Fumaining (luvometinib) / Fosun Pharma, Fochon Pharmaceuticals - LARVOL DELTA

A Single-Center, Cohort Study of Luvometinib in Patients with Neurofibromatosis Type 1-Associated Plexiform Neurofibromas and Unidentified Bright Objects (ESMO 2026) - No abstract available

Clinical • Oncology • Solid Tumor

A Phase 2 Study of Luvometinib Combined With Anlotinib in KRAS-mutated NSCLC (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Luvometinib in adults with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas: A randomized, double-blind, placebo-controlled, phase 3 trial. (ASCO 2026) - P3 | "Our study demonstrated that luvometinib achieved a statistically significant ORR per BIRC compared with placebo, with rapid and durable response, significant reductions in pain severity, and an overall manageable safety profile. These findings suggest that luvometinib may emerge as a new standard treatment for patients with NF1 and symptomatic, inoperable PNs."

Clinical • P3 data • Genetic Disorders • Neurofibromatosis • Solid Tumor • NF1

LUCAS: Response-adapted Luvometinib With or Without Cytarabine in Langerhans Cell Histiocytosis (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Monotherapy • New P2 trial • Langerhans Cell Histiocytosis

Platform Research for Innovative Medicines in NF2-SWN (PRIME-NF2) (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital

New P2 trial • Brain Cancer • Ependymoma • Genetic Disorders • Meningioma • Neurofibromatosis • Oncology • Solid Tumor

Luvometinib in Combination With Serplulimab for NF2-Related Tumors (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Beijing Tiantan Hospital

New P1/2 trial • Brain Cancer • Genetic Disorders • Meningioma • Neurofibromatosis • Oncology • Solid Tumor

CLINICAL CHARACTERISTICS, TREATMENT OUTCOMES, AND GENETIC PROFILING OF LANGERHANS CELL HISTIOCYTOSIS: A SINGLE-CENTER RETROSPECTIVE STUDY OF 202 PEDIATRIC PATIENTS (EHA 2026) - "First-line vincristine/prednisone-based therapy in 178 patients yielded complete/partial response (AD-B/AD-S) in 134 (75.3%). Targeted therapy (dabrafenib/trametinib) was administered to 56 patients, primarily those with BRAF V600E or MAP2K1 mutations or refractory disease. Disease progression or suboptimal response prompted second-line therapy (cytarabine, cladribine, clofarabine, or FCN-159) in 64 patients...Summary/Conclusion This large pediatric LCH cohort demonstrates diverse clinical presentation and underscores the prognostic and therapeutic relevance of genetic profiling. Risk-stratified and mutation-directed treatment strategies enable favorable long-term remission in most patients, supporting the integration of early molecular testing into routine clinical management to optimize outcomes."

Retrospective data • Hematological Malignancies • Langerhans Cell Histiocytosis • Pediatrics • BRAF • MAP2K1

LUVOMETINIB IN RECURRENT/REFRACTORY PEDIATRIC LANGERHANS CELL HISTIOCYTOSIS: A PHASE 2 TRIAL (EHA 2026) - P2 | "Patient- and parent-reported HRQoL showed consistent improvements from baseline. Summary/Conclusion Luvometinib demonstrated profound, genotype-agnostic efficacy and a manageable safety profile in recurrent/refractory pediatric LCH, supporting its potential as a novel salvage therapy."

Clinical • P2 data • Langerhans Cell Histiocytosis • Pediatrics • BRAF

Fosun Pharma announced that its self-developed MEK 1/2 selective inhibitor Luvometinib Tablets (trade name: Fumaining) has been officially approved by the National Medical Products Administration (the 'NMPA') for the treatment of pediatric patients 2 years of age and older with relapsed or refractory Langerhans cell histiocytosis (LCH) after systemic therapy (Fosun Pharma Press Release) - "The latest data from the Phase II study of Fumaining for the treatment of relapsed/refractory pediatric Langerhans cell histiocytosis (LCH) was successfully selected for an oral presentation at the 2026 European Hematology Association (EHA) Annual Congress."

China approval • Langerhans Cell Histiocytosis

A phase 2 study of the MEK1/2 inhibitor luvometinib in patients with extracranial arteriovenous malformations. (PubMed, Clin Cancer Res) - "In the first clinical trial of targeted therapy in adults with inoperable or relapsed extracranial AVMs, luvometinib demonstrated promising efficacy and tolerability, supporting its further development for the treatment of AVMs."

Journal • P2 data • Cardiovascular • CNS Disorders • Giant Cell Arteritis • EPHB4 • RASA1

MATCHING-ADJUSTED INDIRECT COMPARISON OF LUVOMETINIB VERSUS SELUMETINIB IN THE TREATMENT FOR PEDIATRIC PATIENTS WITH NEUROFIBROMATOSIS TYPE 1 IN CHINA (ISPOR 2026) - P1/2 | "The MAIC results indicated no significant difference in response or survival outcomes. However, luvometinib demonstrated comparable or superior safety for most grade ≥ 3 TRAEs compared to selumetinib, except for a higher rate of folliculitis."

Clinical • Dermatitis • Genetic Disorders • Immunology • Neurofibromatosis • Pediatrics • Solid Tumor

The Phase III study data of luvometinib tablets for adult patients with neurofibromas type 1 (NF1) with symptomatic, inoperable plexiform neurofibromas (PN) was selected for a rapid oral abstract session at 2026 ASCO, the study results will be released for the first time during the meeting. (The Manila Times)

P3 data • Neurofibromatosis • Oncology

A Phase 2 Study of Luvometinib Combined With Anlotinib in KRAS-mutated NSCLC (clinicaltrials.gov) - P2 | N=48 | Not yet recruiting | Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Fosun Pharma’s subsidiary obtained NMPA approval to begin a Phase II trial of its self-developed drug Luvometinib with Anlotinib in KRAS-mutant advanced non-small cell lung cancer. (India Today) - "The new trial will test Luvometinib in combination with Anlotinib for treating patients with KRAS-mutant advanced non-small cell lung cancer, with the company planning to initiate a Phase II study in mainland China, reinforcing its push into innovative oncology therapies and potentially enhancing its competitive position in targeted cancer treatments."

New P2 trial • Non Small Cell Lung Cancer

Modified LCH-III Regimen With or Without Luvometinib for Multisystem Pediatric Langerhans Cell Histiocytosis (clinicaltrials.gov) - P=N/A | N=120 | Recruiting | Sponsor: West China Second University Hospital

New trial • Langerhans Cell Histiocytosis • Pediatrics

Fosun Pharma Wins Priority Review in China for New Luvometinib Indication (TipRanks) - "The filing seeks an additional indication for treating adult patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that cannot be completely resected, expanding on Luvometinib’s existing approved uses in China."

China filing • Priority review • Neurofibromatosis • Oncology

Application Demonstration Program of Luvometinib for Pediatric and Adolescent Patients Aged 2 Years and Older with Symptomatic, Unresectable Plexiform Neurofibromas (PN) Associated with Neurofibromatosis Type 1 (NF1)(Demonstration project for the application of luvometinib in the treatment of neurofibromatosis type 1(rare disease)) (ChiCTR) - P4 | N=100 | Not yet recruiting | Sponsor: Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Ninth People's Hospital, Shanghai Jiao Tong University Sc

New P4 trial • Genetic Disorders • Neurofibromatosis • Pediatrics • Rare Diseases • Solid Tumor • NF1

Luvometinib in Pediatric SS-LCH With Special-site Single/Multifocal Bone Lesions (clinicaltrials.gov) - P=N/A | N=62 | Recruiting | Sponsor: West China Second University Hospital

Monotherapy • New trial • Langerhans Cell Histiocytosis • Pediatrics

Shanghai Fosun Pharmaceutical announced that its subsidiary’s drug registration application for Luvometinib Tablets, intended for treating pediatric patients with Langerhans cell histiocytosis, has been accepted by China’s National Medical Products Administration and prioritized for review. (TipRanks)

China filing • Priority review • Langerhans Cell Histiocytosis

A single center, single arm, prospective clinical study initiated by a researcher on the efficacy and safety of FCN-159 table (ChiCTR) - P=N/A | N=20 | Completed | Sponsor: Beijing Childrens Hospital,Capital Medical University; Beijing Childrens Hospital,Capital Medical University

New trial • Genetic Disorders • Neurofibromatosis • Pediatrics • Solid Tumor

Update on the phase II study: to explore the efficacy and safety of luvometinib (FCN-159) in recurrent or progressive pediatric low-grade glioma with MAPK pathway-activated (ESMO 2025) - P2 | "Table: 661MO Efficacy Evaluable set (ES) FCN-159 (n=37) KIAA1549-BRAF (n=23) BRAF V600E (n=11) NF1 mut (n=3) Total (n=37) Confirmed ORR (CR+PR+MR), n(%) 10 (43.5) 8 (72.7) 2 (66.7) 20 (54.1) Median DOR, months [95% confidence interval (CI)] - (-, -) - (9.232, -) - (-, -) - (14.850, -) Median PFS, months (95% CI) - (-, -) - (11.072, -) - (-, -) - (17.511, -) Median Time to Response (TTR), months (range) 3.710 (1.84, 11.17) 1.890 (1.71, 11.07) 2.695 (1.87, 3.52) 3.595 (1.71, 11.17) Safety Full analysis set (FAS) FCN-159 (n=38) Any grade TEAEs, n(%) 37 (97.4) ≥ grade 3 TEAEs, n(%) 7 (18.4) TEAEs Leading to dose interruption, n(%) 27 (71.1) TEAEs Leading to dose reduction, n(%) 0 TEAEs Leading to discontinuation, n(%) 0 Conclusions The updated data showed that FCN-159 exhibited promising efficacy for pLGG with a manageable safety profile and no new safety signal observed. A phase III randomized controlled trial to evaluate FCN-159 in pLGG is recruiting."

Clinical • P2 data • Brain Cancer • Glioma • Oncology • Solid Tumor • BRAF • KIAA1549 • NF1

Phase 1 Study of Luvometinib Use in Pediatric Patients with Neurofibromatosis Type 1-Related Unresectable Plexiform Neurofibromas. (PubMed, Target Oncol) - P1/2 | "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."

Journal • P1 data • Genetic Disorders • Neurofibromatosis • Oncology • Pain • Pediatrics • Solid Tumor • NF1

Luvometinib in patients with Langerhans cell histiocytosis, Erdheim-Chester disease, and other histiocytic neoplasms: a single-arm, multicentre, phase 2 study. (PubMed, EClinicalMedicine) - P2 | "Luvometinib demonstrated high and durable responses and a manageable safety profile in patients with histiocytic neoplasms. Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd."

Journal • P2 data • Dyslipidemia • Hematological Disorders • Hypertriglyceridemia • Langerhans Cell Histiocytosis • Oncology • Rare Diseases

Shanghai Fosun Pharmaceutical (Group) Co., Ltd…announced that its self-developed innovative drug Luvometinib Tablets has gained Breakthrough Therapy Designation by the Saudi Food and Drug Authority (SFDA) for the treatment of adult patients with Langerhans cell histiocytosis (LCH) and histiocytic neoplasms. (Market Screener)

Breakthrough therapy • Langerhans Cell Histiocytosis

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 • Genetic Disorders • Langerhans Cell Histiocytosis • Neurofibromatosis • Oncology • Pediatrics • Rare Diseases • Solid Tumor • NF1