US-based Merck Sharp & Dohme’s (MSD, NYSE: MRK) programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab) has obtained its 10th indication approval from China’s National Medical Products Administration (NMPA). The drug can now be used to treat early high-risk triple negative breast cancer (TNBC) with tumors expressing PD-L1 (CPS ≥ 20) in combination with a neoadjuvant therapy and as a monotherapy in adjuvant therapy for patients with this indication.
TNBC Treatment Landscape
At present, treatment options for early-stage TNBC are limited, with 30% to 40% of patients experiencing recurrence and metastasis after standard treatment due to a lack of effective targets. This approval of Keytruda marks a significant advancement in addressing this unmet need.
Keytruda’s Regulatory Milestones in China
First approved in China in July 2018, Keytruda has since received multiple indications for treating various cancers, including melanoma, non-small cell lung cancer, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, colorectal cancer, gastric cancer, and hepatocellular carcinoma. The latest approval for TNBC further expands the drug’s therapeutic applications in China.-Fineline Info & Tech
