The U.S. Food and Drug Administration (FDA) has received accelerated approval for Zynyz (retifanlimab-dlwr), afor the treatment of adults with a rare form of skin cancer,- etastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
The Biologics License Application (BLA) for Zynyz has been approved under accelerated approval by the U.S. FDA based on tumor response rate and duration of response Continued approval of Zynyz for this indication may be based on verification and description of clinical benefit in trials.
Metastatic or recurrent locally advanced Merkel cell carcinomaMCC is a rare and aggressive type of skin cancer that frequently appears as a single, painless, reddish-purple skin nodule on the head, neck and arms in skin exposed to sunlight.. MCC tends to grow quickly and has a high rate of metastatic disease, leading to a poor prognosis.. MCC impacts less than 1 per 100,000 people in the U.S., but incidence rates are rapidly rising, especially in adults over the age of 65..
“More than a third of patients with MCC present with regional or distant metastases, which are associated with high rates of mortality,” said Dr. Shailender Bhatia, University of Washington and Fred Hutchinson Cancer Center. “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.”
The FDA approval was based on data from a small scale trial.
“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,” said Hervé Hoppenot, CEO, Incyte. “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.”
Financial assisrance is available for those needing access to the drug. More information is available by visiting www.incytecares.com.
For more information about the study that led to FSA’s decision, visit: https://clinicaltrials.gov/ct2/show/NCT03599713.
Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.
Incyte is based near Wilmington.