Merck's Keytruda Granted Approval for Cervical Cancer Clinical Trial in China

By Baihuawen

On April 8, MSD’s pembrolizumab injection was approved in China for a clinical trial to treat cervical cancer. This indication had already been approved by the FDA in June 2018, making Keytruda the first PD-1 drug approved for the treatment of advanced cervical cancer.

Cervical cancer is one of the most common malignant tumors in gynecology and the second most prevalent cancer among women aged 15–44 years in China, surpassed only by breast cancer. The five-year survival rate for early-stage cervical cancer is relatively high; however, it declines sharply as the disease progresses. It is estimated that the five-year survival rates for patients with stage IA and IB cervical cancer are as high as 93% and 80%, respectively, whereas for those with stage IV disease, the survival rate drops to merely 15%–16%.

Keytruda achieved global sales of $11.084 billion in 2019. On April 9, the U.S. Food and Drug Administration (FDA) accepted Merck’s supplemental application for Keytruda in the treatment of patients with previously treated, unresectable or metastatic solid tumors characterized by high tumor mutational burden (TMB-H), granting it priority review status. The Prescription Drug User Fee Act (PDUFA) target date is June 18.