifically works in patients with a genetic mutation, which the FDA requires patients be tested for in order to be eligible for the treatment.
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The drug was tested with 550 advanced lung cancer patients, 61 of whom had the genetic mutation and already been treated with chemotherapy. In 41 percent of patients, tumors shrank after treatment with the drug, an effect that lasted between 2.1 and 9.1 months.
"The approval of this drug and a test to identify patients most likely to benefit has the potential to transform the way that lung cancer is treated," Dr. Edward Garon, a researcher at the University of California Los Angeles, told NBC News. "For people battling this deadly disease, this approach provides real hope of long-lasting responses while avoiding the toxicities of typical chemotherapy."
