Bristol-Myers Squibb's Opdivo/Yervoy combo scores colorectal cancer OK; Former Akebia, Merrimack staffers found guilty
→ Bolstered by priority review and a breakthrough therapy designation, Bristol-Myers Squibb’s Opdivo/Yervoy has been approved for a subset of colorectal cancer patients who’ve run out of options. The FDA gave the green light — covering microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan combo — based on an ongoing Phase II trial. Eighty two out of 119 patients received treatment prior to the Checkmate-142 study; 46% in that sub-population, and 49% overall, responded to the I/O combo. Serious adverse reactions occurred in 47% of all patients — somewhat reflected in the list of safety warnings that come with the approval. The recommended dosing schedule involves an IV infusion every three weeks for four doses, followed by Opdivo maintenance therapy.
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