Merck & Co., Inc. (NYSE: MRK), a leading US pharmaceutical company, has announced that its programmed death-1 (PD-1) inhibitor, Keytruda (pembrolizumab), has received expanded approval in China. The updated approval allows the drug’s package insert to be revised to include “pembrolizumab is suitable for the treatment of unresectable or metastatic melanoma,” broadening its use beyond the previous indication of “pembrolizumab is suitable for the treatment of unresectable or metastatic melanoma that has failed first-line therapy.”
Since its initial approval in China in 2018 for second-line advanced melanoma, Keytruda has now become the first and only PD-1 inhibitor approved for first-line melanoma treatment in the country. The drug has accumulated a dozen indications in China, spanning a range of cancers including melanoma, non-small cell lung cancer, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, colorectal cancer, hepatocellular carcinoma, triple negative breast cancer, MSI-H/dMMR solid tumor, gastric cancer, bile duct cancer, and others. – Flcube.com
