Incyte Would Now Compete With Merck, Pfizer As Its Skin Cancer Treatment Scores FDA Accelerated Approval

The FDA granted accelerated approval to Incyte Corporation's INCY Zynyz (retifanlimab-dlwr) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).
Continued approval of Zynyz for this indication may be contingent on verification and description of clinical benefit in confirmatory trials.
Also Read: Analyst Writes Incyte's Opzelura Provides Deepening, Relapse Prevention; Povo Data Intriguing In Depigmented Skin Disorder.
MCC 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.
The FDA approval was based on data from the POD1UM-201 trial.
Among chemotherapy-naïve patients (n=65), Zynyz monotherapy resulted in an objective response rate (ORR) of 52%.
Complete response was seen in 12 patients (18%), and 22 patients (34%) showed partial response.
Among the responding patients, the duration of response (DOR) ranged from 1.1 to 24.9+ months.
76% (26/34) experienced a DOR of six months or longer, and 62% (21/34) experienced a DOR of 12 months or longer by landmark analysis.
MacroGenics Inc MGNX developed the therapy and was licensed to Incyte in 2017.
Incyte's product competes with Merck & Co Inc's MRK Keytruda, and Merck KGaA MKGAF MKKGY & Pfizer Inc's PFE Bavencio, approved to treat MCC.
The list price for each dose of Keytruda when it is given every three weeks is $10,683.52.
Incyte said the monthly treatment price with Zynyz will be comparable with other drugs in the same class that is currently available, Reuters reported.
Price Action: INCY shares closed at $72.26 on Wednesday.