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FDA Approves Nivolumab/Ipilimumab for MSI-H/dMMR Colorectal Cancer

Jason M. Broderick @jasoncology
Published: Wednesday, Jul 11, 2018

The FDA granted an accelerated approval to the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) following progression on a fluoropyrimidine, oxaliplatin, and irinotecan.

In August 2017, the FDA granted an accelerated approval to single-agent nivolumab for the treatment of adult and pediatric patients with MSI-H or dMMR mCRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

References

  1. Bristol-Myers Squibb’s Opdivo ® (nivolumab) + Low-Dose Yervoy ® (ipilimumab) is the First Immuno-Oncology Combination Approved for MSI-H/dMMR mCRC Patients Who Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin and Irinotecan. Published July 11, 2018. Access July 11, 2018. https://bit.ly/2uaofBD.
  2. Overman MJ, Lonardi S, Wong KYM, et al. Durable clinical benefit with nivolumab plus ipilimumab in DNA mismatch repair-deficient/microsatellite instability-high metastatic colorectal cancer. J Clin Oncol. 2018;36(8):773-779. doi: 10.1200/JCO.2017.76.9901.

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