Posted by Michael Wonder on 23 Mar 2023
FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma
22 March 2023 - Today the FDA granted accelerated approval to retifanlimab-dlwr (Zynyz, Incyte) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.
Safety and efficacy were evaluated in PODIUM-201, an open-label, multi-regional, single-arm study evaluating 65 patients with metastatic or recurrent locally advanced Merkel cell carcinoma who had not received prior systemic therapy for advanced disease.
