FDA expands approval of Merck’s Keytruda to lung cancer

The FDA Friday gave an accelerated approval for Keytruda to treat advanced non-small cell lung cancer (NSCLC). Previously Keytruda was granted Breakthrough Therapy designation and Priority Review status for the new indication.

“We are pleased that today’s approval of Keytruda provides physicians and patients with a new anti-PD-1 immunotherapy option to help fight this deadly disease”, Andrea Ferris, president and chairman, LUNGevity Foundation, said in a statement.

Lung cancer is the leading cause of cancer death in the United States, with about 221,000 new cases and 158,000 deaths in 2015, according to the U.S. National Cancer Institute.

Earlier this year, the FDA approved the Bristol-Myers Squibb drug Opdivo (nivolumab) – which also targets the PD-1/PD-L1 pathway – to treat squamous non-small cell lung cancer.

Immunotherapies, also called immuno-oncology drugs, have brought the first significant advances in patient survival — though generally not cures — in many years for a few cancer types, particularly lung cancer and melanoma. By blocking the interaction, the drugs aim to enable the patient’s own immune system to attack the cancer.

A test will let doctors examine the tumors for PD-L1 levels before treatment.

Analysts estimate the class has multi-billion-dollar sales potential-fueled by hefty prices.

Merck said the price of Keytruda for health insurers and other payers is around $12,500 per month.

On Thursday, the FDA approved the use of a combination of Opdivo and an older Bristol immunotherapy, Yervoy, for the treatment of melanoma. In May, Leonard Saltz, an oncologist from Memorial Sloan Kettering Cancer Center called prices for new cancer drugs “unsustainable” in a speech at a meeting of cancer doctors. The results showed that treatment with Keytruda shrank tumors in 41% of patients with the effect lasting as long as 9.1 months.

“I think there’s going to be more and more interest on the part of oncologists in using PD-L1 expression in making decisions about how best to treat their lung-cancer patients”, Merck’s Dr. Perlmutter said.