Tafinlar

(Dabrafenib)

ApprovedSmall molecule

Dabrafenib is used to treat certain types of skin cancer (melanoma) and lung cancer that have a specific genetic mutation called BRAF V600E. It works by blocking a protein that helps cancer cells grow.[2] Tafinlar is currently approved and in use across 37 indications[4].[1]

Tafinlar is one of 596 small molecule programs targeting BRAF V600 Mutation. It is currently in Approved.

Indications

134

Total Trials

Active Trials

595

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

BRAF V600 MutationRecruiting

Kidney DiseaseApproved

Brain NeoplasmApproved

Lung CancerApproved

Liver DiseaseApproved

Malignant GliomaApproved

Undifferentiated CarcinomaApproved

Papillary Thyroid CarcinomaActive, not recruiting

MelanomaCompleted

Erectile DysfunctionActive, not recruiting

BRAF V600 MutationPhase 2

Recruiting

Kidney DiseaseApproved

Approved

Brain NeoplasmApproved

Approved

Lung CancerApproved

Approved

Liver DiseaseApproved

Approved

Malignant GliomaApproved

Approved

Undifferentiated CarcinomaApproved

Approved

Papillary Thyroid CarcinomaPreclinical

Active, not recruiting

MelanomaApproved

Completed

Erectile DysfunctionPreclinical

Active, not recruiting

Showing 10 of 37 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Tafinlar

Novartis

Approved

2 2

Emtriva

Gilead

Preclinical

1 3

Lamprene

Novartis

Preclinical

1 4

Levulan

Sun Pharmaceutical Industries, Inc.

Preclinical

1 5

Theo-Dur

Pfizer

Preclinical

1 6

Alfenta

Jazz Pharmaceuticals

Preclinical

1 7

Foscavir

CClinigen, Inc.

Preclinical

6 8

Brevibloc

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 9

Reminyl

WWim Janssens

Preclinical

1 10

Crixivan

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Recruiting

Erectile Dysfunction

NCT06532149

Q4 2026

Phase 2Active, not recruiting

Thyroid Gland Anaplastic Carcinoma

NCT04675710

ApprovedActive, not recruiting

Diffuse Astrocytoma

NCT03975829

Phase 2Recruiting

Cancer

NCT05159245

Phase 3Active, not recruiting

Clinical Stage III Cutaneous Melanoma AJCC V8

NCT02224781

Phase 2Active, not recruiting

Treatment

NCT04439292

Clinical

Trials by Indication[1]

Melanoma44 trials

Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT01940809·15 enrolled

Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02910700·52 enrolled

A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma

Completed· Novartis logo

Novartis·Phase 3·NCT01584648·423 enrolled

Show 41 more trials

Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT04310397·4 enrolled

Adjuvant Dabrafenib (GSK2118436) in Patients With Surgically Resected AJCC Stage IIIC Melanoma Characterized by a BRAFV600E/K Mutation

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01682213·23 enrolled

INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors.

Terminated·MMassachusetts General Hospital·Phase 1·NCT03272464·1 enrolled

Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 Mutation-Positive Melanoma

Completed· Novartis logo

Novartis·Phase 2·NCT02083354·77 enrolled

Combining Talimogene Laherparepvec With BRAF and MEK Inhibitors in BRAF Mutated Advanced Melanoma

Unknown status·WWest Cancer Center·Phase 1·NCT03088176·4 enrolled

Dabrafenib Alone and in Combination With Trametinib Before Surgery in Treating Patients With Locally or Regionally Advanced Melanoma That Can Be Removed By Surgery

Terminated·VVanderbilt-Ingram Cancer Center·Phase 2·NCT01701037·13 enrolled

Melanoma Metastasized to the Brain and Steroids

Recruiting·IInge Marie Svane·Phase 2·NCT03563729·80 enrolled

Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients

Withdrawn·UUniversity of Louisville·Phase 1/2·NCT02143050

Retrospective Assessment of Adverse Events-related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma

Completed· Novartis logo

Novartis··NCT05714371·618 enrolled

MELAFERT: Impact of Adjuvant Therapy on FERTility in Patients With Resected MELAnoma at High Risk of Relapse.

Recruiting·IIntergruppo Melanoma Italiano··NCT07092670·270 enrolled

Observational Study for Melanoma Adjuvant Treatment With Tafinlar® + Mekinist® (Dabrafenib + Trametinib)

Completed· Novartis logo

Novartis··NCT04547946·3 enrolled

BRAF-/MEK-Inhibition With Dabrafenib and Trametinib in Melanoma Patients

Completed·EEuMelaReg gGmbH··NCT03944356·232 enrolled

Dabrafenib, Trametinib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma

Completed·—·Phase 1/2·NCT02257424·50 enrolled

Pharmacokinetics of Repeat Oral Doses of Dabrafenib and the Combination of Dabrafenib and Trametinib in Chinese Subjects With Melanoma

Withdrawn· GSK logo

GSK·Phase 1·NCT02447939

MCS110 With BRAF/MEK Inhibition in Patients With Melanoma

Completed·—·Phase 1/2·NCT03455764·6 enrolled

Clinical Trial of Phenformin in Combination With BRAF Inhibitor + MEK Inhibitor for Patients With BRAF-mutated Melanoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT03026517·18 enrolled

Study of Dabrafenib +/- Trametinib in Combination With Ipilimumab for V600E/K Mutation Positive Metastatic or Unresectable Melanoma

Completed· GSK logo

GSK·Phase 1·NCT01767454·38 enrolled

A Clinical Trial of Patients With Melanoma

Withdrawn·UUniversity of Texas Southwestern Medical Center·Phase 1·NCT02915666

Concurrent Dabrafenib + Trametinib With Sterotactic Radiation in BRAF Mutation-Positive Malignant Melanoma and Brain Metastases

Terminated·CCanadian Cancer Trials Group·Phase 2·NCT02974803·6 enrolled

Dabrafenib and Trametinib With Radiosurgery in Melanoma Brain Mets

Terminated·UUniversity of California, San Francisco·Phase 2·NCT01721603·2 enrolled

A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

Terminated· Novartis logo

Novartis·Phase 3·NCT02967692·568 enrolled

A Study of the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With Trametinib and Dabrafenib in Participants With Advanced Melanoma (MK-3475-022/KEYNOTE-022)

Completed· Merck & Co. logo

Merck & Co.·Phase 1/2·NCT02130466·184 enrolled

Dabrafenib/Trametinib/Hydroxychloroquine for Advanced Pretreated BRAF V600 Mutant Melanoma

Unknown status·UUniversitair Ziekenhuis Brussel·Phase 1/2·NCT03754179·63 enrolled

Adjuvant Dabrafenib and Trametinib Treatment in Patients With Completely Resected High-risk Stage III Melanoma.

Completed· Novartis logo

Novartis··NCT04961619·39 enrolled

Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT02097225·22 enrolled

Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection

Active, not recruiting· Novartis logo

Novartis··NCT04666272·78 enrolled

Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes

Completed· Novartis logo

Novartis·Phase 3·NCT03551626·552 enrolled

Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).

Completed· Novartis logo

Novartis·Phase 3·NCT01682083·870 enrolled

TraMel-WT: A Trial of Trametinib in Patients With Advanced Pretreated BRAFV600 Wild-type Melanoma

Completed·UUniversitair Ziekenhuis Brussel·Phase 2·NCT04059224·45 enrolled

Biopsy- and Biology-driven Optimization of Targeted Therapy in Subjects With Advanced Melanoma

Terminated·PProf. Dr. med. Dirk Schadendorf·Phase 2·NCT02410863·10 enrolled

Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain

Completed· Novartis logo

Novartis·Phase 2·NCT02039947·127 enrolled

Study Comparing Pembrolizumab With Dual MAPK Pathway Inhibition Plus Pembrolizumab in Melanoma Patients

Unknown status·TThe Netherlands Cancer Institute·Phase 2·NCT02625337·32 enrolled

Dabrafenib/Trametinib, BRAF or BRAF AND MEK Pre-op With BRAF and MEK Post-op, Phase IIB, Melanoma With Brain Mets,Biomarkers and Metabolites

Terminated· GSK logo

GSK·Phase 2·NCT01978236·6 enrolled

pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE

Unknown status·MMelanomaPRO, Russia··NCT05171374·500 enrolled

A Study of APR-246 in Combination With Dabrafenib in Resistant Patients With BRAF V600 Mutant Melanoma

Terminated·AAprea Therapeutics·Phase 1/2·NCT03391050·3 enrolled

Compassionate Use Program BRAF Mutation-positive Patients in the Adjuvant Treatment of Melanoma After Surgical Resection

No longer available· Novartis logo

Novartis··NCT04544202

Study of the Variations of Albumin Level for Patients With Unresecable Stage IIIc or Stage IV Melanoma Treated by Anti BRAF and Anti MEK

Completed·PPoitiers University Hospital··NCT03553329·20 enrolled

Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma

Withdrawn·TTriHealth Inc.·Phase 2·NCT03972046

Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study

Recruiting· Novartis logo

Novartis·Approved·NCT03340506·100 enrolled

A Phase II, Randomised, Open Label Study of Neoadjuvant Dabrafenib, Trametinib and / or Pembrolizumab in BRAF V600 Mutant Resectable Stage IIIB/C/D (Excluding In-transit) Melanoma

Active, not recruiting·MMelanoma Institute Australia·Phase 2·NCT02858921·60 enrolled

An Open Label, Single Centre, Phase II Pilot Study of Neoadjuvant Dabrafenib + Trametinib in Patients With Resectable American Joint Committee on Cancer (AJCC) Stage IIIB-C BRAF V600 Mutation Positive Melanoma

Completed·MMelanoma Institute Australia·Phase 2·NCT01972347·35 enrolled

Thyroid Cancer11 trials

Dabrafenib and Trametinib Combination as a Neoadjuvant Strategy in BRAF-positive Anaplastic Thyroid Cancer

Withdrawn·SSaint Petersburg State University, Russia·Phase 2·NCT04739566

Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer

Recruiting·—·Phase 1·NCT03975231·6 enrolled

Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study

Not yet recruiting·FFujian Medical University·Phase 4·NCT07010393·335 enrolled

Show 8 more trials

Study of the Rechallenge Concept in Patients With BRAF-positive Anaplastic Thyroid Cancer After Progression on Anti-BRAF Therapy

Recruiting·SSaint Petersburg State University, Russia·Phase 2·NCT06362694·10 enrolled

Efficacy of Organoid-Based Drug Screening to Guide Treatment for Locally Advanced Thyroid Cancer

Recruiting·WWest China Hospital·Phase 2·NCT06482086·75 enrolled

A Retrospective and Prospective Real-world Study of Molecular Typing in the Treatment of Advanced Thyroid Cancer

Recruiting·FFudan University·Phase 4·NCT06195228·800 enrolled

Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer

Completed·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT03244956·40 enrolled

Dabrafenib With or Without Trametinib in Treating Patients With Advanced Differentiated Thyroid Cancer

Completed·BBhavana Konda·Phase 2·NCT01723202·53 enrolled

A Prospective, Multi-Centre Trial of TKI Redifferentiation Therapy in Patients With RAIR Thyroid Cancer (I-FIRST Study)

Unknown status·OOlivia Newton-John Cancer Research Institute·Phase 2·NCT05182931·80 enrolled

Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT01947023·21 enrolled

Phase II Study of PDR001 in Combination With MAPK Pathway Inhibitors in Patients With Radioiodine-Refractory Thyroid Cancer

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04544111·19 enrolled

Metastatic Melanoma11 trials

Radiotherapy & Combi in Metastatic Melanoma

Completed·MMelanoma and Skin Cancer Trials Limited·Phase 1/2·NCT02392871·10 enrolled

BGB324 in Combination With Pembrolizumab or Dabrafenib/Trametinib in Metastatic Melanoma

Completed·HHaukeland University Hospital·Phase 1/2·NCT02872259·74 enrolled

Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US

Completed· Pfizer logo

Pfizer··NCT05260684·716 enrolled

Show 8 more trials

"Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients: a Prospective Phase II, Open Label, Multicentre Study - (Bioliquid TAILOR Study - BIOTAILOR)"

Withdrawn·UUnknown Sponsor·Phase 2·NCT05299580

Compassionate Use Program to Access Trametinib and Dabrafenib for Patients With BRAF Mutation-positive Metastatic Melanoma

No longer available· Novartis logo

Novartis··NCT04489433

Continuous vs Intermittent Dabrafenib Plus Trametinib in BRAFV600 Mutant Stage 3 Unresectable or Metastatic Melanoma

Completed·—·Phase 2·NCT03352947·79 enrolled

Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma

Recruiting·RRina Plattner·Phase 1·NCT04903119·30 enrolled

A Phase 1b/2a Study Evaluating AMG 232 in Metastatic Melanoma

Completed·KKartos Therapeutics, Inc.·Phase 1·NCT02110355·31 enrolled

E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma

Terminated·MMayo Clinic·Phase 1·NCT05388877·13 enrolled

Evaluation of Photosensitivity in Dabrafenib or Vemurafenib Treated Metastatic Melanoma Patients - a Phase IIa/IIb Study

Terminated·UUniversity Hospital Tuebingen·Phase 2·NCT02052193·8 enrolled

A Phase II Trial of Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Patients With Unresectable or Metastatic Melanoma

Active, not recruiting·MMassachusetts General Hospital·Phase 2·NCT03149029·16 enrolled

Ameloblastoma4 trials

Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma

Unknown status·SShandong University·Phase 3·NCT06264778·10 enrolled

Neoadjuvant Therapy With Conservative Surgery vs. Up-front Conservative Surgery for BRAF V600E-Mutated Ameloblastoma

Not yet recruiting·SShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University·Phase 2/3·NCT06819605·46 enrolled

Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma

Completed·SStanford University·Phase 2·NCT02367859·1 enrolled

Show 1 more trial

Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma

Recruiting·SShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University·Phase 2·NCT06653517·12 enrolled

Colorectal Cancer3 trials

A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer

Terminated· Novartis logo

Novartis·Phase 1·NCT04294160·122 enrolled

Dabrafenib + Trametinib + PDR001 In Colorectal Cancer

Unknown status·MMassachusetts General Hospital·Phase 2·NCT03668431·25 enrolled

BRAF/MEK/EGFR Inhibitor Combination Study in Colorectal Cancer (CRC)

Completed· Novartis logo

Novartis·Phase 1/2·NCT01750918·166 enrolled

50 more indications

BRAF V600 Mutation3 trials

A Pharmacokinetics (PK) Study of the Effects Rabeprazole and Rifampin on Dabrafenib in Subjects With BRAF V600 Mutation Positive Tumors

Completed· GSK logo

GSK·Phase 1·NCT01954043·23 enrolled

Dabrafenib and Trametinib in Treating Patients With Erdheim Chester Disease With BRAF V600 Mutations

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT03794297

A Phase 2 De-escalation Study of Dabrafenib and Trametinib for Patients With BRAF V600 Mutant Low-Grade Gliomas

Recruiting·UUniversity of California, San Francisco·Phase 2·NCT07110246·96 enrolled

Cutaneous Melanoma3 trials

Japan PhI/II of GSK2118436 and GSK1120212 Combination in Subjects With BRAF V600E/K Mutation Positive Advanced Solid Tumors (Phase I Part) or Cutaneous Melanoma (Phase II Part)

Completed· GSK logo

GSK·Phase 2·NCT01928940·12 enrolled

Access Study of Trametinib for Subjects With Advanced Unresectable (Stage IIIc) or Distant Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma

No longer available· GSK logo

GSK··NCT02416232

Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma

Completed· Novartis logo

Novartis·Phase 3·NCT01597908·704 enrolled

Combination Therapy2 trials

Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers

Completed· Novartis logo

Novartis·Phase 2·NCT02034110·206 enrolled

Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC

Withdrawn· Novartis logo

Novartis·Phase 2·NCT02672358

Treatment2 trials

Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol H)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04439292·35 enrolled

Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion

Recruiting·TTianjin Medical University Second Hospital·Phase 2·NCT06739395·300 enrolled

Non-Small Cell Lung Cancer2 trials

Managed Access Program Cohort Treatment Plan CTMT212X2002I to Provide Access to Trametinib and Dabrafenib Combination Therapy for Patients With BRAF V600 Mutation-positive Advanced Non-Small Cell Lung Cancer

No longer available· Novartis logo

Novartis··NCT04507919

Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer.

Completed· Novartis logo

Novartis·Phase 2·NCT01336634·177 enrolled

Trial2 trials

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Low Grade Glioma2 trials

Phase I/II Trial of Dabrafenib, Trametinib, and Hydroxychloroquine (HCQ) for BRAF V600E-mutant or Trametinib and HCQ for BRAF Fusion/Duplication Positive or NF1-associated Recurrent or Progressive Gliomas in Children and Young Adults

Active, not recruiting·PPediatric Brain Tumor Consortium·Preclinical·NCT04201457·57 enrolled

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

Recruiting·AAnn & Robert H Lurie Children's Hospital of Chicago·Preclinical·NCT06712875·27 enrolled

Clinical Stage IV Cutaneous Melanoma AJCC v82 trials

Phase 1/2 Study of an EZH2 Inhibitor (Tazemetostat) in Combination With Dual BRAF/MEK Inhibition in Patients With BRAF- Mutated Metastatic Melanoma Who Progressed on Prior BRAF/MEK Inhibitor Therapy

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT04557956·16 enrolled

The BAMM2 (BRAF, Autophagy, MEK Inhibition in Melanoma) Study: A Randomized Double Blind Phase II Study of Dabrafenib and Trametinib With or Without Hydroxychloroquine in Advanced BRAF V600E/K Melanoma With Elevated LDH

Terminated·EECOG-ACRIN Cancer Research Group·Phase 2·NCT04527549·5 enrolled

Clinical Stage III Cutaneous Melanoma AJCC v82 trials

DREAMseq (Doublet, Randomized Evaluation in Advanced Melanoma Sequencing) a Phase III Trial

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT02224781·267 enrolled

Phase I/II Study of Dabrafenib, Trametinib, and Navitoclax in BRAF Mutant Melanoma (Phase I and II) and Other Solid Tumors (Phase I Only)

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT01989585·75 enrolled

Metastatic NSCLC1 trial

A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC

Completed· Novartis logo

Novartis·Phase 2·NCT04452877·40 enrolled

Pilot Study1 trial

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Terminated·PPeter MacCallum Cancer Centre, Australia·N/A·NCT04801966·3 enrolled

Renal Impairment1 trial

Pharmacokinetics of Dabrafenib in Subjects With Renal Impairment

Completed· Novartis logo

Novartis·Phase 1·NCT02852239·22 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Precision Therapy in Refractory Tumor

Unknown status·BBaodong Qin·Phase 2·NCT03239015·300 enrolled

Craniopharyngioma1 trial

Treatment of BRAF ( B-Rapidly Accelerated Fibrosarcoma) Mutated Papillary Craniopharyngioma

Recruiting·EEva Marie Erfurth, MD, PhD·Phase 2·NCT05525273·25 enrolled

BRAF1 trial

Dabrafenib and Trametinib for BRAF-inhibitor Pretreated Patients

Completed·UUniversitair Ziekenhuis Brussel·Phase 2·NCT02296996·25 enrolled

Targeted Therapy1 trial

NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study)

Recruiting·LLeiden University Medical Center·Phase 2·NCT06079333·20 enrolled

Unresectable1 trial

Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

Recruiting·SSun Yat-sen University·Phase 2·NCT06563999·120 enrolled

Thyroid Carcinoma1 trial

Clinical Trial in RAI-Refractory Thyroid Carcinoma Evaluating BRAF & MEK Blockade for Re-differentiation Therapy

Unknown status·NNational University Hospital, Singapore·Phase 2·NCT04554680·5 enrolled

Stage III1 trial

Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT01902173·27 enrolled

MET Exon 14 Mutation1 trial

Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT06054191·40 enrolled

Langerhans Cell Histiocytosis1 trial

Real-world Study of Darafenib or Trametinib and Clofarabine for High-risk/Recurrent/Refractory Langerhans Cell Histiocytosis in Children

Recruiting·WWest China Second University Hospital·Phase 2·NCT07022834·20 enrolled

BRAF V600E Mutation1 trial

Dabrafenib and Trametinib in People With BRAF V600E Mutation Positive Lesions in Erdheim Chester Disease

Completed·NNational Human Genome Research Institute (NHGRI)·Phase 2·NCT02281760·9 enrolled

Phase 11 trial

Phase 1 Safety and Tolerability of MEDI4736 in Combination With Dabrafenib and Trametinib or With Trametinib Alone

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02027961·68 enrolled

Advanced Solid Tumor1 trial

Dabrafenib Plus Trametinib in Patients With Advanced Solid Tumor Having BRAF V600E Mutation or Clinically Actionable BRAF Gene Alterations

Recruiting·SSe Jun Park·Phase 2·NCT05876806·30 enrolled

Cancer1 trial

The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs

Recruiting·HHelsinki University Central Hospital·Phase 2·NCT05159245·250 enrolled

Hepatic Impairment1 trial

Pharmacokinetics of Dabrafenib in Subjects With Hepatic Impairment

Terminated· Novartis logo

Novartis·Phase 1·NCT02873650·5 enrolled

Patients With Solid Tumors1 trial

Dabrafenib in Treating Patients With Solid Tumors and Kidney or Liver Dysfunction

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT01907802·8 enrolled

Advanced Malignant Tumors1 trial

Dabrafenib and Pazopanib Hydrochloride in Treating Patients With Advanced Malignant Tumors

Completed·MManisha Shah·Phase 1·NCT01713972·23 enrolled

Monotherapy1 trial

Phase II Biomarker Study Comparing the Combination of BRAF Inhibitor Dabrafenib With MEK Inhibitor Trametinib Versus the Combination After Monotherapy With Dabrafenib or Trametinib

Terminated· GSK logo

GSK·Phase 2·NCT02314143·48 enrolled

Anti-PD-1 Antibody1 trial

Study of the Anti-PD-1 Antibody Nivolumab in Combination With Dabrafenib and/or Trametinib

Withdrawn·UUniversity of Pittsburgh·Phase 1·NCT02357732

Single Dose1 trial

Effects of Dabrafenib on the Single Dose Pharmacokinetics (PK) of Rosuvastatin and Midazolam

Completed· GSK logo

GSK·Phase 1·NCT02082665·6 enrolled

Adolescent1 trial

A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects

Completed· Novartis logo

Novartis·Phase 1/2·NCT01677741·85 enrolled

Cancers1 trial

Precision Cancer Therapy in Rare Cancers

Recruiting·OOslo University Hospital·Phase 2·NCT06119789·96 enrolled

Relapsed or Refractory1 trial

Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors

Completed· Novartis logo

Novartis·Phase 2·NCT02684058·151 enrolled

Erectile Dysfunction1 trial

ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer

Recruiting·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT06532149·80 enrolled

Plexiform Neurofibroma1 trial

Study to Investigate Safety, Pharmacokinetic (PK), Pharmacodynamic (PD) and Clinical Activity of Trametinib in Subjects With Cancer or Plexiform Neurofibromas and Trametinib in Combination With Dabrafenib in Subjects With Cancers Harboring V600 Mutations

Completed· Novartis logo

Novartis·Phase 1/2·NCT02124772·139 enrolled

Advanced Solid Tumors1 trial

JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations

Suspended·JJS InnoPharm, LLC·Phase 1·NCT04418167·71 enrolled

Stage III Cutaneous Melanoma AJCC v71 trial

A Randomized Phase II Trial of Intermittent Versus Continuous Dosing of Dabrafenib (NSC-763760) and Trametinib (NSC-763093) in BRAF V600E/K Mutant Melanoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02196181·280 enrolled

Lymphoma, Non-Hodgkin1 trial

Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Recruiting·AAmerican Society of Clinical Oncology·Phase 2·NCT02693535·4,200 enrolled

Advanced Lymphoma1 trial

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

Diffuse Astrocytoma1 trial

An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)

Active, not recruiting· Novartis logo

Novartis·Approved·NCT03975829·163 enrolled

Haematological Malignancy1 trial

DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and TYA Patients With BRAF V600 Mutation-Positive Cancers.

Recruiting·CCancer Research UK·Preclinical·NCT07440290·30 enrolled

Thyroid Gland Anaplastic Carcinoma1 trial

Pembrolizumab in Combination With Dabrafenib and Trametinib as a Neoadjuvant Strategy Prior to Surgery in BRAF-Mutated Anaplastic Thyroid Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT04675710·30 enrolled

Stage IIIB Cutaneous Melanoma AJCC v71 trial

Neoadjuvant and Adjuvant Dabrafenib and Trametinib in Patients With Clinical Stage III Melanoma (Combi-Neo)

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02231775·58 enrolled

Refractory Differentiated Thyroid Gland Carcinoma1 trial

A Randomized Phase III Study of BRAF-Targeted Therapy vs Cabozantinib in RAI-Refractory Differentiated Thyroid Cancer With BRAF V600Em

Recruiting·EECOG-ACRIN Cancer Research Group·Phase 3·NCT06475989·264 enrolled

Multiple Myeloma1 trial

An Open-label, Pilot Study of Dabrafenib and/or Trametinib in Patients With Relapsed and/or Refractory Multiple Myeloma

Active, not recruiting·MMassachusetts General Hospital·Phase 1·NCT03091257·30 enrolled

Anaplastic Astrocytoma1 trial

A Phase 2 Study of Dabrafenib (NSC# 763760) With Trametinib (NSC# 763093) After Local Irradiation in Newly-Diagnosed BRAF V600-Mutant High-Grade Glioma (HGG)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03919071·58 enrolled

Malignant Solid Tumor1 trial

MegaMOST - A Multicenter, Open-label, Biology Driven, Phase II Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations /Characteristics in Advanced / Metastatic Tumors.

Recruiting·CCentre Leon Berard·Phase 2·NCT04116541·455 enrolled

Anaplastic Thyroid Cancer1 trial

A Pilot Study of the Addition of Cemiplimab, an Antibody to PD-1, to the Treatment of Subjects With BRAF-Mutant Anaplastic Thyroid Cancer Who Are No Longer Responding to Dabrafenib and Trametinib

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04238624·16 enrolled

Differentiated Thyroid Carcinoma1 trial

A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer (DTC)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT04940052·153 enrolled

Regulatory

FDA Approval Timeline[5]

May 29, 2013

TAFINLAR

NDA NDA202806

Mar 16, 2023

TAFINLAR

NDA NDA217514

Sources

References

[1]
ClinicalTrials.gov — 134 trial records for Dabrafenib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tafinlar drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Dabrafenib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Dabrafenib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA217514). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Tafinlar. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serine/threonine-Protein Kinase B-RAF Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[6]

Patent Cliff

May 4, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9233956May 4, 2029

9233956*PEDNov 4, 2029

7994185Jan 20, 2030

8415345Jan 20, 2030

7994185*PEDJul 20, 2030

8 more patents

8415345*PEDJul 20, 2030

8703781Oct 15, 2030

8952018*PEDApr 15, 2031

8703781*PEDApr 15, 2031

10869869Aug 30, 2033

10869869*PEDFeb 28, 2034

11504333Jun 29, 2038

11504333*PEDDec 29, 2038

Tafinlar

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Melanoma44 trials

Thyroid Cancer11 trials

Metastatic Melanoma11 trials

Ameloblastoma4 trials

Colorectal Cancer3 trials

BRAF V600 Mutation3 trials

Cutaneous Melanoma3 trials

Combination Therapy2 trials

Treatment2 trials

Non-Small Cell Lung Cancer2 trials

Trial2 trials

Low Grade Glioma2 trials

Clinical Stage IV Cutaneous Melanoma AJCC v82 trials

Clinical Stage III Cutaneous Melanoma AJCC v82 trials

Metastatic NSCLC1 trial

Pilot Study1 trial

Renal Impairment1 trial

Efficacy and Safety1 trial

Craniopharyngioma1 trial

BRAF1 trial

Targeted Therapy1 trial

Unresectable1 trial

Thyroid Carcinoma1 trial

Stage III1 trial

MET Exon 14 Mutation1 trial

Langerhans Cell Histiocytosis1 trial

BRAF V600E Mutation1 trial

Phase 11 trial

Advanced Solid Tumor1 trial

Cancer1 trial

Hepatic Impairment1 trial

Patients With Solid Tumors1 trial

Advanced Malignant Tumors1 trial

Monotherapy1 trial

Anti-PD-1 Antibody1 trial

Single Dose1 trial

Adolescent1 trial

Cancers1 trial

Relapsed or Refractory1 trial

Erectile Dysfunction1 trial

Plexiform Neurofibroma1 trial

Advanced Solid Tumors1 trial

Stage III Cutaneous Melanoma AJCC v71 trial

Lymphoma, Non-Hodgkin1 trial

Advanced Lymphoma1 trial

Diffuse Astrocytoma1 trial

Haematological Malignancy1 trial

Thyroid Gland Anaplastic Carcinoma1 trial

Stage IIIB Cutaneous Melanoma AJCC v71 trial

Refractory Differentiated Thyroid Gland Carcinoma1 trial

Multiple Myeloma1 trial

Anaplastic Astrocytoma1 trial

Malignant Solid Tumor1 trial

Anaplastic Thyroid Cancer1 trial

Differentiated Thyroid Carcinoma1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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