The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
Keytruda is sponsored by Merck.
This recommendation is based on results from the pivotal phase III KEYNOTE-177 trial, in which Keytruda, as a monotherapy, demonstrated a significant improvement in progression-free survival compared to chemotherapy (investigator’s choice: mFOLFOX6 with or without bevacizumab or cetuximab; or FOLFIRI with or without bevacizumab or cetuximab), a current standard of care.
Data from KEYNOTE-177 were presented at the virtual scientific program of the 2020 American Society of Clinical Oncology Annual Meeting and were published in The New England Journal of Medicine. The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the first quarter of 2021.Servier and Celsius Therapeutics collaborate on colorectal cancer research
Servier and Celsius Therapeutics have formed a strategic collaboration focused on the identification and validation of novel colorectal cancer drug targets.
“Through this collaboration, we will leverage Celsius’ single-cell genomics platform, machine learning capabilities, and target validation expertise to refine our understanding of the different subtypes of CRC and discover new drug targets with the goal of developing novel precision therapies for specific patient subsets,” Hugues Dolgos, global head of oncology research and development at Servier, said in a statement. “Servier will discover and develop candidate drugs leveraging our end-to-end small molecule and large molecule capabilities.”
Under the terms of collaboration, Celsius will analyze hundreds of samples from defined CRC patient populations using its proprietary single-cell genomics platform and will work to identify and validate new drug targets during the three-year research period. Servier will receive an exclusive option to research, develop, and commercialize products directed to up to three of the targets.
Celsius would receive an upfront payment and research funding, and would be eligible to receive over $700 million in potential discovery, development, and commercialization milestone payments, along with tiered royalties.
A modest proposal from a former FDA commissioner: Add antidepressants to the nation’s water supply
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