Merck & Co., Inc. has announced that the U.S. Food and Drug Administration (FDA) has designated its drug, Keytruda (pembrolizumab), as breakthrough therapy for the treatment of patients with epidermal growth factor receptor (EGFR)-negative and anaplastic lymphoma kinase (ALK)-negative non-small cell lung cancer (NSCLC) who have progressed during or after platinum-based chemotherapy.
The breakthrough therapy designation by the FDA is due to findings from the ongoing phase 1b KEYNOTE-001 trial, which were presented last month at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain. Breakthrough therapy designation is used by the FDA to accelerate the development and evaluation of an investigational drug that is intended to treat a serious or life-threatening illness.
Keytruda, a human programmed death receptor-1 (PD-1) blocking antibody, was initially approved by the FDA earlier this year for the treatment of patients with unresectable or metastatic melanoma whose disease progressed following ipilimumab and possibly, a BRAF inhibitor. Keytruda is recommended at a dose of 2 mg/kg administered intravenously every 3 weeks. Keytruda is currently being studied as monotherapy and in combination for the treatment of numerous types of cancers.
Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) mutation-negative, and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative non-small cell lung cancer (NSCLC) whose disease has progressed on or following platinum-based chemotherapy.
This is the second Breakthrough Therapy Designation granted for Keytruda.