publication date: Jul. 13, 2018

Drugs & Targets FDA grants accelerated approval to Yervoy for MSI-H or dMMR metastatic colorectal cancer

FDA has granted accelerated approval to Yervoy (ipilimumab) for use in combination with Opdivo (nivolumab) for the treatment of patients 12 years of age and older with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

The agent is sponsored by Bristol-Myers Squibb Co. Inc.

This new use has also been added to the Opdivo (nivolumab) labeling. Nivolumab received accelerated approval for this indication as a single agent on July 31, 2017.

The approvals were based on data from Study CA209142 (CHECKMATE 142; NCT02060188), a multicenter, non-randomized, multiple parallel-cohort, open-label study that enrolled 82 patients with dMMR or MSI-H mCRC with disease progression during or following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. 

Assessment of dMMR or MSI-H tumor status was determined by local laboratories. All patients received ipilimumab 1 mg/kg by intravenous infusion and nivolumab 3 mg/kg IV every 3 weeks for 4 doses, followed by nivolumab 3 mg/kg IV as a single agent every 2 weeks, until unacceptable toxicity or radiographic progression. 

Among these 82 patients, the overall response rate as assessed by an independent radiographic review committee using RECIST 1.1 was 46% (95% CI: 35,58), with 3 complete … Continue reading FDA grants accelerated approval to Yervoy for MSI-H or dMMR metastatic colorectal cancer

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