BMS Receive the CHMP’s Positive Opinion Recommending Approval of Opdivo (nivolumab) + Yervoy (ipilimumab) for dMMR or MSI-H mCRC After Prior Chemotherapy

May 24, 2021 Auto Bot approval, BMS, CHMP, FDA, ipilimumab, Nivolumab, Opdivo, Positive Opinion, regulatory, Yervoy 0

Shots:

  • The opinion is based on P-II CheckMate -142 study assessing Opdivo + Yervoy in patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer whose disease had progressed during or after prior treatment with CT
  • If approved, Opdivo in combination with Yervoy will be the first dual immunotherapy approved in the EU in gastrointestinal cancer
  • The combination regimen receives the US FDA’s approval in Jul’2018 for adults and pediatric patients aged ≥12yrs. with MSI-H or dMMR mCRC that has progressed following treatment with CT. The dual regimen receives PMDA approval in Sept’2020 for MSI-H unresectable, advanced or recurrent colorectal cancer progressing after CT

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