Merck announced that the U.S. Food and Drug Administration (FDA) has
granted Breakthrough Therapy Designation to KEYTRUDA®
(pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of
patients with microsatellite instability high (MSI-H) metastatic
colorectal cancer. This is the third Breakthrough Therapy Designation
granted for KEYTRUDA.
The FDA’s Breakthrough Therapy Designation is intended to expedite the
development and review of a candidate that is planned for use, alone or
in combination, to treat a serious or life-threatening disease or
condition when preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over existing therapies on one or
more clinically significant endpoints. KEYTRUDA was previously granted
breakthrough status for advanced melanoma and advanced non-small cell
lung cancer (NSCLC).
The Breakthrough Therapy Designation in advanced colorectal cancer is
based on data from a Phase 2 study evaluating the activity of KEYTRUDA
in cancers with microsatellite instability, a well-established feature
seen in cells with certain types of DNA repair defects. Findings from
the study, led by researchers from Johns Hopkins Kimmel Cancer Center,
were presented at the 2015 American Society of Clinical Oncology
(ASCO) annual meeting and were published simultaneously in the New
England Journal of Medicine.
KEYTRUDA is a humanized monoclonal antibody that works by increasing the
ability of the body’s immune system to help detect and fight tumor
cells. KEYTRUDA blocks the interaction between PD-1 and its ligands,
PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both
tumor cells and healthy cells.
