FDA approves Incyte skin cancer drug

March 23, 2023

Incyte announced this week that the FDA has approved its drug, to be sold as Zynzy, for the treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

MCC, a rare and aggressive form of skin cancer, tends to grow quickly and often spreads to other parts of the body. The five-year survival rate for patients with MCC who present with distant metastasis is estimated to be only 14%.

Zynyz is an anti-PD-1 medication, a type of medication that works by blocking the PD-1 pathway, typically used by cancer cells to evade the immune system. 

The accelerated approval hinged on results from the POD1UM-201 trial, which enrolled patients with MCC who had not yet received prior systemic therapy. From the cohorts, 12 patients were seen to have complete response, and 22 patients showed partial response. 

The drug was initially developed by MacroGenics, and the company is set to receive a $15 million milestone payment from Incyte. The two signed a licensing and collaboration agreement in 2017.