Immunotherapy Drugs Causing Vision Issues

The U.S. Food and Drug Administration (FDA) is investigating the potential for three immunotherapy drugs to cause retinal detachment and vision loss. The FDA will consider adding eye toxicities to the warning labels for pembrolizumab (Keytruda), nivolumab (Opdivo) and ipilimumab (Yervoy), which have shown promise in clinical trials involving malignant mesothelioma. All three have already been approved by the FDA for use with metastatic melanoma. Keytruda and Opdivo also have approval for head and neck cancers, colorectal cancers and certain non-small cell lung cancers. The FDA used its Adverse Event Reporting System (FAERS) to announce its concerns over the eye toxicities some patients experienced. The three drugs were listed in the category for “Potential Signal of a Serious Risk/New Safety Information.” The FDA notice said it would evaluate the need for regulatory action. Patients with Mesothelioma Benefit Although none of the drugs have been approved for use with mesothelioma, select patients have been using them in clinical trials or as part of a limited-use program, and some very successfully. Mesothelioma survivor Gene Hartline in Florida, for example, believes his health improved considerably after he started taking Opdivo. Walter Merth, a mesothelioma survivor from Pennsylvania, credits his dramatic turnaround to post-surgery therapy that includes Keytruda. Both told Asbestos.com the side effects they experienced were minimal. There are 10 ongoing mesothelioma cli...
Source: Asbestos and Mesothelioma News - Category: Environmental Health Authors: Source Type: news