| Abstract: |
The FDA has granted retifanlimab-dlwr (Zynyz) accelerated approval for the treatment of patients with metastatic or recurrent, locally advanced merkel cell carcinoma (MCC). The prescribing label comes with warnings for immune-mediated adverse events (AEs), infusion-related reactions, allogeneic hematopoietic stem cell transplant complications, and embryo-fetal toxicity. Continued approval will be contingent upon confirmatory trials.1,2 Data from the POD1UM-201 trial (NCT03599713) supported the FDA's decision... |
