FDA OKs Keytruda for certain advanced non-small cell lung cancer cases

SILVER SPRING, Md. — The Food and Drug Administration recently granted Merck’s Kaytruda (pembrolizumab) injection accelerated approval for use among patients with metastatic non-small cell lung cancer and who have tumors expressing the protein PD-L1. So far in 2015, there have bee 221,200 new cases of lung cancer and 158,040 deaths from the illness, according to the National Cancer Institute.

“Our growing understanding of underlying molecular pathways and how our immune system interacts with cancer is leading to important advances in medicine,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval of Keytruda gives physicians the ability to target specific patients who may be most likely to benefit from this drug.”

Keytruda, which was granted accelerated approval for use with advanced melanoma patients after being treated with ipilimumab last September, targets PD-L1 and blocks it in the hope of bolstering the immune system’s ability to fight cancer cells.

“Today’s approval of KEYTRUDA is the result of our deep commitment to bring the benefits of immunotherapy to cancer patients,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “Together with scientists and physicians around the world, we endeavor to improve the lives of patients suffering from these grievous illnesses.”