ARTICLE | Clinical News

FDA reviewing ocular toxicities for Opdivo, Yervoy and Keytruda

September 1, 2017 3:11 PM UTC

In June, an alert from the FDA Adverse Event Reporting System (FAERS) noted that the agency is evaluating potential regulatory action for Opdivo nivolumab (BMS-936558, MDX-1106, ONO-4538), Yervoy ipilimumab (BMS-734016) and Keytruda pembrolizumab (MK-3475), citing safety concerns of "ocular toxicities including vision loss and retinal detachment."

Opdivo is approved to treat renal cell carcinoma (RCC), advanced microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC), melanoma, non-small cell lung cancer (NSCLC), classical Hodgkin's lymphoma, squamous cell carcinoma of the head and neck (SCCHN) and urothelial carcinoma, with accelerated approval in some settings...