Delving into the Latest Updates on Dabrafenib Mesylate with Synapse

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

Login to view timeline

Structure/Sequence

Molecular FormulaC24H24F3N5O5S3

InChIKeyYKGMKSIHIVVYKY-UHFFFAOYSA-N

CAS Registry1195768-06-9

This phase II trial studies how well de-escalating the drugs dabrafenib and trametinib works in treating patients with low-grade gliomas that have a BRAF V600 gene mutation. Dabrafenib and trametinib are in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals tumor cells to multiply. This helps stop the spread of tumor cells. This trial may help doctors determine the best dosing strategy for patients who have received dabrafenib and trametinib for 12-24 months: Either stopping dabrafenib and trametinib completely or slowly reducing the dose for an additional 6 months.

Start Date07 Nov 2025

Sponsor / Collaborator

The University of California, San Francisco

[+1]

NCT07092670

/ RecruitingNot ApplicableIIT

MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse. A Prospective Multicenter Observational Study

Melanoma survivorship in reproductive-age women is increasing due to the advent of effective therapies in the curative setting. However, while the impact on fertility and ovarian function of chemotherapy agents is well known, there is still a lack of consistent data regarding novel the Mitogen-activated protein kinase (MAP) kinase pathway inhibitors and immune-checkpoint inhibitors (ICIs) used in melanoma.
A recent study showed that a single course of anti-PD-1 (PD, Programmed cell death protein 1) or anti-CTLA-4 (Cytotoxic T-Lymphocyte Antigen 4) reduced both the number and quality of oocytes in mice through an immune-mediated mechanism. In particular, primordial follicle damage cannot be restored, leading to relevant clinical implications.
The study aims to help to determine the impact of MAP kinase pathway inhibitors and ICIs on reproductive outcomes, and whether clinicians should discuss (and in what terms) fertility preservation techniques in reproductive-age women receiving ICIs and MAP kinase pathway inhibitors in the adjuvant setting.

Start Date04 Aug 2025

Sponsor / Collaborator

Intergruppo Melanoma Italiano

100 Clinical Results associated with Dabrafenib Mesylate

Login to view more data

100 Translational Medicine associated with Dabrafenib Mesylate

Login to view more data

100 Patents (Medical) associated with Dabrafenib Mesylate

Login to view more data

2,412

Literatures (Medical) associated with Dabrafenib Mesylate

01 Dec 2026·JOURNAL OF COMPUTER-AIDED MOLECULAR DESIGN

Computational study on QSAR modeling, molecular docking, and ADMET profiling of pyrazole-modified catalpol derivatives as prospective dual inhibitors of VEGFR-2/BRAF V600E

Article

Author: Mandal, Manab ; Pal, Sumanta ; Ghosh, Narendra Nath ; Singh, Vivek Dutta ; Pati, Soumen Kumar

Pancreatic and Esophageal cancers are highly aggressive with high mortality and limited treatment, causing over 466,000 and 544,100 deaths worldwide in 2020 respectively. This highlights the urgent need for safer,and effective anticancer agents. Catalpol, a natural iridoid glycoside, shows anticancer potential, but due to its poor drug-like properties it requires structural modification. This study investigates pyrazole-modified catalpol derivatives as dual inhibitors for these cancers using Quantitative Structure Activity Relationship (QSAR) modelling, molecular docking, and pharmacokinetic studies. We analyzed fourteen pyrazole-modified catalpol derivatives with reported IC50values against four cancer cell lines(BxPC-3, PANC-1, Eca109, and EC9706). The molecules were optimized using DensityFunctional Theory (DFT), and 2D molecular descriptors were calculated using PaDEL. QSAR models were developed by utilizing a Genetic Function Algorithm (GFA) and Multiple Linear Regression (MLR) and validated using statistical metrics such as R², Q², R²adj, and R²pred. Docking studies targeted VEGFR-2 and BRAF V600E kinases using AutoDockVina, while ADMET and drug-likeness properties were predicted using SwissADME and pkCSM tools. The external validation R²pred values for BxPC-3, PANC-1, Eca109, and EC9706 cell lines were 0.9412, 0.9535, 0.9981, and 0.9935, respectively. Among the derivatives, compound 3k showed the highest binding affinity for VEGFR-2 (- 8.18 kcal/mol) and BRAF (- 8.64 kcal/mol), surpassing the control drugs etoposide (- 8.00 kcal/mol) and dabrafenib (- 8.15 kcal/mol) respectively. ADMET analysis confirmed good intestinal absorption, limited blood-brain barrier penetration, non-toxicity, acceptable total clearance, and compliance with Lipinski's rule. Overall, the study suggests that pyrazole-modified catalpol derivatives, especially compound 3k, are promising multi-target inhibitors for pancreatic and esophageal cancers, justify further in-vitro and in-vivo studies.

01 Mar 2026·CLINICAL ENDOCRINOLOGY

Surgical Outcomes Following Neoadjuvant‐Targeted Therapy for Advanced Differentiated Thyroid Cancer—Real‐World Data

Article

Author: Horowitz, Gilad ; Furman, Liyona Kampel ; Muhanna, Nidal ; Alon, Eran ; Mansour, Jobran ; Joshua, Ben‐Zion ; Finkel, Inbar ; Shilo, Shahaf ; Avior, Galit ; Gutfeld, Orit ; Izkhakov, Elena ; Remer, Eric ; Dorman, Alexandra ; Khafif, Avi ; Warshavsky, Anton ; Shendler, Genady

ABSTRACT:

Background:

Differentiated thyroid carcinoma (DTC) is typically managed surgically with favourable outcomes. However, surgery may have dire consequences when the tumour invades critical structures. Neoadjuvant therapy with tyrosine kinase inhibitors (TKIs) has emerged as a potential strategy to improve resectability and reduce morbidity in advanced DTC. We evaluated the efficacy and safety of neoadjuvant TKI therapy in patients with advanced or unresectable DTC.

Methods:

A retrospective study was conducted on patients with advanced DTC treated with neoadjuvant TKIs (lenvatinib or dabrafenib/trametinib) followed by curative intent surgery between 2023 and 2025. Data on disease extent, genetic alterations, treatment regimens, and adverse effects were collected. Radiologic response was assessed by CT or PET‐CT according to the RECIST 1.1 criteria. Surgical outcomes were evaluated by the degree of morbidity and by tumour involvement in the surgical margins.

Results:

Nine patients were included, seven treated with lenvatinib, two treated with dabrafenib/trametinib on the basis of molecular alterations. The median duration of TKI therapy was 5 months, and no disease progression was observed throughout. Radiological assessment revealed a median reduction in tumour burden of 23.53%, contributing to improved tumour resectability. All patients underwent surgical resection with preservation of critical structures. Elevated TSH levels during neoadjuvant therapy was correlated with a positive treatment response ( p = 0.028).

Conclusions:

Neoadjuvant TKIs may improve the surgical outcomes of patients with advanced DTC. Decision‐guided radiological and blood‐based surrogate biomarkers, such as TSH, can assist in evaluating treatment response and guide decisions regarding treatment duration and extent of surgical resection.

01 Feb 2026·EUROPEAN JOURNAL OF CANCER

Targeting driver mutations in lung cancer with interstitial pneumonia: A nationwide study in Japan

Article

Author: Tanino, Yoshinori ; Waseda, Yuko ; Inomata, Minehiko ; Amimoto, Hisanori ; Ogura, Takashi ; Yamauchi, Hiroyoshi ; Ichikado, Kazuya ; Ikeda, Satoshi ; Kinoshita, Yoshiaki ; Hashimoto, Naozumi ; Ozasa, Hiroaki ; Nakamura, Yutaro ; Hashimoto, Seishu ; Murakami, Koji ; Itoh, Taku ; Karayama, Masato ; Kato, Motoyasu ; Isshiki, Takuma ; Sakamoto, Noriho ; Nishioka, Yasuhiko ; Kishi, Kazuma ; Yanagihara, Toyoshi ; Okishio, Kyoichi ; Fukuizumi, Aya ; Nishikiori, Hirotaka ; Sato, Yuki ; Honda, Takayuki ; Kishaba, Tomoo ; Ishida, Yuriko ; Koyama, Junji ; Tsurumaki, Nozomu ; Tamura, Kentaro ; Yamaguchi, Kakuhiro ; Miyamoto, Atsushi ; Yamane, Mayuka ; Takata, Saori ; Kikuchi, Ryota ; Misumi, Toshihiro ; Yatera, Kazuhiro ; Matsumoto, Masaru

INTRODUCTION:

Non-small cell lung cancer (NSCLC) patients with comorbid interstitial pneumonia (IP) are at high risk for drug-induced pneumonitis, and previous reports suggest a lower frequency of common driver mutations such as EGFR. This may discourage genetic testing, potentially overlooking prevalent, targetable mutations like KRAS, BRAF, and MET. This study aimed to elucidate the real-world status of genetic testing, the frequency of oncogenic drivers, and the safety and efficacy of targeted therapies in patients with NSCLC and comorbid IP.

METHODS:

This multicenter, retrospective study analyzed 1256 patients with advanced or recurrent NSCLC and comorbid chronic fibrosing IP from 37 Japanese institutions (Registry number: UMIN000055609).

RESULTS:

The rate of any genetic testing was 59.2 % (95 % confidence interval [CI], 56.5-62.0), with multigene testing performed in only 41.0 % (95 %CI, 38.3-43.8). Among patients with NSCLC undergoing multigene testing (N = 515), the most frequent mutations were KRAS (4.7 %; G12C, 1.9 %), followed by EGFR (2.9 %), BRAF V600E (1.6 %), and MET exon 14 skipping (1.6 %). The incidence of drug-induced pneumonitis was 0 % (0/6) for sotorasib, 50 % (4/8) for osimertinib, 33 % (1/3) for alectinib, and 25 % (1/4) for both dabrafenib plus trametinib and tepotinib. Patients with actionable oncogenic drivers receiving targeted therapy had the longest overall survival, followed by those not receiving it, and then driver-negative/unknown patients (median: 39.2, 24.0, and 13.8 months, respectively).

CONCLUSIONS:

Multigene testing is underutilized in this population. While many targeted therapies carry a high risk of pneumonitis, sotorasib appeared relatively safe. Despite the risks, identifying and treating actionable oncogenic drivers may improve survival.

89

News (Medical) associated with Dabrafenib Mesylate

02 Jan 2026

·www.einpresswire.com

July - September 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

ADZYNMA (ADAMTS13, recombinant-krhn) Neutralizing antibodies with fatal outcome FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on November 21, 2025: FDA Investigating Death Due to Neutralizing Antibodies to ADAMTS13 following Adzynma Treatment of Congenital Thrombotic Thrombocytopenic Purpura Asceniv (immune globulin intravenous, human-slra) Increased hypersensitivity reactions in patients receiving certain product lot FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on October 28, 2025: Immune Globulin Intravenous (IGIV) and/or Immune Globulin Subcutaneous (IGSC) Lots with Increased Reports of Allergic/Hypersensitivity Reactions Benlysta (belimumab) injection Severe cutaneous adverse reactions FDA is evaluating the need for regulatory action. Braftovi (encorafenib) capsules Tafinlar (dabrafenib) capsules; tablets Zelboraf (vemurafenib) tablet Sarcoidosis FDA is evaluating the need for regulatory action. Cabometyx (cabozantinib) tablets Cometriq (cabozantinib) capsules Lenvima (lenvatinib) capsules Thrombotic microangiopathy FDA is evaluating the need for regulatory action. Cotellic (cobimetinib) tablets Mekinist (trametinib) tablets; oral solution Mektovi (binimetinib) tablets Sarcoidosis FDA is evaluating the need for regulatory action. ELEVIDYS (delandistrogene moxeparvovec-rokl) Mesenteric vein thrombosis following product-related acute liver injury The "Warnings and Precautions" and "Adverse Reactions - Postmarketing Experience" sections of the labeling for Elevidys were updated in November 2025 to include life-threatening mesenteric vein thrombosis. FDA Safety Communication was issued on November 14, 2025: FDA Takes Action on New Boxed Warning for Acute Serious Liver Injury and Acute Liver Failure Following Treatment with Elevidys and Revised Indication that is Limited to Ambulatory Duchenne Muscular Dystrophy Patients Firmagon (degarelix for injection) Myfembree (relugolix, estradiol, and norethindrone acetate) tablets Orgovyx (relugolix) tablets Drug interaction FDA is evaluating the need for regulatory action. Ifex (ifosfamide) injection Pregnancy, puerperium and perinatal conditions FDA is evaluating the need for regulatory action. Ogsiveo (nirogacestat) tablets Visual impairment FDA is evaluating the need for regulatory action. Orgovyx (relugolix) tablets Hypertension FDA is evaluating the need for regulatory action. Rezzayo (rezafungin for injection) Hypersensitivity The "Warnings and Precautions", "Adverse Reactions" and "Patient Counseling Information" sections of the labeling were updated in December 2025 to include information about hypersensitivity reactions, including anaphylaxis. Rezzayo labeling Septocaine (articaine hydrochloride and epinephrine injection) Mepivacaine hydrochloride injection (a particular generic product) Wrong drug administered FDA is evaluating the need for regulatory action. Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalBiosimilar

30 Sep 2025

·www.einpresswire.com

April - June 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Acetaminophen-containing products Anaphylactic reaction FDA is evaluating the need for regulatory action. Aptryxol (desvenlafaxine) DaTscan (ioflupane I 123 injection) Desvenlafaxine extended-release tablets Effexor XR (venlafaxine extended-release) capsules Pristiq (desvenlafaxine) extended-release tablets Venlafaxine (venlafaxine hydrochloride) extended-release tablets False positive radioisotope investigation test result potentially secondary to a drug interaction with venlafaxine FDA is evaluating the need for regulatory action. Barium sulfate-containing products Entero Vu 24% (barium sulfate) oral suspension E-Z-Disk (barium sulfate) tablets Liquid E-Z-Paque (barium sulfate) oral suspension Readi-Cat 2 (barium sulfate) oral suspension Readi-Cat 2 Smoothie (barium sulfate) oral suspension Taglitol V (barium sulfate) oral suspension Varibar Honey (barium sulfate) oral suspension Varibar Nectar (barium sulfate) oral suspension Varibar Pudding (barium sulfate) oral paste Varibar Thin Honey (barium sulfate) oral suspension Varibar Thin Liquid (barium sulfate) oral suspension Anaphylactic reaction FDA is evaluating the need for regulatory action. Blincyto (blinatumomab) for injection Columvi (glofitamab-gxbm) injection Elrexfio (elranatamab-bcmm) injection Epkinly (epcoritamab-bysp) injection Imdelltra (tarlatamab-dlle) for injection Kimmtrak (tebentafusp-tebn) injection Lunsumio (mosunetuzumab-axgb) injection Talvey (talquetamab-tgvs) injection Tecvayli (teclistamab-cqyv) injection Progressive multifocal leukoencephalopathy FDA is evaluating the need for regulatory action. BRAF kinase inhibitors Braftovi (encorafenib) capsules Ojemda (tovorafenib) for oral suspension; tablets Tafinlar (dabrafenib) capsules; tablets Zelboraf (vemurafenib) tablets Gingival hypertrophy FDA is evaluating the need for regulatory action. Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Acute hepatic failure The "Warnings and Precautions" section of the labeling was updated in August 2025 to include information about liver injury. Example: Briumvi labeling Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Ocrevus (ocrelizumab) injection Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) injection Central nervous system infection FDA is evaluating the need for regulatory action. Crexont (carbidopa and levodopa) extended-release capsules Dhivy (carbidopa and levodopa) tablets Duopa (carbidopa and levodopa) enteral suspension Rytary (carbidopa and levodopa) extended-release capsules Sinemet (carbidopa and levodopa) tablets Sinemet CR (carbidopa and levodopa) sustained-release tablets Stalevo (carbidopa, levodopa and entacapone) tablets Vyalev (foscarbidopa and foslevodopa) injection Seizure FDA is evaluating the need for regulatory action. Crysvita (burosumab-twza) injection Hypercalcemia The "Dosage and Administration", "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in August 2025 to include information about hypercalcemia. Crysvita labeling Dexmedetomidine-containing products Dexmedetomidine injection Precedex (dexmedetomidine hydrochloride) injection Igalmi (dexmedetomidine) sublingual film Diabetes insipidus FDA is evaluating the need for regulatory action. Dupixent (dupilumab) injection Ocular infections, irritations, and inflammation FDA is evaluating the need for regulatory action. Eprontia (topiramate) oral solution Qudexy XR (topiramate) extended-release capsules Qsymia (phentermine and topiramate) extended-release capsules Topamax (topiramate) tablets Topamax Sprinkle (topiramate) capsules Trokendi XR (topiramate) extended-release capsules Hypersensitivity FDA is evaluating the need for regulatory action. Gavreto (pralsetinib) capsules Chylothorax FDA is evaluating the need for regulatory action. Glucagon-like peptide-1 (GLP-1) receptor agonists Adlyxin (lixisenatide) injection Bydureon (exenatide) for extended-release injectable suspension Bydureon BCise (exenatide extended-release) injectable suspension Byetta (exenatide) injection Mounjaro (tirzepatide) injection Ozempic (semaglutide) injection Rybelsus (semaglutide) tablets Saxenda (liraglutide) injection Soliqua 100/33 (insulin glargine and lixisenatide) injection Trulicity (dulaglutide) injection Victoza (liraglutide) injection Wegovy (semaglutide) injection Xultophy 100/3.6 (insulin degludec and liraglutide) injection Zepbound (tirzepatide) injection Intestinal obstruction and fecal impaction FDA is evaluating the need for regulatory action. Imbruvica (ibrutinib) capsules; tablets; oral suspension Nail and nail bed conditions (excluding infections and infestations) FDA is evaluating the need for regulatory action. MEK inhibitors Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets) Cotellic (cobimetinib) tablets Mekinist (trametinib) tablets; oral solution Mektovi (binimetinib) tablets Koselugo (selumetinib) capsules Gingival hypertrophy FDA is evaluating the need for regulatory action. Neffy (epinephrine nasal spray) Product storage error FDA is evaluating the need for regulatory action. Nurtec ODT (rimegepant) orally disintegrating tablets Zavzpret (zavegepant) nasal spray Anaphylactic reaction The "Contraindications" and "Warnings and Precautions" sections of the labeling were updated in August 2025 to include information about hypersensitivity reactions, including anaphylaxis. Example: Nurtec ODT labeling Rozlytrek (entrectinib) capsules; oral pellets Brugada syndrome FDA is evaluating the need for regulatory action. Sodium-glucose cotransporter-2 (SGLT2) inhibitors Fournier's gangrene FDA is evaluating the need for regulatory action. Teriparatide injection (a particular generic product) Device malfunction FDA is evaluating the need for regulatory action. Vizamyl (flutemetamol F18 injection) Anaphylactic reaction The "Warnings and Precautions" section of the labeling was updated in June 2025 to include information about anaphylaxis and other serious hypersensitivity reactions. Vizamyl labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalBiosimilar

09 Sep 2025

·www.biospace.com

Novartis’ Busy BD Team Keeps 2025 Bolt-On Deal Promises

iStock, Diki Prayogo Executives at Novartis have not been shy about a desire to buy more companies, with cardiovascular a big focus. In total, the Swiss pharma has put $17.23 billion on the line in M&A and licensing deals this year. Novartis’ business development team sure has been busy. The Swiss pharma has notched three deals this month alone, including Tuesday’s $1.4 billion acquisition of cardiovascular biotech Tourmaline Bio. Earlier in the month, Novartis revealed two licensing deals, with Argo Biopharmaceutical and Arrowhead Pharma, worth a combined $7.56 billion in total potential deal value. In total this year, Novartis has put $17.23 billion on the line in M&A and licensing deals. The Tourmaline transaction will give Novartis access to an IL-6 targeting program for atherosclerotic cardiovascular disease (ASCVD) with the monocloncal antibody pacibekitug. BMO Capital Markets Tuesday morning said that Novartis offered a 37% premium in transaction value for the therapy, reflecting its best-in-class profile. The drug will compete with Novo Nordisk’s Phase III therapy ziltivekimab, which was acquired via Corvidia Therapeutics for $725 million in 2020. Novartis has been eager to fill up its pipeline, as the chronic heart failure medicine Entresto is expected to lose its patent exclusivity this year. Novartis will also contend with generic competition for Xolair this year and Jakafi next. Cosentyx and Tafinlar will also fall out of patent protection before the end of 2030. During a second-quarter earnings call in July, CFO Harry Kirsch said that Novartis is looking for “value-creating bolt-on deals.” The business development team—headed by Chief Strategy Growth Officer Ronny Gal—has signed 30 deals over the past two years, Kirsch noted. Kirsch specifically named the Regulus Therapeutics transaction from April as an example of the type of deal Novartis will be looking for going forward. That deal totaled $1.7 billion and bolstered Novartis’ oligonucleotide portfolio with the addition of autosomal dominant polycystic kidney disease (ADPKD) therapy farabursen. In late 2024, Novartis executives indicated a desire to have multiple assets in the clinic for arrhythmia by the end of 2025. Asked about this during the earnings call, CEO Vas Narasimhan said the goal remains top of mind. The company signed several licensing deals for preclinical assets to accomplish this—including one with Flagship Pioneering’s ProFound Therapeutics in June. “We see this as an area where we have unique expertise, probably one of the few companies still going after addressing cardiac arrhythmias,” Narasimhan told analysts on the call. “And obviously, if successful, market sizes here are quite large and the opportunity to use a medicine versus using the device-based cardio version is quite compelling for patients.”

AcquisitionLicense out/inOligonucleotide

100 Deals associated with Dabrafenib Mesylate

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
D10104	Dabrafenib Mesylate	L01XE23	DB08912

R&D Status

Approved

10 top approved records.

Login

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.

Login

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	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	Argentina	Beijing Novartis Pharma Co. Ltd.	15 Nov 2021
Differentiated Thyroid Gland Carcinoma	Phase 3	Argentina	Novartis Pharmaceuticals Corp.	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	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	India	Novartis Pharmaceuticals Corp.	15 Nov 2021

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04439292 (EAY131, Pubmed \| JCO Precis Oncol)	Phase 2	BRAF V600E Mutation-Positive Solid Tumors BRAF V600E	36	Dabrafenib 150 mg PO twice daily and Trametinib 2 mg PO once daily	pdgbkmptfg(vqslljchni) = pquamyvida jagbbzqvmc (fnbijgiepm, 22.9 - 51.2) View more	Positive	01 Jan 2026
ChiCTR2400091473 (ESMO_ASIA2025)	Phase 2	BRAF V600E	43	Dabrafenib combined with trametinib	kjmdjzcowl(arkprliiwc) = xjagayspvj dwybxfbiph (vuhnphxcej ) View more	Positive	05 Dec 2025
NCT04940052 (ESMO_ASIA2025)	Phase 3	BRAF V600E mutation-positive	76	Dabrafenib plus trametinib (D+T)	ekexqasipe(hlryhdprxi) = The incidence of grade ≥3 AEs was higher in the D+T (52.8%) than the PBO arm (21.7%). eufyeccesd (kxrohfdfzx ) View more	Positive	05 Dec 2025
				Placebo (PBO)
ESMO_ASIA2025	Not Applicable	BRAF mutated anaplastic thyroid cancer Neoadjuvant BRAF V600E	4	Dabrafenib + Trametinib (Neoadjuvant)	ntdhcnfwue(zkjcfvvwtr) = remained unreached wnvoxbamjd (bwuzglsngs )	Positive	05 Dec 2025
NCT04452877 (CTgov)	Phase 2	BRAF V600E mutant Non-small Cell Lung Cancer \| BRAF V600 Mutation-Positive Non-small Cell Lung Cancer	40	Dabrafenib+Trametinib	nuehpzwksq = dwjblvbcda nxfihlezpk (okoyvfufmc, jcoupsssmv - kixozlcswt) View more	-	04 Nov 2025
ESMO2025	Not Applicable	BRAF V600E	27	Dabrafenib plus trametinib	dlepzbbdxf(dxlfmwiibl) = kxqoqpgqnr kctbursyvk (guicmstxlz ) View more	Positive	17 Oct 2025
ESMO2025	Not Applicable	Glioblastoma BRAFV600E mutation \| NRTK-fusion	25	Dabrafenib-trametinib	secmgsfvjt(bamcbtoega) = ypznetfilk twryymorcl (vcoxrgvjxt ) View more	Positive	17 Oct 2025
				Larotrectinib	secmgsfvjt(bamcbtoega) = ivxclosdpi twryymorcl (vcoxrgvjxt ) View more
ESMO2025	Not Applicable	Melanoma First line \| Second line \| Third line	886	dabrafenib + trametinib (D+T)	pzlnohiner(szklpftghl) = yxisfqmmdn kfpepkuifn (dejlqcuabk ) View more	Positive	17 Oct 2025
				vemurafenib + cobimetinib (V+C)	pzlnohiner(szklpftghl) = htgvnlucyt kfpepkuifn (dejlqcuabk ) View more
NCT04940052 (ESMO2025)	Phase 3	Refractory Thyroid Gland Carcinoma BRAF V600E	153	Dabrafenib plus trametinib (D+T)	qvzpvxzeuz(mxsklxipkn) = cfjvbgcgww bchxkiaspv (yvnuvmjnvq ) View more	Positive	17 Oct 2025
				Placebo	qvzpvxzeuz(mxsklxipkn) = gqxlkvitwa bchxkiaspv (yvnuvmjnvq ) View more
ESMO2025	Not Applicable	Metastatic melanoma BRAF mutations	751	Dabrafenib/trametinib	radyxrimbf(amtqoknyub) = jyeiexfbmn xlwjefkzzr (hmaivwzyod ) View more	Negative	17 Oct 2025
				Encorafenib/binimetinib	radyxrimbf(amtqoknyub) = zkrrwkgtsg xlwjefkzzr (hmaivwzyod ) View more