Fenebrutinib

Latest news on fenebrutinib

30 September 2026
Roche’s fenebrutinib accepted for FDA priority review for RMS and PPMS

Phase III data showed ARR reductions of 51% and 58% vs teriflunomide and a numerical 12% reduction in PPMS progression versus ocrelizumab; CNS‑penetrant, non‑covalent BTK inhibitor.

21 April 2026
Roche’s fenebrutinib halves RMS relapse rate to ~1 per 17 years

FENhance 1/2: the BTK inhibitor cut MRI lesion activity vs teriflunomide and showed trends to less disability; PPMS trial non‑inferior to ocrelizumab. Safety: similar LFTs; more deaths.

1 March 2026
Genentech's Fenebrutinib Shows Promise as BTK Inhibitor for MS in Phase III Study

Fenebrutinib reduced relapses by 51% in RMS, consistent with prior studies. Data will be submitted to regulators. Safety profile comparable to teriflunomide; further analysis on fatalities ongoing.