Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA (pembrolizumab) monotherapy, the company’s anti-PD-1 (programmed death receptor-1) therapy, at a dose of 2 mg/kg every three weeks, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy.
Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
Under FDA’s accelerated approval regulations, this indication for KEYTRUDA is approved based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
KEYTRUDA is the first and only anti-PD-1 therapy approved for both squamous and non-squamous metastatic NSCLC.
In addition to approving KEYTRUDA for NSCLC, FDA approved the first companion diagnostic that will enable physicians to determine the level of PD-L1 expression in a patient’s tumor.
In KEYNOTE-001, the clinical study supporting the FDA Breakthrough Designation for KEYTRUDA and this approval, KEYTRUDA demonstrated an overall response rate of 41 percent (n=25/61) in patients with a PD-L1 expression tumor proportion score (TPS) of 50 percent or more; all responses were partial responses (95% CI, 29, 54). Eighty-four percent (n=21/25) of those who responded had ongoing responses, including 11 patients with ongoing responses of six months or longer.
Immune-mediated adverse reactions occurred with KEYTRUDA including pneumonitis, colitis, hepatitis, hypophysitis, hyperthyroidism, hypothyroidism, type 1 diabetes mellitus, and nephritis. Based on the severity of the adverse reaction, KEYTRUDA (pembrolizumab) should be withheld or discontinued and corticosteroids administered.
Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Female patients of reproductive potential should be advised of the potential hazard to a fetus. For more information regarding immune-mediated adverse reactions and use in pregnancy, see “Selected Important Safety Information” below.
“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.”
KEYTRUDA is an immunotherapy that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby helping the immune system do what it is meant to do: help detect and fight cancer cells. KEYTRUDA can also cause the immune system to attack normal organs and tissues.
“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,” said Andrea Ferris, president and chairman, LUNGevity Foundation. “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 is the first and only anti-PD-1 therapy approved for both squamous and non-squamous metastatic NSCLC. In addition to approving KEYTRUDA for NSCLC, FDA approved the first companion diagnostic that will enable physicians to determine the level of PD-L1 expression in a patient’s tumor.
Published 06 October 2015