Incyte has announced FDA approval of Zynyz
pharmafile | March 23, 2023 | News story | Medical Communications |
Incyte has today announced that the FDA gas approved Zynyz (retifanlimab-dlwr) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). The drug is a humanised monoclonal antibody which targets programmed death receptor-1 (PD-1).
The Biologics License Application (BLA) for this drug for treating MCC receives its approval under the FDA’s accelerated approval program, based on tumour response rate and duration of response (DOR). Further verification and confirmation of clinical benefit from subsequent clinical trials may be required to ensure the continued approval of Zynyz.
This approval follows promising data from the POD1UM-201 trial, which evaluated Zynyz in adult patients with metastatic or recurrent locally advanced MCC who had not previously received systemic therapy for their advanced disease.
Dr Shailender Bhatia, from the University of Washington and Fred Hutchinson Cancer Center, commented: “More than a third of patients with MCC present with regional or distant metastases, which are associated with high rates of mortality. The approval of Zynyz offers healthcare providers another first-line treatment option against MCC that can result in durable responses in patients with metastatic disease, and I look forward to having Zynyz in our treatment portfolio for these difficult-to-treat patients.”
Hervé Hoppenot, CEO of Incyte, added: “Zynyz offers patients and healthcare professionals an additional first-line anti-PD-1 option for patients with metastatic or recurrent locally advanced MCC, which can be a challenging and aggressive disease to treat. Incyte is grateful to the investigators and patients around the world who participated in the POD1UM-201 trial. We continue to study the potential of Zynyz in additional tumor types and in combination with other Incyte pipeline compounds.”