The Food and Drug Administration (FDA) is evaluating certain adverse event reports with the cancer drug Opdivo regarding retinal detachment and severe vision loss through its drug safety evaluations program. The biologic was also linked to tumor lysis syndrome, or TLS, a group of metabolic abnormalities that can occur as a treatment of cancer.
The side effects were identified during a review of adverse event reports made to the FDA for New Drug Applications (NDAs) and Biologics License Applications (BLAs). Evaluations are done to determine if there are any new serious adverse events not previously identified during product development, known side effects reported in unusual number, or potential new safety concerns now that the products are being used in the general population.
Beginning no later than 18 months after approval, scientists from the Office of Surveillance and Epidemiology and Office of New Drugs in the Center for Drug Evaluation and Research (CDER) jointly review the relevant data, summarize the findings and, when necessary, develop a plan to further investigate potential new safety issues.
Opdivo was approved December 2014 for the treatment of metastatic melanoma, non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, recurrent or metastatic squamous cell carcinoma of the head and neck, and locally advanced or metastatic urothellal carcinoma. The injection contains the active ingredient nivolumab.
The FDA said it will continue to evaluate the reports of adverse events regarding retinal detachment, severe vision loss and tumor lysis syndrome in patients treated with Opdivo to determine whether regulatory action is required.
Any adverse events related to use of Opdivo should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm
Source: FDA Postmarket Drug and Biologic Safety Evaluations