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Last update 16 Jul 2025

Dabrafenib Mesylate

Last update 16 Jul 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

dabrafenib, Dabrafenib Mesilate, Dabrafenib mesilate (JAN)

+ [18]

Target

BRAF x CRAF

Action

inhibitors

Mechanism

BRAF inhibitors(Serine/threonine-protein kinase B-raf inhibitors), CRAF inhibitors(C-Raf kinase inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [6]

Active Indication

BRAF Fusion GliomaBRAF mutation positive hairy cell leukemiaBRAF mutation Solid Tumors+ [25]

Inactive Indication

Bile Duct NeoplasmsBRAF Mutation AmeloblastomaBRAF V600 mutation low-grade glioma+ [25]

Originator Organization

GSK Plc

Active Organization

Novartis Pharmaceuticals Corp.Novartis Europharm Ltd.

Beijing Novartis Pharma Co. Ltd.

+ [6]

Inactive Organization

Novartis Pharmaceuticals Canada, Inc.

JS InnoPharm (Shanghai) Co., Ltd.

GlaxoSmithKline (China) Investment Co., Ltd.

+ [2]

License Organization

Novartis AG

GSK Plc

Drug Highest PhaseApproved

First Approval Date

United States (29 May 2013),

BRAF V600E Mutation-Positive Melanoma

RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Australia), Priority Review (China)

Structure/Sequence

Molecular FormulaC24H24F3N5O5S3

InChIKeyYKGMKSIHIVVYKY-UHFFFAOYSA-N

CAS Registry1195768-06-9

181

Clinical Trials associated with Dabrafenib Mesylate

NCT07010393

/ Not yet recruitingPhase 4IIT

A Multicenter Prospective-Retrospective Real-World Study Evaluating Conversion-to-Surgery and Survival After Genotype-Matched Neoadjuvant Systemic Therapy in Locally Advanced Thyroid Carcinoma

This multicenter registry tests whether genomically matched neoadjuvant therapy (1-4 cycles tailored to BRAF V600E, RET fusion/mutation, isolated TERT mutation, triple-negative BRAF/RET/TERT, or ICI ± TKI) can render locally advanced, initially unresectable-or high-morbidity-thyroid cancers operable. The primary endpoint is conversion-to-surgery; key secondaries are R0/1 margin rate and 12-month event-free survival, with propensity-score weighting correcting cohort imbalances. Findings aim to define a precision-guided neoadjuvant standard for down-staging advanced thyroid tumors.

Start Date01 Jul 2025

Sponsor / Collaborator

Fujian Medical University

NCT07022834

/ RecruitingPhase 2IIT

A Real-world Investigation of the Combination of Darafenib or Trametinib and Clofarabine in the Treatment of High-risk, Recurrent, or Refractory Pediatric Patients With Langerhans Cell Histiocytosis.

Langerhans cell histiocytosis (LCH) is the most common histiocytosis in children, with an incidence of 2.6-8.9 per million. It is an inflammatory myeloid tumor with varied symptoms. Mild cases often resolve spontaneously, while severe cases can affect multiple organs and be life-threatening. LCH affecting the liver, spleen, or hematopoietic system has a poor prognosis and is high-risk group. The LCH-III study showed that low-risk children respond well to prednisone and vinblastine, with nearly 100% survival, but high-risk children's survival is about 80%, with a 30% reactivation rate.Long-term studies reveal that about 50% of patients are resistant to prednisone and vinblastine, leading to progression and recurrence.
Except combination of prednisone and vinblastine, cladribine (introduced in 1998) and MAPK inhibitors (introduced in 2014), have lowered the mortality rate of LCH in children. Cladribine, a nucleoside analogue, is used for treating recurrent acute myeloid leukemia in children by disrupting DNA synthesis. In the LCH-98-S regimen, low-risk children with LCH responded well to moderate doses of cladribine, but 44% of high-risk children still faced disease progression. Later studies showed that high-dose cladribine with medium-dose cytarabine increased survival in refractory LCH from 30% to 85%, but also raised chemotherapy toxicity, with some cases experiencing severe hematological toxicity and half of the deaths resulting from chemotherapy complications. Clofarabine, a nucleoside analogue, inhibits ribonucleotide reductase and DNA polymerase, offering stronger anti-tumor effects and fewer side effects than cladribine and fludarabine in treating refractory leukemia. Case reports show that LCH patients unresponsive to cladribine improve with clofarabine treatment at moderate doses (25mg/m2/day). A retrospective study of 58 LCH patients using clofarabine (25mg/m2/day) showed an 87% progression-free survival rate after one year. While the main side effect was grade 3 or higher hematological toxicity, 98.3% of patients tolerated it and completed treatment. Further prospective studies are needed to determine the optimal dose, duration, long-term efficacy, and complications of clofarabine in children with LCH.
Research indicates that childhood LCH is often linked to mutations in MAPK pathway genes, with over half of cases involving BRAFV600E mutations. MAPK inhibitors, like vemurafenib, dabrafenib and trametinib, are effective for relapsed and refractory LCH, but they don't eliminate malignant clones, leading to disease reactivation after stopping treatment. Some BRAF-deficient mutation LCH patients resist vemurafenib and dabrafenib, but trametinib can manage the disease in these cases. Activation of the MAPK pathway increases BCL2L1 expression in LCH cells, and rapamycin fails to induce apoptosis in BRAFV600E+ LCH cells, enhancing resistance to cell death. MAPK inhibitors combined with chemotherapy are theoretically more effective at inducing apoptosis in LCH cells and resetting the immune environment to eliminate malignant clones. Two clinical studies confirm their safety and efficacy in treating refractory recurrent LCH. In a follow-up of 10 LCH cases treated with nucleotide analogues and MAPK inhibitors, only 2 patients relapsed after a short treatment duration. Additionally, 19 children with BRAFV600E mutation LCH were treated with cladribine, cytarabine, and vemurafenib, achieving a 100% response rate. Nearly 80% completed treatment without recurrence, and no increase in side effects was observed.
Since 2020, our center treated nearly 40 LCH patients with MAPK inhibitors, including 14 combined with LCH-III chemotherapy. Follow-ups show no severe toxic side effects, aligning with literature. However, most high-risk patients, especially those who stopped oral MAPK inhibitors, had disease reactivation. Two high-risk patients with liver involvement achieved complete liver lesion regression with cladribine. This clinical study aims to assess the efficacy and safety of dabrafenib or trametinib and clofarabine for high-risk/recurrent/refractory LCH in children.

Start Date01 Jun 2025

Sponsor / Collaborator

West China Second University Hospital

NCT06712875

/ RecruitingPhase 1/2IIT

A Pilot Study Evaluating the Toxicity and Clinical Benefit of Mitogen-activated Protein Kinase (MAPK) Pathway Inhibition Combined With Programmed Cell Death-1 Checkpoint Blockade (Anti-PD1) for the Treatment of BRAF-altered Pediatric Gliomas

Pediatric gliomas harboring BRAF-alterations, commonly BRAFV600 mutation or KIAA1549-BRAF fusion, are currently treated with either chemotherapy or mitogen activated protein kinase (MAPK) inhibitors, such as, dabrafenib and/or trametinib. Unfortunately, some BRAF-altered gliomas can progress or have rebound growth after discontinuation of therapy. Data from BRAFV600E-mutant melanoma has shown potential synergy between MAPK inhibition and anti-programmed cell death 1 (anti-PD1) checkpoint blockade. Anti-PD1 therapy, such as, nivolumab can block the PD1 receptor on T cells, a marker of T cell exhaustion, allowing a continued or more robust anti-tumor immune response. Here, investigators will combine MAPK inhibition with anti-PD1 therapy in recurrent, refractory low grade BRAF-altered glioma and newly diagnosed or recurrent BRAF-altered or NF-altered high grade glioma.

Start Date01 Apr 2025

Sponsor / Collaborator

Ann & Robert H. Lurie Children's Hospital of Chicago

100 Clinical Results associated with Dabrafenib Mesylate

100 Translational Medicine associated with Dabrafenib Mesylate

100 Patents (Medical) associated with Dabrafenib Mesylate

2,936

Literatures (Medical) associated with Dabrafenib Mesylate

01 Dec 2025·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Identification of different lung adenocarcinoma subtypes in combination with antidiuretic hormone-related genes and creation of an associated index to predict prognosis and guide immunotherapy

Article

Author: Dai, Hong ; Lv, Yuankai ; Zheng, Hao ; Cai, Xiaoping

BACKGROUND:

Lung adenocarcinoma (LUAD) is one of the most aggressive and rapidly lethal tumor types. Previous studies have demonstrated the involvement of antidiuretic hormone (ADH)-related genes in cancer. However, the role of ADH-related genes in LUAD remains unclear. Therefore, investigating the characteristics of these genes in LUAD is essential.

METHODS:

Differentially expressed genes (DEGs) associated with ADH in LUAD were identified using the STRING database. Consensus clustering was performed, and a protein-protein interaction network was constructed for the DEGs between subtypes. Genes extracted from the PPI network underwent univariate, LASSO, and multivariate Cox regression analyses to develop a predictive model for LUAD. A nomogram integrating clinical data and risk scores was created, and its prognostic power for overall survival (OS) in LUAD patients was evaluated. Additionally, LUAD patients were analyzed for targeted therapies, immune landscape, functional enrichment, and mutation profiles. Finally, qRT-PCR was used to examine the expression of signature genes in LUAD cells.

RESULTS:

Based on ADH-related DEGs, LUAD patients were stratified into two clusters (Cluster 1 and Cluster 2) with distinct survival outcomes. A predictive model incorporating nine feature genes was subsequently constructed using DEGs from these two subtypes. The receiver operating characteristic curve demonstrated the model's prognostic accuracy in predicting OS in LUAD patients. Compared to the high-risk group, patients in the low-risk group exhibited higher immune infiltration levels and immunophenoscore, along with lower tumor immune dysfunction and exclusion scores. Enrichment analysis revealed that immune response pathways and ligand-receptor interactions were the primary functional categories distinguishing the high- and low-risk groups. The low-risk group showed a significantly lower gene mutation burden. Drug sensitivity analysis identified several potential targeted therapies, including Dabrafenib, ARQ-680, Vemurafenib, BGB-283, MLN-2480, and GDC-0994, which might act on hub genes. qRT-PCR validation confirmed that DNAH12 was significantly downregulated in tumor tissues, while DKK1, DLX2, IGFBP1, NTSR1, RPE65, and VGF were markedly upregulated.

CONCLUSION:

This study provided potential prognostic biomarkers for LUAD and might facilitate the development of effective immunotherapy strategies for LUAD patients.

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Real-world pharmacokinetics of trametinib in pediatric low-grade glioma

Article

Author: Faure-Conter, Cécile ; Guitton, Jérôme ; Ceraulo, Antony ; Philippe, Michael ; Pagnot, Laurie ; Granger, Isaline ; Leblond, Pierre ; Favier, Bertrand

PURPOSE:

Trametinib, a MEK1/2 inhibitor, has emerged as a promising treatment for pediatric patients with low-grade gliomas (LGG). However, trametinib exhibits significant inter-individual pharmacokinetic (PK) variability, and studies in adults demonstrated an exposure-efficacy relationship. This study aimed to evaluate the PK profile of trametinib in pediatric routine care and explore potential exposure-outcome relationships.

METHODS:

We analyzed PK data from 65 blood samples from 19 children receiving trametinib, either as single agent or in combination with dabrafenib. A trough concentration (Cmin) range of 8-15 ng/mL was considered, based on average exposure reported in the largest pediatric study.

RESULTS:

The mean Cmin was 8.82 ng/ml, with 64.6% of samples falling within the predefined target range, while 35.4% were below it. Regarding tolerance, 84.2% of patients experienced treatment-related toxicities, predominantly skin and subcutaneous tissue disorders. Efficacy data were limited.

CONCLUSION:

These findings underscore the necessity of therapeutic drug monitoring in pediatric patients to optimize treatment efficacy and minimize toxicity, highlighting trametinib's potential for personalized dosing strategies in this population.

01 Dec 2025·CHILDS NERVOUS SYSTEM

Efficacy and safety of dabrafenib plus trametinib in pediatric versus adult gliomas: a systematic review and meta-analysis

Review

Author: Tos, Salem M ; Kooshki, Alireza ; Najari, Dorsa ; Hajikarimloo, Bardia ; Zare, Amir Hessam ; Alvani, Mohammadamin Sabbagh ; Hasanzade, Arman ; Habibi, Mohammad Amin ; Zare, Amir Hossein

BACKGROUND:

The clinical course and therapeutic outcomes of pediatric and adult gliomas vary. Dabrafenib plus trametinib is a new therapeutic option for the management of gliomas. This study aimed to compare the outcomes of co-administration of dabrafenib and trametinib in pediatric and adult gliomas.

METHODS:

Systematic search was conducted in four electronic databases encompassing Pubmed, Embase, Scopus, and Web of Science. Publications that assessed the role of dabrafenib plus trametinib in adults or pediatrics were included.

RESULTS:

Eight studies with 243 individuals, encompassing 161 pediatrics and 82 adults, were included in our study. We demonstrated that despite a higher objective response rate (ORR) (53% [95% CI, 44-61%] vs. 39% [95% CI, 26-54%], P = 0.11) and clinical benefit rate (CBR) (87% [95% CI, 72-95%] vs. 73% [95% CI, 54-86%], P = 0.16) among pediatrics, the difference was insignificant. We exhibited that younger age, BRAF V600 mutation, and longer therapy periods were accompanied by better radiological outcomes among pediatrics, and the female gender was correlated with better radiological results in adults. Our findings showed that the pooled adverse event (AE) rate was 96% (95% CI, 69-100%) in pediatrics and 83% (95% CI, 42-97%) among adults; however, there was no meaningful difference (P = 0.30).

CONCLUSION:

Co-administration of dabrafenib and trametinib is accompanied by promising results among pediatrics and adults diagnosed with glioma. However, the comparison results should be interpreted meticulously due to limitations that may affect the generalizability of the findings.

News (Medical) associated with Dabrafenib Mesylate

17 Jun 2025

·endpoints.news

Immuneering says MEK pill beats standard of care in first-line pancreatic cancer

Immuneering’s oral MEK inhibitor allowed 94% of pancreatic cancer patients in a Phase 2a trial to survive six months when used first-line in combination with chemotherapy, the company said Tuesday. Atebimetinib (formerly IMM-1-104) is in an ongoing Phase 2a solid tumors study with five cohorts. Tuesday’s data came from 34 pancreatic cancer patients given modified gemcitabine and nab-paclitaxel (mGnP), with atebimetinib dosed at 320 mg once daily. For context, Immuneering pointed out that mGnP is one of the standards of care in first-line pancreatic cancer, and in a 2013 trial, it resulted in a six-month OS rate of around 67% . The chemotherapy doublet was not tested in a separate arm in the Phase 2a trial, so the comparison is not direct. Median overall survival had not been reached in the patients given atebimetinib and mGnP by the data cutoff date of May 26. The six-month progression-free survival rate in these patients was 72%, the biotech said. The benchmark here with mGnP is 44%. Median PFS was not reached at the data cutoff. The overall response rate and disease control rate were 39% and 81%, respectively, in 36 response-evaluable patients at both the 240 and 320 mg doses of atebimetinib plus mGnP. The Phase 2a is also assessing atebimetinib as a monotherapy, and other arms are investigating it with the FOLFIRINOX chemo regimen, Novartis’ Tafinlar, and Merck’s Keytruda. The trial is also enrolling subjects with tumors, including lung cancer and melanoma. On safety, Immuneering said that no grade 3 or worse adverse events occurred “in a majority of the adverse event categories commonly observed with standard of care chemotherapy in first line pancreatic cancer,” but did not provide further details. More data from the trial are expected in the fourth quarter of this year. The company intends to boost enrollment in the mGnP arm to around 50 patients. It intends to start a pivotal trial of the drug next year and will look at the mGnP combination, again in the first-line setting. Mizuho analysts wrote in a Monday note that they forecast peak risk-unadjusted sales for atebimetinib of around $3.5 billion “across multiple indications, but with pancreatic cancer representing the lion’s share.”

Clinical ResultPhase 2ADC

24 Mar 2025

·www.businesswire.com

Vicero Welcomes Renowned Cancer Immunotherapy Experts to its Scientific Advisory Board

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vicero, Inc., a preclinical-stage biopharmaceutical company developing next-generation VINCOBODIES for immune-mediated diseases, today announced the appointment of two distinguished oncologists and immunotherapy experts, Sumit Subudhi, M.D., Ph.D., and Antoni Ribas, M.D., Ph.D., to its Scientific Advisory Board. "We are honored to welcome Dr. Subudhi and Dr. Ribas to our Scientific Advisory Board," said Vikram Kansra, PhD, Founder and Chief Executive Officer of Vicero. "Their pioneering work in cancer immunotherapy and extensive clinical development experience will be invaluable as we advance our VINCOBODY platform, which creates multi-specific molecules designed to overcome the limitations of conventional antibody combinations. Their strategic guidance comes at a pivotal moment in our development as we aim to optimize our bispecific PD-1/CTLA-4 program to deliver potent anti-tumor effects while minimizing immune-related adverse events, ultimately benefiting cancer patients who need better therapeutic options.” Dr. Subudhi is an Associate Professor in the Department of Genitourinary Medical Oncology at The University of Texas MD Anderson Cancer Center. A trained medical oncologist and immunologist, he serves as the principal investigator of multiple biomarker-rich clinical trials evaluating immune checkpoint therapies, bispecific T cell engagers and vaccines. Dr. Subudhi’s translational research focuses on investigating the immunological mechanisms mediating anti-tumor responses and therapy-related toxicities with the ultimate goal of maximizing efficacy and minimizing toxicities for patients with advanced prostate cancer. He also served as lead principal investigator for Prostate Researching Translational Endpoints Correlated to Response (PORTER) clinical trials to inform use of novel combinations, which were sponsored by Parker Institute of Cancer Immunotherapy (PICI) and Cancer Research Institute (CRI). His work has led to the identification of mechanisms associated with resistance to immunotherapies and candidate biomarkers of responses to these approaches. "I am excited to join Vicero's Scientific Advisory Board and provide guidance to the esteemed team in the development of innovative approaches in cancer immunotherapy," said Dr. Subudhi. "The company's novel platform has the potential to address significant unmet needs, particularly in difficult-to-treat cancers where current immunotherapies have shown limited efficacy." Dr. Ribas is professor of medicine, surgery and molecular and medical pharmacology at the University of California Los Angeles (UCLA), director of the Tumor Immunology Program at the Jonsson Comprehensive Cancer Center and director of the Parker Institute for Cancer Immunotherapy Center at UCLA. He has been instrumental in the clinical development of several FDA-approved agents, including the first anti-PD-1 pembrolizumab (Keytruda), the anti-CTLA-4 tremelimumab (Imjudo) and multiple BRAF and MEK inhibitor combinations. Dr. Ribas is a past president of the American Association for Cancer Research (AACR) and an elected member of the US National Academy of Medicine. Recent work includes laboratory and clinical translational research in adoptive cell transfer therapy with T-cell receptor engineered lymphocytes; examining the antitumor activity of PD-1-blocking antibodies; testing novel targeted therapies blocking oncogenic events in melanoma; and studying primary and acquired resistance to melanoma therapies. Dr. Ribas has been instrumental in the clinical development of several agents approved by the FDA, including the first anti-PD-1 pembrolizumab (Keytruda), the anti-CTLA-4 tremelimumab (Imjudo), two combinations of BRAF and MEK inhibitors vemurafenib (Zelboraf) and cobimetinib (Cotellic), dabrafenib (Tafinlar) and trametinib (Mekinist). He is the recipient of the AACR Richard and Hinda Rosenthal Award, the William B. Coley Award from Cancer Research Institute (CRI), the AACR-CRI Lloyd J. Old Award in Cancer Immunology, two NCI Outstanding Investigator Awards and several other awards, and is a Doctor Honoris Causa from the University of Buenos Aires and the Free University of Brussels. “Vicero's approach to targeting the tumor microenvironment represents a tremendous opportunity to potentially enhance the efficacy of cancer immunotherapies and overcome the longstanding challenges of balancing efficay with safety," said Dr. Ribas. "I’m excited to work with this strong team of highly accomplished drug developers who have already brought many innovative therapies to patients in need and have a genuine commitment to transforming patient care. Vicero’s platform and lead asset hold high promise to overcome limitations in immunotherapy and I’m looking forward to helping finalize the clinical strategy and advance this program into clinic.” About Vicero Vicero is a preclinical biopharmaceutical company pioneering the development of next-generation multivalent VHH VINCOBODIES to conquer unmet medical needs in cancer and immunology. The VINCOBODY product engine is proprietary VHH modular technology that enables Vicero to build best in class IO and ADC therapeutics with the potential to address unmet need in the immuno-oncology solid tumor market. Our team of experienced scientists and drug developers has delivered more than 20 life extending therapies to patients in need. For more information, please visit us at www.vicerobio.com or our LinkedIn page.

Executive ChangeImmunotherapy

20 Mar 2025

·www.prnewswire.com

Caris Life Sciences Publishes Study Featuring the Largest Real-World Cohort of Tissue-Agnostic Indications Revealing Over 20 Percent of Patients Are Eligible for "Pan-Cancer" Therapies

A 295,000+ patient study revealed variable efficacy among cancers for patients treated with tissue-agnostic drugs and uncovered the potential for expanding approvals to other drugs of the same class IRVING, Texas, March 20, 2025 /PRNewswire/ -- Caris Life Sciences® (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, today announced the publication of "Real-world evidence provides clinical insights into tissue-agnostic therapeutic approvals" in Nature Communications. Utilizing the largest real-world clinical and genomic dataset of tissue-agnostic indications reported to date across more than 295,000 patients, the study provides a comprehensive evaluation of real-world outcomes for patients eligible for these powerful "pan-cancer" therapies, such as pembrolizumab and larotrectinib. These drugs are categorized as tumor-agnostic therapies, targeting specific genetic or molecular features of tumors rather than their anatomical location or histology. The study focused on the use and clinical benefits of tissue-agnostic therapies, which target specific molecular biomarkers across numerous cancer types. Key findings include: More than 20 percent of patients are candidates for a tissue-agnostic drug. Approximately five percent of patients who lacked any tumor-specific indication were found to carry a tissue-agnostic indication and became eligible for tissue-agnostic drug treatment. Tissue-agnostic therapy uptake was poor for rare indications, illustrating the need for enhanced clinical education. Current tissue-agnostic indications could potentially be expanded, as evidenced by clinical benefits in tumor types and drugs of the same class that were not investigated in the original clinical trials. "By harnessing the power of Caris' large clinico-genomic dataset, we have shown that tissue-agnostic drugs produce different outcomes in different tissues," said George W. Sledge, Jr., MD, EVP and Chief Medical Officer of Caris and study author. "We additionally found evidence of clinical benefit beyond approved indications, illustrating the enormous potential of real-world data to inform the clinical use of tissue-agnostic drug approvals, potentially improving patient outcomes." "Caris has generated one of the most extensive clinico-genomic datasets in oncology through years of comprehensive molecular profiling," said Caris President and study author David Spetzler, MS, PhD, MBA. "Our advanced analyses of real-world data now enable us to uncover findings of clinical value for large patient populations. One in five patients in our study were eligible for a tissue-agnostic drug, which demonstrates the widespread impact of our findings." Detailed Scientific Information This study used a real-world database of 295,316 molecularly profiled tumor samples with associated clinical outcomes data across 57 tumor types to investigate the utility and uptake of six tissue-agnostic therapies (pembrolizumab, larotrectinib, entrectinib, dostarlimab, dabrafenib and selpercatinib). At least one current FDA-approved tissue-agnostic indication (TMB-High, MSI-High/dMMR, BRAFV600E mutations, and NTRK and RET fusions) was detected in 21.5% of patients, including 5.4% lacking any tumor-specific indication. In patients with rare NTRK fusions, there was poor clinical uptake of the clinically successful targeted therapies larotrectinib and entrectinib, underlining the need for oncologist education on rare indications. Strikingly, significant differences in pembrolizumab-associated outcomes were observed across tumor types for the most common indications (TMB-High and MSI-High/dMMR), demonstrating that the effects of these therapies are not tissue-agnostic. Clinical benefits were also observed in tumor types and drugs of the same class (such as nivolumab) that were not investigated in pivotal clinical trials. This suggests the possible expansion of therapeutic avenues for a given tissue-agnostic indication. These findings demonstrate the power of Caris' extensive real-world dataset for generating valuable clinical insights to inform the clinical implementations of tissue-agnostic drug approvals and improve outcomes for patients with cancer. Designed to capture and analyze molecular information from tissue and blood in a comprehensive manner, the proprietary Caris Platform is a powerful set of precision medicine solutions, providing Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS) as standard practice. Caris sequences at sector-leading depth of coverage, which directly correlates to increased accuracy and detection of low-frequency biomarkers of relevance. Caris also evaluates protein biomarkers through an extensive menu of immunohistochemical (IHC) tests analyzed in a tumor-type specific manner, which in combination with WES and WTS, provides a comprehensive view of a patient's disease across DNA, RNA and proteins. The Caris approach reveals an individualized molecular blueprint of a patient's disease, providing actionable, personalized treatment pathways and driving superior clinical outcomes for patients. About Caris Life Sciences Caris Life Sciences® (Caris) is a leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced AI and machine learning algorithms, Caris has created the large-scale, multimodal database and computing capability needed to analyze and further unravel the molecular complexity of disease. This convergence of sequencing power, big data and AI technologies provides a differentiated platform to deliver the next generation of precision medicine tools for early detection, diagnosis, monitoring, therapy selection and drug development. Caris was founded with a vision to realize the potential of precision medicine in order to improve the human condition. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Cambridge (MA), Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S. and other international markets. To learn more, please visit CarisLifeSciences.com. Caris Life Sciences Media: Corporate Communications [email protected] 214.294.5606 SOURCE Caris Life Sciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with Dabrafenib Mesylate

External Link

KEGG	Wiki	ATC	Drug Bank
D10104	Dabrafenib Mesylate	L01XE23	DB08912

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
BRAF Fusion Glioma	Japan	Novartis Pharma AG	24 Sep 2024
BRAF mutation positive hairy cell leukemia	Japan	Novartis Pharma AG	24 Nov 2023
BRAF mutation Solid Tumors	Japan	Novartis Pharma AG	24 Nov 2023
High grade glioma	European Union	Novartis Europharm Ltd.	15 Nov 2023
High grade glioma	Iceland	Novartis Europharm Ltd.	15 Nov 2023
High grade glioma	Liechtenstein	Novartis Europharm Ltd.	15 Nov 2023
High grade glioma	Norway	Novartis Europharm Ltd.	15 Nov 2023
Low grade glioma	European Union	Novartis Europharm Ltd.	15 Nov 2023
Low grade glioma	Iceland	Novartis Europharm Ltd.	15 Nov 2023
Low grade glioma	Liechtenstein	Novartis Europharm Ltd.	15 Nov 2023
Low grade glioma	Norway	Novartis Europharm Ltd.	15 Nov 2023
BRAF V600E mutation-positive low grade glioma	United States	Novartis Pharmaceuticals Corp.	16 Mar 2023
BRAF V600E Mutation-Positive Anaplastic Thyroid Cancer	United States	Novartis Pharmaceuticals Corp.	04 May 2018
BRAF Mutation Non-small Cell Lung Cancer	Japan	Novartis Pharma AG	28 Mar 2016
BRAF mutation positive Melanoma	Japan	Novartis Pharma AG	28 Mar 2016
BRAF V600E mutant Non-small Cell Lung Cancer	South Korea	Novartis Korea Ltd.	25 Sep 2014
BRAF V600E Mutation-Positive Solid Tumors	South Korea	Novartis Korea Ltd.	25 Sep 2014
BRAF V600K Mutation-Positive Melanoma	United States	Novartis Pharmaceuticals Corp.	09 Jan 2014
Melanoma	Australia	Novartis AG	27 Aug 2013
BRAF V600 mutation-positive Melanoma	European Union	Novartis Europharm Ltd.	26 Aug 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Differentiated Thyroid Gland Carcinoma	Phase 3	United States	Novartis Pharmaceuticals Corp.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	China	Beijing Novartis Pharma Co. Ltd.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	China	Novartis Pharmaceuticals Corp.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	Argentina	Novartis Pharmaceuticals Corp.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	Argentina	Beijing Novartis Pharma Co. Ltd.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	Brazil	Novartis Pharmaceuticals Corp.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	Brazil	Beijing Novartis Pharma Co. Ltd.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	Canada	Novartis Pharmaceuticals Corp.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	Canada	Beijing Novartis Pharma Co. Ltd.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	India	Novartis Pharmaceuticals Corp.	15 Nov 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2025	Not Applicable	BRAF V600 mutation-positive Melanoma Neoadjuvant BRAF V600 mutation	-	Dabrafenib plus Trametinib	davxxvrsyx(qgcrtumgwn) = vsowtxgtdw utdizmpimp (slrowwasak, 74.5 - 92) View more	Positive	30 May 2025
				Dabrafenib monotherapy	davxxvrsyx(qgcrtumgwn) = avkgjpyntg utdizmpimp (slrowwasak, 55.2 - 69.7)
NCT05988697 (ASCO2025)	Phase 2	BRAF V600 Mutation-Positive Non-small Cell Lung Cancer	-	Dabrafenib 150 mg BID + Trametinib 2 mg QD + Aspirin 100 mg QD	ozgukfhapg(iyioogbglf) = nqrejavqtz ymzbyawohd (scqgryrunq )	Positive	30 May 2025
ASCO2025	Not Applicable	-	109	dabrafenib (Patients with Pyrexia Syndrome)	ltanfcyzba(bpdvelbodg) = Pyrexia syndrome is the most common adverse event in patients treated with dabrafenib and trametinib. qwzlrelifd (ugltrelqge ) View more	Positive	30 May 2025
				dabrafenib (Patients with Severe/Complicated Pyrexia Syndrome)
ASCO2025	Not Applicable	Locally Advanced Melanoma Adjuvant	-	Dabrafenib and Trametinib (D+T)	ffdvjyaqpe(vjbjdqkrht) = D+T was associated with a higher rate of treatment discontinuation due to adverse events (AEs), with a relative risk (RR) of 1.57 (95% CI 1.30-1.91, p < 0.01; I² = 0%), corresponding to a risk difference of 8% (95% CI 5%-12%, p < 0.01; I² = 0%) bhclomkmux (dgpmfockou ) View more	Positive	30 May 2025
				Anti-PD(L)1 therapies (Pembrolizumab, Nivolumab, Toripalimab)
NCT04238624 (Pilot study evaluating the addition of cemiplimab in BRAF-mutant anaplastic thyroid cancer after progression on dabrafenib and trametinib, ASCO2025)	Phase 2	BRAF mutated anaplastic thyroid cancer BRAF mutation	12	Dabrafenib and Trametinib (DT) + Cemiplimab (Cemi)	zsroxzpnbn(vlwhdedtow) = iauwogctrr stfzrvnfwm (vrflflstxr )	Positive	30 May 2025
ASCO2025	Not Applicable	BRAF mutated anaplastic thyroid cancer BRAF V600 mutations	82	Dabrafenib and Trametinib	krwnitlinc(ggguxlsxzv) = zbuskictpg mxefcvglnt (eqatpohwyf )	Positive	30 May 2025
				Dabrafenib (Surgery only)	krwnitlinc(ggguxlsxzv) = wbnppnhqvv mxefcvglnt (eqatpohwyf )
ASCO2025	Not Applicable	Melanoma Adjuvant resected stage III-IV	70	Adjuvant anti-PD1 therapy	tlsouwiuvd(yunglewdoz) = mubwrrekkt xuvvrgvldg (mfghqasbaf )	-	30 May 2025
				Dabrafenib-trametinib therapy	tlsouwiuvd(yunglewdoz) = hzjwoqoqmm xuvvrgvldg (mfghqasbaf )
NCI-MATCH (AACR2025)	Not Applicable	Lung Cancer \| Melanoma \| Colorectal Cancer	19	Dabrafenib and Trametinib	llriabfwyf(ifcbwbcdif) = iaowtoujvv wjgoqhlflq (lfdvfxkucq ) View more	Positive	29 Apr 2025
ESMO_TAT2025	Not Applicable	Biliary Tract Neoplasms First line molecular alterations	666	Targeted Therapy	zinxqtkahu(bnaukicykw) = fenbyiimyi ssxsenxual (eqiikhwgxn, 13.9 - 29.1) View more	Positive	03 Mar 2025
				Chemotherapy	zinxqtkahu(bnaukicykw) = jtlnltqfcg ssxsenxual (eqiikhwgxn )
NCT03668431 (NEWS) Manual	Phase 2	BRAF V600E mutant Colorectal Cancer BRAF V600E	37	Dabrafenib + Trametinib + Spartalizumab	bgufooqyee(tjdocioxtm) = zfjedoiqzn uyhjkigmrw (qchwjzlwpy ) View more	Positive	01 Mar 2025

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