Posted from: Tuesday, August 07, 2018 - 01:19 PM - Present

Opdivo and Yervoy Approved to Treat Rare Colon Cancer

July 12, 2018 – The U.S. FDA has approved Opdivo® (nivolumab) and Yervoy® (ipilimumab), both manufactured by Bristol-Myers Squibb, to treat patients at least 12 years of age who have microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC). Eligible patients must have cancer that has progressed after treatment with fluoropyrimidine, oxaliplatin, and irinotecan.

MSI-H and dMMR metastatic colorectal cancer are both rare forms of colon cancer, affecting approximately 4% to 5% of patients diagnosed with mCRC. MSI-H and dMRR forms of mCRC can be difficult to treat. The approval of the Opdivo-Yervoy combination provides an additional option for patients who have not benefited from standard chemotherapy.

In an ongoing clinical trial, 46% of patients who had previously received fluoropyrimidine, oxaliplatin, and irinotecan responded to treatment with Opdivo and Yervoy. Of the patients who responded to treatment, 89% experienced a duration of response lasting six months or longer. Recommended dosing is 3mg/kg of Opdivo via intravenous (IV) infusion followed by 1mg/kg of Yervoy, also by IV infusion. The two drugs should be given on the same day, and administered once every three weeks for four doses. Opdivo should then be given as a maintenance therapy at a dosage of 240mg, delivered by IV infusion once every two weeks until disease progression or treatment intolerance. Yervoy carries a black box warning due to the risk of serious immune-mediated side effects.

Further study may be required for continued approval under the mCRC indication, as the current approval was granted through an accelerated pathway. The FDA has also approved Opdivo and Yervoy for use in combination to treat intermediate- or poor-risk advanced renal cell carcinoma, as well as unresectable or metastatic melanoma.

 

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Last Updated Saturday, August 18, 2018 - 08:14 PM.