FDA reviewing ocular toxicities for Opdivo, Yervoy and Keytruda

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...