Bristol-Meyers Squibb's Opdivo (nivolumab) has just been approved by the FDA
for patients with a microsatellite instability-high tumors (also known as MSI-H) or mismatched repair deficiency (dMMR). The approval was specifically for patients whose cancer has progressed following Fluoropyrimidine, Oxaliplatin, and Irinotecan.
Opdivo joins Merck's Keytruda (pembrolizumab)
as the second immunotherapy drug to be approved within four months. Here's what you need to know.
What is Immunotherapy?
Immunotherapy refers to a number of different strategies where the goal is to harness a person’s own immune system to fight cancer. The most widely used approach in cancer involves drugs called immune checkpoint inhibitors
. These enhance the body’s immune response by blocking signals which otherwise suppress immune activity, such as PD-1 or CTLA-4 – as a result, these are frequently described as working by ‘releasing the brakes’ on the immune system.
“As the third most common type of cancer in the United States, our view is that colorectal cancer – particularly for those with dMMR or MSI-H metastatic disease – has been in need of new research and treatments. The approval of Opdivo
for appropriate patients with this disease gives the community more hope,” said Michael Sapienza, CEO of the Colon Cancer Alliance.
How Does Opdivo Work?
Opdivo works by blocking a signal in your body called PD-1 (or PD-L1). It is given through intravenous infusion over one hour in intervals of two weeks.
In the CheckMate -142 Trial, 28% responded to Opdivo who had received prior treatments with a fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy, with almost 2% showing a complete response and 30% showing a partial response.
What if I Am Not MSI-H or dMMR?
All patients should be sure their tumor has MSI and MMR testing (or equivalent) performed, which now should be standard of care for most patients according to NCCN guidelines. Even if you've been tested before, it may be worth talking to your doctor again. Cancer cells are constantly mutating, which means that you could become MSI-H in the future.
While there are not currently any immunotherapy drugs approved for the 97% of patients who are not MSI-H, all is not lost. There are scores of drug combinations and new immunologic targets are being investigated, with a few of these achieving preliminary successes.
The best way to find these treatments is through our new Clinical Trials Finder
, which can match you with trials based on your location, stage, tumor type, and more!
Don’t forget, the Colon Cancer Alliance serves as a source of information about colon health. If you have additional questions about colon cancer screening or are in need of support, please contact our free Helpline at (877) 422-2030. We’re here to help.