SHANGHAI, China, Feb. 4, 2024 - Merck Sharp & Dohme announced that its PD-1 inhibitor pembrolizumab (trade name: KEYTRUDA®) has been approved by the China National Drug Administration (NMPA) in combination with gemcitabine and cisplatin for the first-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC).

This new indication approval is based on data from the global Phase III clinical trial KEYNOTE-966.

Anna Van Acker, Global Senior Vice President and President of Merck Sharp & Dohme China, said, "We are pleased to see that the innovative drug review and approval process continues to accelerate, driven by the full implementation of the Healthy China 2030 strategy, and that accessibility has increased dramatically, especially in terms of clinically-needed new medicines. In recent years, the incidence of biliary tract malignancies has been on the rise, and there are limited treatment options for patients with advanced stages. As a leader in the field of oncology treatment, we are committed to covering more malignant tumors with high morbidity and mortality rates, low overall survival rates, and high treatment difficulty, and to bringing more innovative treatment options to cancer patients at a faster pace."

Biliary tract malignancies are malignant tumors originating from the epithelial cells of the bile ducts, which are characterized by difficulties in early diagnosis, low rates of radical resection, and high rates of recurrence. Biliary tract cancers mainly include gallbladder cancer and intra- and extrahepatic bile duct cancer. Among them, intra- and extrahepatic cholangiocarcinoma is the second largest primary liver cancer after hepatocellular carcinoma, accounting for about 10%~15% of primary liver cancers.

https://mp.weixin.qq.com/s/FJ4prENGNtAl-LmO9s70dw

责编: editor