Incyte and Syndax Receives US FDA Approval for Niktimvo (axatilimab-csfr) to Treat Chronic Graft-Versus-Host Disease (GvHD)
Shots:
- Based on P-II (AGAVE-201) study, Niktimvo got FDA approval to treat chronic GvHD patients who failed at least two lines of previous therapy
- Niktimvo patients (0.3 mg/kg, Q2W, n=79) achieved 75% ORR in 6mos. with 1.5mos. mToR; 60% maintained response at 12mos. Study also met key exploratory EPs, 56% patients achieved ≥7-point improvement in mLSS score; 44% shown SAEs
- Both companies will co-commercialize Niktimvo in US, whereas Incyte has exclusive commercial rights outside the US. Companies plan to seek approval for two smaller Niktimvo vials following the US FDA approval (50mg size), anticipated US launch in early Q1'25
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