Regulatory Focus™ > News Articles > FDA Considers Label Changes for Keytruda, Opdivo and Yervoy

FDA Considers Label Changes for Keytruda, Opdivo and Yervoy

Posted 12 July 2017 | By Zachary Brennan 

FDA Considers Label Changes for Keytruda, Opdivo and Yervoy

The US Food and Drug Administration (FDA) told Focus on Wednesday that the agency is considering labeling changes to include additional ocular inflammatory conditions for three immune checkpoint inhibitors.

Currently, the labels of Bristol-Myers Squibb’s Yervoy (ipilimumab), Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab) have uveitis listed as a potential immune-mediated adverse reaction (AR), and four of the five FDA-approved anti-PD1 therapies’ labels include uveitis.

The consideration for changing the labels of Yervoy, Opdivo and Keytruda comes as FDA says it has completed post-marketing reviews for sight-threatening complications such as retinal detachment and vision loss with the three treatments.

Tralisa Colby, an FDA public affairs specialist, explained to Focus: "Regulatory discussions are ongoing regarding PD-1 pathway blocking antibodies in attempts to improve the consistency and effectiveness of the information regarding immune-mediated ARs provided in the labels. Those labeling changes may include additional characterization of ocular inflammatory conditions; however, the current term, uveitis, should convey the severity and potential ocular complications to oncology physicians."

Ultimately, Colby said, the safety decision will be made in collaboration between FDA’s Office of Surveillance and Epidemiology and Office of New Drugs, with relevant discipline input across the agency as necessary.

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): January - March 2017

FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.