Federal officials approved a new drug Friday for last-ditch treatment of the deadliest cancer of all — advanced lung cancer.
The drug, called Keytruda, uses the body’s immune system to fight tumors. It’s already been approved for melanoma and the new approval speeds the way for insurers to pay for it for lung cancer patients.
The Food and Drug Administration approval links the drug to a test. The test tells doctors if patients have the genetic mutation that the drug targets.
“Our growing understanding of underlying molecular pathways and how our immune system interacts with cancer is leading to important advances in medicine,” said FDA’s Dr. Richard Pazdur. “Today’s approval of Keytruda gives physicians the ability to target specific patients who may be most likely to benefit from this drug.”
"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."
Keytruda, also called pembrolizumab, is tailored to fight tumors that a faulty function in a pathway known as PD-1/PD-L1.
“By blocking this pathway, Keytruda may help the body’s immune system fight the cancer cells,” the FDA said.
A similar drug called Opdivo, or nivolumab, was approved earlier this year. They’re both monoclonal antibodies – lab-engineered immune system proteins that help the body attack and kill tumors. Both are expected to cost about $12,500 a month each.
"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," said Dr. Edward Garon, who led studies of the drug at the University of California Los Angeles.
“For people battling this deadly disease, this approach provides real hope of long-lasting responses while avoiding the toxicities of typical chemotherapy."
About a quarter of the lung cancer patients in Garon’s trial had tumors with faulty PD-1 function. The drug shrank the tumors in 41 percent of these patients, with the effects lasting for as long as nine months.
That’s a big effect in patients whose tumors have come back after rounds of chemotherapy. The side-effects were not as serious as with most chemotherapy and included fatigue, shortness of breath and loss of appetite.
The FDA speeded the drug’s approval. It’s still not clear whether it helps patients live any longer, however.
Lung cancer is the No. 1 cancer killer, with 221,200 new cases and 158,000 deaths expected this year in the U.S., according to the National Cancer Institute.
Earlier this week the FDA approved a combination of Opdivo and another immune-targeting cancer drug called Yervoy to treat melanoma – a duo that could cost $250,000 a year.