Regeneron Pharmaceuticals, Inc. (REGN) on Tuesday said its supplemental biologics license application for Libtayo for the treatment of patients with advanced cervical cancer has been accepted by the Food and Drug Administration for priority review.
A decision by the FDA is expected on January 30, 2022.
The sBLA is supported by results from a Phase 3 study, dubbed EMPOWER-Cervical 1, that investigated Libtayo monotherapy versus chemotherapy in patients with recurrent or metastatic cervical cancer who had progressed on platinum-based chemotherapy.
The sBLA is also being reviewed under the FDA's Project Orbis initiative, that allows for concurrent review by participating health authorities in Australia, Brazil, Canada and Switzerland, Regeneron said.
Additional global regulatory submissions, including in the European Union (EU), are expected by the end of 2021.
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