On September 14, MSD announced its PD-1 inhibitorPembrolizumab(Product name: Keytruda) has been approved by China NMPA,First-line treatment for unresectable or metastatic melanoma. This approval updates the product's instruction manual, changing the melanoma indication from "Pembrolizumab is applicable for the treatment of unresectable or metastatic melanoma that has failed first-line therapy."Changed to"Pembrolizumab is applicable for the treatment of unresectable or metastatic melanoma.」。
Screenshot source:NMPA Official Website
So far, pembrolizumab has been approved in China for more than ten indications, covering 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 tumors, gastric cancer, cholangiocarcinoma, and other types of cancers.Malignant melanoma arises from the malignant proliferation of melanocytes. In China, the age-standardized incidence rate of malignant melanoma is approximately 0.37 per 100,000, classifying it as a rare malignant tumor. In 2022, there were about 0.88 thousand new cases of cutaneous melanoma in China, with approximately 0.54 thousand deaths."Malignant melanoma is one of the more difficult cancers to treat effectively. In China, most cases of malignant melanoma are diagnosed at an advanced stage. With the approval of several PD-1 inhibitors in China in 2018, immunotherapy has become one of the recommended second-line or higher salvage treatments for advanced malignant melanoma in China."Professor Guo Jun from Peking University Cancer Hospital"We are very pleased to see that pembrolizumab will potentially offer a new option and hope for more patients with advanced melanoma."
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