Opdivo + Yervoy receives Positive CHMP Opinion for colorectal cancer

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy. 

The opinion was based on data from the phase II CheckMate -142 trial. The European Commission, which is authorized to approve medicines for the European Union, will now review the CHMP recommendation.

Opdivo and Yervoy are sponsored by Bristol Myers Squibb.

YOU MAY BE INTERESTED IN

New Medicaid work requirements included in President Donald Trump’s “One Big Beautiful Bill Act” could result in as many as 1.6 million missed screenings for breast, colon, and lung cancers within the first two years, researchers at the University of Chicago reported in a paper published in JAMA Oncology earlier this month.

By law, the Food and Drug Administration is required to determine whether a drug, device, biologic, or medical device is “safe and effective.” But the FDA determination does not control whether the Centers for Medicare & Medicaid Services will pay for it.  To satisfy CMS, medical products and services must be “reasonable and necessary,” meaning...

As a radiation oncologist, I am struck by how often the decisive variable in lung cancer is not the sophistication of our therapy, but the timing of our encounter with the disease.  The American Cancer Society projects 618,120 cancer deaths in the United States in 2025, with lung cancer remaining as the single largest contributor,...

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login