USA — Incyte’s Zynyz (retifanlimab-dlwr) has received accelerated approval from the FDA for the treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in adults.

MCC is a rare type of skin cancer that grows rapidly and is often accompanied by a high incidence of metastasis, resulting in poor prognoses.

Although it is about 40 times rarer than melanoma, incidence rates are increasing, particularly among older adults, according to the Skin Cancer Foundation.

While the five-year overall survival rate is only 14% for patients with MCC with distant metastatic disease, incidence rates are rapidly increasing, particularly in adults over the age of 65, with less than 1 in 100,000 people in the United States affected by MCC.

Incyte provides patient access and financial assistance through its program, IncyteCARES.

MacroGenics licensed Zynyz to Incyte in exchange for US$150 million upfront for worldwide rights. Upon receiving its initial approval, Incyte will make a US$15 million milestone payment to MacroGenics.

Additional development and regulatory milestones could total up to US$320 million, and commercialization milestones could add another US$330 million.

The FDA granted accelerated approval based on the results of an ongoing single-arm study, POD1UM-201, which showed a 52% response rate and an 18% complete response rate among Zynyz patients with no prior treatment.

While response duration varied from 1.1 months to more than 24.9 months, 62% of patients had a response lasting one year or more.

Zynyz is a humanized monoclonal antibody that targets programmed death receptor-1 (PD-1), the same target as Merck’s Keytruda and Merck KGaA and Pfizer’s Bavencio, both approved for the treatment of MCC.

The list price for Keytruda, given every six weeks, is US$21,367.04, while the list price for each dose given every three weeks is US$10,683.52.

According to an Incyte spokesperson, Zynyz’s price will be comparable to that of other agents in the same class currently available in the market.

This approval provides patients with another option for the treatment of MCC, a disease with limited treatment options.

The competition between these drugs will help drive down the costs of treatment and may lead to further innovation in the field.

By expanding treatment options, patients with MCC have a better chance of survival and improved quality of life.

Incyte is also seeking approval for a combination treatment with platinum-based chemotherapy in small cell lung cancer and squamous cell carcinoma of the head and neck.

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