The approval follows the FDA’s Oncologic Drugs Advisory Committee voting 5-3 in favor of maintaining the approval despite a confirmatory trial that found Keytruda did not meet the end points of overall survival and progression-free survival.
The combination bamlanivimab and etesevimab can resume use and distribution to treat mild-to-moderate COVID-19 but only in states where variants resistant to the therapy are low.
ICER’s policy recommendations suggest payers establish step therapy with less expensive systemic agents to allow patients and clinicians to choose from multiple options.
The monoclonal antibody had been given an emergency use authorization to treat COVID-19, but the recent spike in cases is driving a shortage in supply.