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 MKKGYPfizer 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.
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