Merck gets FDA nod for new indication of Keytruda
Merck has received the Food and Drug Administration’s nod for a new indication for its drug Keytruda. It now is approved to treat patients with locally advanced or metastatic esophageal or gastroesophageal junction carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy.
“Because esophageal cancer generally has poor survival rates, new first-line therapies are urgently needed for these patients,” said Peter Enzinger, director of the Center for Esophageal and Gastric Cancer, Dana-Farber/Brigham and Women’s Cancer Center. “Today’s approval of this indication for Keytruda introduces a new option, which has shown a superior survival benefit compared to FU and cisplatin alone, for newly diagnosed patients with locally advanced or metastatic esophageal or GEJ carcinoma that is not amenable to surgical resection or definitive chemoradiation, regardless of PD-L1 expression status and tumor histology.”
“There have been few advances in improving survival outcomes in the first-line treatment setting for esophageal cancer over the last three decades,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We are committed to putting patients first and continuing our research to help advance new approaches to potentially extend the lives of people with cancer. We thank all of the patients, their caregivers and healthcare professionals who participated in the study.”
Keytruda indications include certain types of melanoma; Non-Small Cell Lung Cancer; head and neck squamous cell cancer; classical Hodgkin Lymphoma; Primary Mediastinal Large B-cell lymphoma; urothelial carcinoma; microsatellite instability-high or mismatch repair deficient colorectal cancer; gastric cancer; cervical cancer; hepatocellular carcinoma; Merkel cell carcinoma; renal cell carcinoma; tumor mutational burden-high; cutaneous squamous cell carcinoma; and triple-negative breast cancer.