Pharma major Merck & Co. said the U.S. Food and Drug Administration (FDA) approved its cancer drug Keytruda (pembrolizumab) for intravenous injection as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
The approval is based on results from the Phase 3 KEYNOTE-177 trial, in which Keytruda significantly reduced the risk of disease progression or death by 40 percent compared with chemotherapy. It also more than doubled median progression-free survival (PFS) to 16.5 months, compared with 8.2 months with chemotherapy.
KEYNOTE-177 was a multi-center, randomized, open-label, active-controlled trial that enrolled 307 patients with previously untreated unresectable or metastatic MSI-H or dMMR colorectal cancer.
MSI-H and dMMR tumors contain abnormalities that affect the proper repair of DNA inside the cell. About 5 percent of patients with metastatic colorectal cancer have MSI-H or dMMR tumors.
Metastatic colorectal cancer is a serious and life-threatening disease with a poor prognosis. Available current therapy with chemotherapy combinations and other biologics are associated with substantial toxicity.
The approval was granted in less than one month following the submission of a new supplemental Biologics License Application (sBLA), which was reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program.
Until today, chemotherapy-containing regimens were the only FDA-approved first-line treatment options for patients with unresectable or metastatic MSI-H colorectal cancer. This approval helps address the unmet need to provide a new monotherapy treatment option for patients.
Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. It is a humanized monoclonal antibody that 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.
The FDA has previously approved Keytruda to treat at least seventeen types of cancer, including types of lung cancer, head and neck cancer, lymphatic cancer, urothelial cancer, colorectal cancer, gastric cancer, esophageal cancer, cervical Cancer, and renal cancer.
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