La crème Ruxolitinib (Opzelura) a reçu l'approbation de la FDA (septembre 2022) pour...
Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.
| ID | BMA-JAK3-CTCL |
|---|---|
| Type | Pertinence thérapeutique |
| État | reviewed 2026-05-04 | pending_clinical_signoff | actionability review required |
| Maladies | DIS-MF-SEZARY |
| Sources | SRC-ESMO-CTCL-2024 |
Faits relatifs à l ' action en justice
| Biomarqueur | BIO-JAK3 |
|---|---|
| Variante | mutation activante JAK3 — mycose fungoides (MF) ou syndrome de Sézary (SS); hyperactivation de la voie JAQ/STAT; ruxolitinib approuvé pour MF/SS indépendamment du statut JAJ3 |
| Maladie | DIS-MF-SEZARY |
| Niveau ESCAT | IIA |
| Combinaisons recommandées | ruxolitinib 20 mg PO BID — investigational for JAK3/JAK1-altered MF/SS; no approved CTCL indication for oral ruxolitinib, mogamulizumab 1 mg/kg IV weekly ×4 then q2w — FDA-approved for relapsed/refractory MF/SS (CCR4-targeted; JAK3-independent), brentuximab vedotin 1.8 mg/kg IV q3w — FDA-approved for CD30+ MF (CD30 ≥10% by IHC; JAK3-independent) |
| Résumé des faits | Ruxolitinib cream (Opzelura) received FDA approval (September 2022) for mild-to-moderate atopic dermatitis; separately, ruxolitinib phosphate (Jakafi, oral) is FDA-approved for steroid-refractory acute/chronic GVHD but NOT specifically approved for CTCL as of 2026. However, the JAK/STAT pathway is aberrantly activated in MF/SS (~30–50% have JAK3 mutations or JAK1/STAT3/STAT5 alterations), making JAK inhibitors an active investigational area. Phase II evidence: ruxolitinib (oral) ORR ~29% in relapsed/refractory MF (RUXO-MF pilot data); itacitinib (JAK1 inhibitor) and cerdulatinib (JAK/SYK inhibitor) in phase II trials for CTCL. The CTCL-specific approvals are for non-JAK-targeted agents: romidepsin (HDAC inhibitor; FDA 2009 CTCL), brentuximab vedotin (CD30+; FDA 2017), mogamulizumab (CCR4; FDA 2018), vorinostat (FDA 2006). JAK3-mutant CTCL: JAK3 mutation identifies a subset with stronger a priori rationale for JAK inhibitor use; ESCAT IIA reflects absence of dedicated FDA approval in CTCL despite biological rationale and early phase data. |
Notes
ESCAT IIA: JAK3 mutation enriches for JAK inhibitor sensitivity in CTCL; no FDA-approved JAK inhibitor for oral CTCL use as of 2026. Clinical decision: JAK3 testing in MF/SS informs trial eligibility for JAK inhibitor basket trials; does not currently change standard therapy sequence. Standard sequence for MF/SS: skin-directed therapy (topical steroids, phototherapy PUVA/UVB) → bexarotene → mogamulizumab or brentuximab vedotin (CD30+) → romidepsin → clinical trial (including JAK inhibitor trials for JAK-altered disease). Itacitinib (JAK1-selective) and cerdulatinib (JAK/SYK) have phase II CTCL data; watch for label updates. Note: mogamulizumab is CCR4-targeted (not JAK3-specific) and is FDA-approved for R/R MF/SS regardless of JAK3 status.
Utilisé par
No reverse references found in the YAML corpus.