The EMA has recommended extending the indication of Zynyz (retifanlimab) to the treatment of adult patients with squamous cell carcinoma of the anal canal (SCAC) who cannot undergo curative procedures.[4] Retifanlimab is a monoclonal antibody that blocks the PD-1 receptor on immune cells, preventing the cancer from suppressing the immune system and allowing it to attack the cancer cells.[3][4] Response to treatment was assessed in the main study of 94 previously treated patients whose cancer had metastasized and had not responded to platinum chemotherapy.[4] The study did not compare Zynyz with other drugs.[4] Retifanlimab was granted orphan drug status for the treatment of anal cancer on October 19, 2020.[4] Treatment must be initiated and managed by a physician experienced in oncology.[3] In the US, Zynyz was approved by the FDA in combination with carboplatin and paclitaxel as first-line immunotherapy for advanced SCAC that has relapsed or metastasized.[2][6] It can also be used as monotherapy in patients who have failed previous platinum chemotherapy.[6]