The first line swings it for Zynyz

Incyte's latecomer anti-PD-1 drug Zynyz has carved out two more niche US approvals, in squamous cell carcinoma of the anal canal (SCAC) – one as a first-line chemo combo and the other as monotherapy for relapsed patients. Clearly the FDA's decision was driven by data from the first-line Pod1um-303 study, presented at last year's ESMO. Incyte had first tried to get Zynyz greenlit for relapsed SCAC way back in 2021, but an adcom ruled that the uncontrolled Pod1um-202 study was insufficient to back an accelerated approval, and that a decision should be deferred pending data from Pod1um-303; a CRL followed. It's notable that the drug's updated label cites the same Pod1um-202 data as before, and both the new green lights are full, not accelerated. It's also interesting that Pod1um-303 has only provided backing in terms of PFS, as the interim OS endpoint remains numerically positive but statistically non-significant, as was revealed at ESMO. In February Incyte said it had submitted Zynyz for SCAC two months previously; the drug's first approval, for Merkel cell carcinoma, came out of the blue, nothing having been disclosed about filing.

Approved US indications for Zynyz

Notes: SCAC=squamous cell carcinoma of the anal canal; AA=accelerated approval. Source: OncologyPipeline.