Regulatory Affairs

Bristol-Myers Squibb’s Opdivo gets FDA nod for additional indication in colon cancer

PBR Staff Writer Published 02 August 2017

Bristol-Myers Squibb’s Opdivo (nivolumab) injection has secured approval from the US Food and Drug Administration to treat a subtype of metastatic colorectal cancer (mCRC).

Opdivo which has to be injected intravenously has been approved for treating mCRC patients whose disease is in the microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) form.

The approval is pertained to such adult and pediatric (12 years and older) patients in whom mCRC had progressed after treatment with fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy.

Bristol-Myers Squibb US commercial president Chris Boerner said: “As part of our commitment to address hard-to-treat cancers, with today’s approval, Opdivo provides a new treatment option for these patients who have historically faced a poor prognosis.

“This approval is one example of how our commitment to translational medicine and investigating predictive biomarkers may help us discover treatment approaches to address different patients’ unique needs.”

According to Bristol-Myers Squibb, the recommended dose of Opdivo is 240mg which is to be infused in the patient intravenously for 60 minutes once in every two weeks until disease progression or when the toxicity is found to be unacceptable.

The FDA approval was based on the results shown in CheckMate -142, a phase 2, multicenter, single-arm study in which Opdivo demonstrated an objective response rate of 28% among patients who were previously treated with fluoropyrimidine, oxaliplatin, and irinotecan.

Colon Cancer Alliance CEO Michael Sapienza said: “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.”


Image: A research campus operated by Bristol-Myers Squibb in Princeton, New Jersey. Photo: courtesy of Coolcaesar at English Wikipedia.