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    DRUG:

    luvometinib (FCN-159)

    i
    Other names: FCN-159, FCN 159, FH1701
    Company:
    Fosun Pharma
    Drug class:
    MEK1 inhibitor, MEK2 inhibitor
    Related drugs:
    1m
    A single center, single arm, prospective clinical study initiated by a researcher on the efficacy and safety of FCN-159 table (ChiCTR2500109679)
    P=N/A, N=20, Completed, Beijing Childrens Hospital,Capital Medical University; Beijing Childrens Hospital,Capital Medical University
    New trial
    |
    luvometinib (FCN-159)
    1m
    Phase 1 Study of Luvometinib Use in Pediatric Patients with Neurofibromatosis Type 1-Related Unresectable Plexiform Neurofibromas. (PubMed, Target Oncol)
    Luvometinib had a manageable safety profile in pediatric patients with unresectable NF1-related PN. Encouraging preliminary efficacy was observed, particularly among patients receiving the RP2D of 5 mg/m2, supporting further investigation of luvometinib in this setting.
    P1 data • Journal
    |
    NF1 (Neurofibromin 1)
    |
    luvometinib (FCN-159)
    4ms
    Luvometinib: First Approval. (PubMed, Drugs)
    In May 2025, luvometinib was approved in china for the treatment of adult patients with Langerhans cell histiocytosis (LCH) and histiocytic neoplasms and for the treatment of paediatric patients aged ≥ 2 years with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. This article summarizes the milestones in the development of luvometinib leading to this first approval for the treatment of adult patients with LCH/histiocytic tumours and children and adolescents aged ≥ 2 years with NF1 with symptomatic, inoperable PN.
    Journal
    |
    NF1 (Neurofibromin 1)
    |
    Ivesa (firmonertinib) • luvometinib (FCN-159)
    4ms
    Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors (clinicaltrials.gov)
    P2, N=30, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting --> Recruiting
    Enrollment open
    |
    luvometinib (FCN-159)
    6ms
    Follow-up Study to Evaluate the Safety and Efficacy of FCN-159 in Pediatric Participants With Neurofibromatosis Type 1 (clinicaltrials.gov)
    P1/2, N=65, Not yet recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
    New P1/2 trial
    |
    Ivesa (firmonertinib) • luvometinib (FCN-159)
    6ms
    FCN-159 Monotherapy Versus Chemotherapy by Investigator's Choice in Pediatric Low-grade Glioma Patients With BRAF Alteration (clinicaltrials.gov)
    P3, N=102, Not yet recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
    New P3 trial
    |
    BRAF (B-raf proto-oncogene)
    |
    carboplatin • temozolomide • Ivesa (firmonertinib) • luvometinib (FCN-159) • vindesine
    8ms
    An Exploratory Study to Evaluate the Efficacy and Safety of FCN-159 in Patients With Brain Arteriovenous Malformations (clinicaltrials.gov)
    P2, N=10, Recruiting, Xuanwu Hospital, Beijing
    New P2 trial
    |
    luvometinib (FCN-159)
    8ms
    FCN-159-008: A phase II multicenter, open-label, single-arm study to evaluate the efficacy and safety of FCN-159 in adolescent and adult patients with extracranial arteriovenous malformation (ChiCTR2500096055)
    P2, N=35, Not yet recruiting, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; Shanghai Fosun Pharmaceutical (Group) Limited by Shar
    New P2 trial
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • PTEN (Phosphatase and tensin homolog) • MAP2K1 (Mitogen-activated protein kinase kinase 1) • SMAD4 (SMAD family member 4) • MAP2K2 (Mitogen-activated protein kinase kinase 2) • EPHB4 (EPH receptor B4) • RASA1 (RAS P21 Protein Activator 1)
    |
    luvometinib (FCN-159)
    9ms
    FCN-159 in Adult Patients with Symptomatic, Inoperable Neurofibromatosis Type 1-Related Plexiform Neurofibromas (clinicaltrials.gov)
    P3, N=167, Active, not recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    NF1 (Neurofibromin 1)
    |
    luvometinib (FCN-159)
    11ms
    To Evaluate the Efficacy, Safety, and PK Characteristics of FCN-159 in Pediatric Patients With Refractory/Recurrent LCH (clinicaltrials.gov)
    P2, N=56, Recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Trial completion date: Jul 2026 --> May 2027 | Trial primary completion date: Jul 2024 --> May 2025
    Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog) • MAP2K1 (Mitogen-activated protein kinase kinase 1) • MAP2K2 (Mitogen-activated protein kinase kinase 2) • ARAF (A-Raf Proto-Oncogene)
    |
    luvometinib (FCN-159)
    1year
    Study to Evaluate the Safety, Tolerability, PK Characteristics and Anti-tumor Activity of FCN-159 in Adult and Pediatric Participants With Neurofibromatosis Type 1 (clinicaltrials.gov)
    P1/2, N=160, Active, not recruiting, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Phase classification: P2 --> P1/2
    Phase classification
    |
    NF1 (Neurofibromin 1)
    |
    NF1 mutation
    |
    luvometinib (FCN-159)
    1year
    A single-center, open, single-arm phase II clinical study: evaluation of the efficacy and safety of FCN-159 in selected NF2-associated nerve sheath tumors (ChiCTR2400086826)
    P2, N=30, Not yet recruiting, Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences
    New P2 trial
    |
    luvometinib (FCN-159)