1. Scrip

Incyte’s US Approval For PD-1 Inhibitor Zynyz In MCC Draws Muted Response

Unlikely To Prove Competitive

 
• By Ayisha Sharma

The US firm’s Zynyz has won accelerated approval for the treatment of first-line Merkel cell carcinoma, bouncing back from a prior regulatory setback, but its third-to-market status leaves it with the crumbs under the table in this orphan indication.  

Wooden background with three drawn emoticon images in middle: sad, neutral and happy. Hand reaching out to place neutral emoticon.
The Approval Milestone Was Met With A Neutral Response • Source: Shutterstock

Incyte Corporation’s PD-1 inhibitor, retifanlimab, has won a US approval in first-line Merkel cell carcinoma (MCC) under the brand name Zynyz, but analysts are unimpressed by its commercial potential given the availability of more competitive products and the rarity of MCC, ahead of approvals in other indications.

The US Food and Drug Administration approved Zynyz under an accelerated pathway based on tumor response rate and duration of response (DOR) data, but its continued approval will depend on

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