Merck Wins Approval for Keytruda in a few With Lung Cancer

In 2014, the FDA approved Keytruda to treat patients with advanced melanoma following treatment with Yervoy (ipilimumab), another type of immunotherapy.


The FDA Friday gave an accelerated approval for Keytruda to treat advanced non-small cell lung cancer (NSCLC). Merck estimates roughly 25% of all non-small-cell lung-cancer patients have PD-L1 levels that would make them eligible for Keytruda treatment, Roger Perlmutter, Merck’s research chief, said in an interview Friday. “It is an exciting time as more treatment options are becoming available that help to combat cancer by harnessing the power of the body’s own immune system”.

Keytruda and another similar treatment from Bristol-Myers Squibb Co called Opdivo are antibodies created to block the interaction between PD-L1 and another protein, PD-1, whose natural function is to put checks on the immune system. Previously Keytruda was granted Breakthrough Therapy designation and Priority Review status for the new indication.

Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute. The researchers found that tumors shrank in 41 percent of patients treated with Keytruda and the effect lasted between 2.1 and 9.1 months.

The safety of Keytruda was studied in 550 patients with advanced NSCLC. The FDA also approved a companion diagnostic developed by Dako North America test for PD-L1, to screen for patients who should receive Merck’s Keytruda.

T cells from attacking cancer.

Established in 1984, the Society for Immunotherapy of Cancer (SITC) is a non-profit organization of medical professionals dedicated to improving cancer patient outcomes by advancing the development, science and application of cancer immunotherapy and tumor immunology.


The accelerated approval is for use in patients with advanced non-small cell lung cancer (NSCLC) across all histologies whose disease has progressed on or after platinum-containing chemotherapy, as well as a targeted agent in epidermal growth factor receptor- or anaplastic lymphoma kinase-positive patients. The most common side effects included fatigue, loss of appetite, dyspnea, and cough. Approximately a quarter of screened patients in the trial had PD-L1 expression in at least half of their tumor cells. The drug also has the potential to cause severe immune system-related side effects involving the lungs, colon, hormone-producing glands, nervous system, as well as rash and blood vessel inflammation, the FDA said.

FDA expands approval of Merck's Keytruda to lung cancer