The role of FDA’s Center for Drug Evaluation and Research (CDER ) is to provide study design elements and relevant data for effective drug application. The list includes new molecular entities (NMEs), therapeutic biologic products, and previously approved other drugs. Among many others, the combination of nivolumab – a programmed death receptor-1 (PD-1) blocking antibody , and relatlimab – a lymphocyte activation gene-3 (LAG-3) blocking antibody has received its initial FDA approval to treat unresectable or metastatic melanoma in adults or children aged above 12 years via injectable administration. The safety of the combination was evaluated in a randomized, double-blinded trial in 714 patients with untreated metastatic melanoma.
The study was named RELATIVITY-047 (Table 1). Table 1. RELATIVITY-047 study (Adapted from USFDA) Table 2 represents the prescriptive details of the drug…
