Country: UNITED STATES | Region: NORTH AMERICA | Type: Drug Approval | Keywords: #fda #merck #msd #oncologycenterofexcellence #projectorbis #realtimeoncologyreview #rtor
- The U.S. Food and Drug Administration (FDA) has approved Merck’s Keytruda (pembrolizumab) 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
- Approval from the FDA is based on results from the Phase 3 KEYNOTE-177 trial in which Keytruda not only significantly reduced the risk of disease progression or death by 40% but also more than doubled median progression-free survival (PFS) compared with the current standard of care, chemotherapy
- The approval was reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program and Project Orbis, a collaborative initiative through the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among the U.S., Canada, Australia, Switzerland, and Singapore
THE DETAILS
WASHINGTON, D.C., The United States – The U.S. Food and Drug Administration (FDA) has approved Merck’s Keytruda (pembrolizumab) 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.
Approval from the FDA is based on results from the Phase 3 KEYNOTE-177 trial in which Keytruda not only significantly reduced the risk of disease progression or death by 40% but also more than doubled median progression-free survival (PFS) compared with the current standard of care, chemotherapy.
Dr. Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck, said, “Today’s approval has the potential to change the treatment paradigm for the first-line treatment of patients with MSI-H colorectal cancer, based on important findings from KEYNOTE-177 that showed Keytruda monotherapy demonstrated superior progression-free survival compared to standard of care chemotherapy.
“Our commitment to pursuing biomarker research continues to help us bring new treatments to patients, particularly for those who have few available options.”
The approval comes less than a 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.
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