Merck Announces Approval of KEYTRUDA® in Combination with Padcev®
Tuesday, April 04, 2023
Merck announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumour response rate and durability of response. This is the first time an anti-PD-1 therapy approved in combination with anantibody-drug conjugate in the U.S. in these patients.
This approval is a major milestone in the treatment of patients with locally advanced or metastatic urothelial carcinoma since it is the first approved combination of an immunotherapy and an antibody-drug conjugate for these patients. This expands the use of KEYTRUDA-based regimens to more patients with advanced urothelial carcinoma and demonstrates the value of collaboration in creating new combination approaches for patients in need of more options.
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumour cells. KEYTRUDA is a humanised monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes affecting both tumour cells and healthy cells.
