Tafinlar (dabrafenib)
/ Novartis, BeOne Medicines
- LARVOL DELTA
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July 31, 2026
Real-World Treatment Patterns and Outcomes for BRAFV600E-mutated Metastatic Non-Small Cell Lung Cancer: OCTOPUS Study
(IASLC-WCLC 2026)
- P | "In 1L, 37.3% (n=50) received dabrafenib + trametinib (DT; a BRAF/MEK inhibitor combination), 27.6% received pembrolizumab (P) alone (9.7%; n=13) or with chemotherapy (CT; 17.9%; n=24), 20.1% (n=27) received CT alone, and 14.9% (n=20) received other treatment types. Despite international recommendations, one-third of patients did not receive 1L or 2L BRAF/MEK inhibitor treatment, highlighting the need to optimize therapeutic strategies and treatment sequencing in patients with BRAF V600E mNSCLC. However, no definitive conclusions can be drawn due to the observational nature of this study."
Clinical • HEOR • Metastases • Real-world • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor
July 17, 2026
Effectiveness of Dabrafenib plus Trametinib as second-line therapy in comparison to first-line in BRAFV600 mutated metastatic melanoma: A Real-World Analysis
(ESMO 2026)
- No abstract available
Clinical • Metastases • Real-world • Real-world evidence • Melanoma • Oncology • Solid Tumor
August 29, 2026
Pancreatic Metastases From Metastatic Papillary Thyroid Carcinoma Presenting as Acute Pancreatitis in a Patient Receiving Dabrafenib/Trametinib
(ACG 2026)
- "Given concern for medication-related toxicity, dabrafenib and trametinib were discontinued, and she was subsequently started on lenvatinib. This case highlights how complex pancreatic pathology underscores the importance of multidisciplinary evaluation. Figure: Figure 1: MRI abdomen/pelvis showing edematous pancreas and metastatic nodules in the pancreas"
Clinical • Metastases • Oncology • Pancreatic Cancer • Pancreatitis • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma
August 29, 2026
A Rare Case of Gastric Metastatic Melanoma
(ACG 2026)
- "Targeted therapy with oral suspensions of dabrafenib and trametinib was initiated and discharged. Figure: CT Abdomen with IV contrast showing 9.5 x 7.8 x 13.8 cm (transverse by AP by craniocaudal) heterogeneous, mixed cystic and solid mass in the left upper quadrant, abutting the stomach. Figure: CT abdomen with IV contrast was notable for very large necrotic mass significantly increased in size from recent prior CT measuring approximately the 25 x 16 cm producing significant mass effect upon adjoining structures and causes new mild right hydronephrosis."
Clinical • Metastases • Anorexia • Gastrointestinal Disorder • Melanoma • Nephrology • Solid Tumor • MUC16
August 29, 2026
Ulcerative Rectosigmoid Langerhans Cell Histiocytosis Mimicking Late-Onset Inflammatory Bowel Disease
(ACG 2026)
- "She had a history of indeterminate colitis diagnosed in 2023 with patchy colonic and small bowel involvement requiring multiple targeted immune modulating (TIM) therapies including vedolizumab, Risankizumab, infliximab, adalimumab, and azathioprine...On admission, she was found to have a Clostridium difficile infection and was started on fidaxomicin with clinical response...The patient was re-started on targeted LCH therapy with dabrafenib by hematology and nutritional support via total parenteral nutrition...B: On higher magnification, the lamina propria contains patchy histiocytic infiltrates, which are accompanied by scattered eosinophils and are in close association with colonic crypts with crypt injury, cryptitis and crypt abscesses (hematoxylin-eosin stains at 200x). C: CD1a immunohistochemistry is strongly and diffusely positive in the histiocytic infiltrates, supporting the diagnosis of Langerhans cell histiocytosis (CD1a stain, 200x)."
CNS Disorders • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Langerhans Cell Histiocytosis • CD1a
August 29, 2026
Comparative Efficacy and Safety of Biomarker-Guided Targeted Therapies Versus Conventional Treatment in Advanced Biliary Tract Cancer: A Systematic Review and Network Meta-Analysis
(ACG 2026)
- "14 studies involving 3,842 patients were included, comprising 2,116 males (55.1%) and 1,726 females (44.9%), with median age ranging from 58â69 years. Evaluated therapies included FGFR inhibitors (pemigatinib, futibatinib, infigratinib), the IDH1 inhibitor ivosidenib, HER2-directed regimens (trastuzumab-based therapies and zanidatamab), dabrafenib plus trametinib, zenocutuzumab, and conventional chemotherapy/immunotherapy controls. Most patients had metastatic disease (81.6%), ECOG 0â1 status (87.3%), and prior systemic therapy exposure."
Biomarker • IO biomarker • Metastases • Retrospective data • Review • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor • FGFR2 • IDH1 • NRG1
August 29, 2026
From Melanoma to Carpeted Colon: Acquired Serrated Polyposis After Immunotherapy
(ACG 2026)
- "Melanoma was treated from 2014 to 2015 with a combination of BRAF/MEK inhibition (dabrafenib and trametinib) initially, followed by immune check point inhibitors (ICIs) (ipilimumab and pembrolizumab) and now is in oncological remission. Multidisciplinary management including early surgical consultation should be considered when endoscopic control becomes difficult or incomplete. Figure: Carpet-like, flat and mucous-capped polyps in the hepatic flexure Figure: 17 mm flat polyp in the transverse colon, injected to raise the lesion, demarcation performed with narrow band imaging for resection"
IO biomarker • Colon Cancer • Colonic Polyps • Colorectal Cancer • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology • Inflammatory Bowel Disease • Melanoma • Solid Tumor • Ulcerative Colitis
August 29, 2026
Subclinical Colonic Diverticulitis Associated With BRAF/MEK and Immune Checkpoint Inhibitors for Thyroid Cancer: A Rare Toxicity Presentation
(ACG 2026)
- "The patient was treated with dabrafenib, trametinib (BRAF and MEK inhibitors, respectively) and immune checkpoint inhibitor (ICI) pembrolizumab (anti-PD-1), achieving clinical remission. Higher magnification (10?) H&E section with abundant thin-walled capillaries and small blood vessels, fibroblasts, inflammatory cells infiltration as characteristic features of granulation tissue. No features of malignancy was identified."
Checkpoint inhibition • IO biomarker • Constipation • Gastroenterology • Gastrointestinal Disorder • Hypertension • Immunology • Inflammatory Bowel Disease • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma • BRAF
July 14, 2026
Efficacy and safety of dabrafenib plus trametinib in adults with differentiated thyroid cancer: a randomised, double-blind, placebo-controlled, phase 3 trial.
(PubMed, Lancet Oncol)
- P3 | "In previously-treated patients with locally advanced or metastatic, radioactive iodine-refractory BRAFV600E-positive differentiated thyroid cancer, dabrafenib plus trametinib showed significant benefits for progression-free survival and overall response rate, with no new safety signals. These findings support the second-line use of dabrafenib plus trametinib in patients with radioactive iodine-refractory BRAFV600E-positive differentiated thyroid cancer."
Journal • P3 data • Cardiovascular • Infectious Disease • Oncology • Pneumonia • Respiratory Diseases • Retinal Disorders • Septic Shock • Solid Tumor • Squamous Cell Carcinoma • Thyroid Gland Carcinoma
September 09, 2026
Impact of Neoadjuvant TKI Therapy on Tumor Reduction and Resectability in Locally Advanced Thyroid Carcinoma
(ETA 2026)
- "Therapies included selective (dabrafenib/trametinib, entrectinib, larotrectinib, selpercatinib) and multikinase inhibitors (lenvatinib, cabozantinib, vandetanib)... Neoadjuvant TKI therapy demonstrated promising results in locally advanced thyroid carcinoma, achieving high disease control rates and enabling surgical resection in over one-third of cases. Outcomes were comparable between selective and multikinase TKIs, and meaningful responses were observed across histological subtypes, although survival remained significantly longer in differentiated tumors. These findings, representing one of the largest single-center cohorts, reinforce the growing role of neoadjuvant therapy in multidisciplinary management of advanced thyroid cancer."
Clinical • Metastases • Oncology • Solid Tumor • Thyroid Gland Carcinoma
September 09, 2026
Treatment outcomes of multikinase and target therapy of the Portuguese cohort of Advanced Thyroid Carcinoma
(ETA 2026)
- "On first line 71% were treated with Lenvatinib and 10% Sorafenib while target therapy with Dabrafenib and Trametinib (DT) represented 18% of cases (50% in ATC cohort). This is the first national wide assessment of Portuguese thyroid cancer patients treated with oral systemic therapy. Molecular testing was performed in a significant percentage of patients and mainly before first line therapy. In DTC Lenvatinib and DT showed improved anti-tumour activity compared to Sorafenib while DT had better clinical tolerability."
Clinical • Metastases • Inherited Retinal Dystrophy • Oncology • Ophthalmology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • BRAF • NTRK
September 02, 2026
Pathologic response assessment after neoadjuvant therapy in advanced thyroid carcinoma: preliminary institutional experience
(ECP 2026)
- "NAT regimens were lenvatinib (n=2), lenvatinib plus dabrafenib/trametinib (n=1), and dabrafenib/trametinib plus radiotherapy (n=1). PRA after NAT in advanced TC is heterogeneous. The absence of standardized reporting limits comparisons across studies and hampers assessment of prognostic significance. In this preliminary series, the modified Ryan TRS appears to provide a practical and reproducible framework for evaluating NAT effect in surgical specimens, while supporting the need for validation of thyroid-specific response criteria."
Clinical • Metastases • Fibrosis • Immunology • Oncology • Solid Tumor • Thyroid Gland Carcinoma
September 09, 2026
Genetic landscape of a series of sporadic Differentiated Thyroid Carcinoma (spDTC) patients: clinical utility of Next Generation Sequencing (NGS) in therapeutic strategy
(ETA 2026)
- "In 3/7 BRAF V600E patients Dabrafenib in combination with Trametinib was initiated ( n 2 patients with partial response, n 1 patient with initially mixed response, finally succumbed to the disease). In the PTEN patient, Lenvatinib plus Pembrolizumab was initiated with mixed response for a period of 18 months before disease progression was documented. Clinical utility of NGS in aggressive DTC provides information regarding prognosis while in locally advanced and/or metastatic disease is the sine qua non of precision medicine implementation as, apart from targetable mutations, it unravels targetable rearrangements, as well."
Biomarker • Clinical • Next-generation sequencing • CNS Disorders • Oncology • Solid Tumor • Thyroid Gland Carcinoma • BRAF • ETV6 • mTOR • NCOA4 • NRAS • NTRK3 • PIK3CA • PTEN
April 21, 2026
EA3231: A randomized phase III study of BRAF-targeted therapy vs cabozantinib in RAI-refractory differentiated thyroid cancer with BRAF V600Em.
(ASCO 2026)
- P3 | " EA3231 (NCT06475989) is a NCTN cooperative group randomized phase III study in patients with BRAF V600Em RAIR DTC who have progressed on prior multikinase inhibitor therapy such as lenvatinib or sorafenib. Patients will be randomized 1:1 to BRAF-targeted therapy (dabrafenib and trametinib) or cabozantinib, all of which are FDA-approved agents in this setting...Our target accrual is 120 patients; this sample size will provide 83% power to detect a HR of 0.60 (corresponding to a median PFS of 12 months) compared to an estimated median PFS of 7.2 months in the cabozantinib arm. This study was activated in late 2024, and has enrolled 8/120 patients as of 1/2026."
Clinical • P3 data • Oncology • Solid Tumor • Thyroid Gland Carcinoma • BRAF
September 03, 2026
Marked response to dabrafenib plus trametinib in a patient with BRAF V600E-mutant pancreatic hepatoid carcinoma: a case report and systematic analysis of 57 cases.
(PubMed, Front Oncol)
- "After two cycles of pembrolizumab-based first-line therapy combined with paclitaxel, S-1, and lenvatinib, AFP continued to increase and imaging showed rapid tumor enlargement, consistent with immune checkpoint inhibitor-related hyperprogressive disease...Subsequent addition of cetuximab, replacement of the MEK inhibitor, and dose escalation of targeted therapy did not restore sustained systemic disease control, although local disease remained manageable with subsequent treatment adjustments...After resistance to targeted therapy, local radiotherapy may serve as an important strategy for controlling oligoresidual and oligometastatic lesions. Together with the literature review, this case supports early comprehensive molecular profiling and individualized multidisciplinary management for advanced PHC."
IO biomarker • Journal • Tumor mutational burden • Hepatocellular Cancer • Hepatology • Liver Failure • Oncology • Pain • Pancreatic Cancer • Solid Tumor • Thrombosis • AFP • BRAF • MDM2 • MGMT • MYC • PD-L1 • TMB
September 09, 2026
Lenvatinib vs Dabrafenib and Trametinib as First-Line Treatment for Radioactive Iodine-Refractory Differentiated Thyroid Carcinoma: A Real-World Study
(ETA 2026)
- "Backgroud: Sorafenib and Lenvatinib are the approved first-line (1L) treatments for radioactive iodine -refractory (RAIR) differentiated thyroid carcinoma (DTC). In this first series directly comparing 1L treatments for RAIR DTC, both therapies demonstrated comparable OS, DT showing a trend toward longer PFS, faster tumor response, and fewer dose adjustments. In the BRAF-mutated subgroup, efficacy outcomes were comparable while DT retained its safety advantage."
Clinical • Real-world • Real-world evidence • Inherited Retinal Dystrophy • Oncology • Ophthalmology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma
September 25, 2026
Tolerance and Efficacy of Targeted Therapies After Immunotherapy for Advanced Non-Small Cell Lung Cancers Harboring Oncogenic Alterations: The GFPC-TOXIMAD Study.
(PubMed, Curr Oncol)
- "According to this analysis, sequential ICI-targeted therapy use for advanced NSCLC appeared to be associated with more grade 3-5 AEs."
IO biomarker • Journal • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • MET
September 24, 2026
Antitumor effects of CEP32496 on urothelial carcinoma with BRAF mutation (V595E) in dogs.
(PubMed, Can J Vet Res)
- "For reference, 7 BRAF inhibitors, including GDC0879, PLX4720, encorafenib, vemurafenib, dabrafenib, AZ628, and RAF265, were also evaluated. In the xenograft model, 10 mg/kg body weight of CEP32496 resulted in a significant decrease (P < 0.05) in tumor growth in mice, with severe and extensive necrosis on histopathological examination. These results suggested that CEP32496 exerts antitumor effects on both cell proliferation and tumor growth in UC with V595E."
Journal • Oncology • Solid Tumor • Urothelial Cancer • BRAF
September 10, 2026
Predicting Targeted and Immunotherapeutic Response Outcomes in Melanoma With Single-Cell Raman Spectroscopy and Artificial Intelligence.
(PubMed, JCO Precis Oncol)
- "Single-cell Raman spectroscopy combined with ML offers a scalable, prognostic platform to predict therapeutic resistance likelihood, with further potential to advance clinical, multiomic biomarker efforts for melanoma. Our approach may improve first- and second-line therapy selection assessments for precision medicine by providing rapid, nondestructive prediction of therapeutic response based on cellular spectral profiles."
IO biomarker • Journal • Melanoma • Oncology • Solid Tumor
August 15, 2026
Tumor Plasticity and Adaptive Resistance: A Case of Chondrosarcomatous Transdifferentiation in Melanoma Brain Metastasis under BRAF-MEK Inhibition
(EANO 2026)
- "We report a striking case of BRAF-mutant melanoma exhibiting complete morphologic transformation under targeted therapy, resolved only through integrated genomic and epigenomic profiling. We report the case of a 63-year-old man with BRAF V600E-mutated cutaneous melanoma treated with the BRAF inhibitor dabrafenib (dabrafenib) and the MEK inhibitor trametinib (trametinib), whose therapy required substantial dose reductions because of toxicity. This case provides molecularly validated evidence of extreme phenotypic plasticity in BRAF-mutant melanoma brain metastasis under targeted therapy. Our findings illustrate how integrated genomic and epigenomic analyses can resolve diagnostically challenging lesions and support the hypothesis that selective therapeutic pressure may facilitate lineage reprogramming in advanced melanoma. Recognition of such plasticity is critical in the era of precision oncology, both for accurate diagnosis and for understanding mechanisms of..."
Clinical • Cutaneous Melanoma • Melanoma • Oncology • Sarcoma • Solid Tumor
July 16, 2024
Encorafenib plus binimetinib in patients (pts) with previously untreated BRAF V600E-mutant advanced non-small cell lung cancer (NSCLC): An open-label, multicenter phase II trial (IFCT-1904 ENCO-BRAF)
(ESMO 2024)
- P2 | "Current ESMO guidelines recommend dabrafenib plus trametinib as preferred first-line treatment options or as subsequent treatment for BRAFV600E-mutant advanced NSCLC. In this phase 2 trial with treatment-naïve BRAFV600E-mutant advanced NSCLC, encorafenib plus binimetinib demonstrated robust clinical activity. The safety profile was manageable and consistent with previous studies in lung cancer and melanoma."
Clinical • Metastases • P2 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF
April 25, 2024
Long-term follow up for adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma: Final results of the COMBI-AD study.
(ASCO 2024)
- P3 | "COMBI-AD presents the longest follow-up data (over 10 years) in adjuvant treatment of stage III melanoma in the modern era. OS was improved with dabrafenib plus trametinib over placebo for adjuvant treatment of stage III melanoma with a 20% risk reduction for death. However, this difference was not statistically significant."
Clinical • IO biomarker • Melanoma • Oncology • Solid Tumor • BRAF
September 15, 2026
Pharmacokinetics and efficacy of tank water-administered BRAF-inhibitor dabrafenib in a zebrafish melanoma model.
(PubMed, Dis Model Mech)
- "Continuous tank water administration achieved therapeutically relevant steady-state dabrafenib plasma levels that inhibited BRAF-driven signaling and produced robust efficacy in vivo in a genetic zebrafish model of BRAF-mutant melanoma without apparent toxicity. Together, these results demonstrate that continuous tank water administration of dabrafenib is a feasible, efficient, and well-tolerated dosing strategy in zebrafish melanoma models, and may facilitate dosing of other small molecule inhibitors, especially those with a short in vivo half-life in zebrafish."
Journal • PK/PD data • Melanoma • Oncology • Solid Tumor
June 22, 2024
Neoadjuvant pembrolizumab, dabrafenib and trametinib in BRAFV600-mutant resectable melanoma: the randomized phase 2 NeoTrio trial.
(PubMed, Nat Med)
- P2 | "Pending longer follow-up, we suggest that immunotherapy and targeted therapy should not be combined in the neoadjuvant setting for melanoma. ClinicalTrials.gov registration: NCT02858921 ."
IO biomarker • Journal • P2 data • Melanoma • Oncology • Solid Tumor • BRAF
September 09, 2026
Leptomeningeal Dissemination in TERT Promoter-mutant Anaplastic Pleomorphic Xanthoastrocytoma Responding to BRAF-MEK Inhibition: A Case Report.
(PubMed, NMC Case Rep J)
- "After spinal irradiation, dabrafenib plus trametinib was initiated, resulting in partial radiological response and symptomatic improvement. Here, we report a case of recurrent anaplastic BRAF V600E-mutant pleomorphic xanthoastrocytoma with leptomeningeal dissemination that showed a transient but clinically meaningful response to combined BRAF-MEK inhibition and spinal radiation therapy. In addition, this case raises the possibility of an association between TERT promoter mutation and leptomeningeal dissemination, although further studies are required to clarify this relationship."
Journal • Astrocytoma • Brain Cancer • Oncology • Pleomorphic Xanthoastrocytoma • Solid Tumor • TERT
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