FDA Panel Votes to Defer Decision on Retifanlimab for Anal Cancer Retifanlimab is an investigational intravenous PD-1 inhibitor. (Credit: Getty Images.)
The Food and Drug Administration (FDA)âs Oncologic Drugs Advisory Committee (ODAC) voted 13 to 4 to defer a regulatory decision on retifanlimab, an investigational PD-1 inhibitor for locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC), until further data from a confirmatory trial are made available.
The Biologics License Application (BLA) submission for retifanlimab included data from an open-label, single-arm phase 2 trial (POD1UM-202; ClinicalTrials.gov Identifier: NCT03597295), which evaluated retifanlimab in 94 adults with locally advanced or metastatic SCAC who progressed after platinum-based chemotherapy.
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Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy.
The BLA submission is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, standard platinum-based chemotherapy. The trial enrolled 94 patients, including several with well-controlled human immunodeficiency virus (HIV) infection. The study, which was recently presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, resulted in an objective response rate (ORR) of 14% for retifanlimab monotherapy as determine