Ojemda (tovorafenib) — what has changed
· update, 10 Sep 2026
Servier now holds two RAF-directed programmes — Ojemda and
BDTX-4933/S241656 — alongside vorasidenib. On the regulatory record: an
efficacy supplement approved 27 August 2025 did not convert Ojemda to full
approval; the label gained a growth-velocity warning (5.4) aimed at
its paediatric population, and carries a warning of increased tumour growth
in BRAF-wild-type NF1 models (5.6). Confirmatory trial NCT05566795 reads out
June 2027.
Read the update
📌 Recurring · Weekly Competitive Intelligence — Plixorafenib landscape
Mission: keep the plixorafenib competitive landscape continuously current, visible, and trustworthy — a living, cited, repeatable resource, never scattered or rebuilt ad hoc. Every week, a what-changed delta-scan runs across the tracked competitors (readouts, label changes, confirmatory data, safety, approvals, earnings, new entrants), refreshing each dossier’s data-cut and flagging material changes for sign-off; a full rebuild follows SNO / ASCO / EHA readouts, label changes, and earnings. Competitor data is public + cited; plixorafenib’s own figures stay Fore-internal and are never fabricated.
Updated 20 Jul 2026. The tovorafenib dossier goes from 8 to 14 sections, answering the slide-review
items: development trajectory beyond FIREFLY, label age scope, the ORR-primary endpoint, guideline
positioning, commercial field infrastructure, and KOL perception.
Two corrections worth knowing: the label has no upper age limit in either the FDA or EMA
indication — “up to 25” is FIREFLY-1 trial eligibility, not label text — and
CONNECT TarGeT-B is not a Day One study (NCT07206849, sponsored by Nationwide Children’s,
readout not before May 2030).
New alongside it: an age-specific incidence and outcome report for four CNS histologies, whose
headline is that only pilocytic astrocytoma can honestly be charted.
Plixorafenib comparison cells remain Fore-internal placeholders pending cleared data.
No studies yet. Click New Study to capture one.