RIYADH — MSD (Merck Sharp & Dohme) – a global healthcare leader, revealed recently that the US 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.
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. However, immune-mediated adverse reactions occurred with Keytruda including pneumonitis, colitis, hepatitis, hypophysitis, hyperthyroidism, hypothyroidism, type 1 diabetes mellitus, and nephritis. The most common adverse reactions (reported in at least 20% of study patients) were fatigue (44%), cough (29%), decreased appetite (25%), and dyspnea (23%).
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.
The “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.”
“This important news means that we now have a new immunotherapy option to help patients with squamous and non-squamous metastatic non-small cell lung cancer with disease progression on or after platinum-containing chemotherapy and whose tumors express PD-L1,” said Dr. Naiyer Rizvi, director of thoracic oncology and director of immunotherapeutics, New York Presbyterian Hospital, Columbia University Medical Center, and a principal investigator for the Keytruda lung cancer clinical program.
