ArticleDrugs2013
Dabrafenib: first global approval.
Article in Drugs, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 62 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
62 citing papers in PubMed, 2 syntheses or guidelines pooled it, 138 citations in OpenAlex.
- Prevalence of BRAFV600 in glioma and use of BRAF Inhibitors in patients with BRAFV600 mutation-positive glioma: systematic review.Neuro-oncology · 2022Pooled it
- Reliability of BRAF mutation detection using plasma sample: A systematic review and meta-analysisMedicine · 2021Pooled it
- Structural Transformation of a BRAF Inhibitor into a Selective PKR Inhibitor.Journal of medicinal chemistry · 2026Article
- MEK interactions tune RAF kinase sensitivity to conformation-selective inhibition.Nature chemical biology · 2026Article
- Review
- Data Mining for Identification of Targets and Repurposed Drugs to Eliminate Persistent Chronic Myeloid Leukaemia Stem Cells: Targeting RAS/RAF Signalling.Oncology research · 2026Article
- BRAF V600E-mutated metastatic Wilms tumor with complete response to targeted RAF/MEK inhibition: a post-treatment follow-up case report.Frontiers in oncology · 2026Article
- Advances in Cutaneous Melanoma Therapy: The Emerging Role of CDK4/6 Inhibitors.Pharmacological research · 2025Review
- Pyrimidin-4-bromobenzenesulfonamide/-4-nitrobenzenesulfonamide hybrids as potential BRAFJournal of computer-aided molecular design · 2025Article
- Integrated In Silico and Experimental Validation of Antrocin as a Plant-Derived Multi-Target Therapeutic for BRAF/MEK/PI3K-Driven Colorectal Cancer.International journal of molecular sciences · 2025Article
- Clinical features, treatment and outcomes of dabrafenib-associated uveitis.Investigational new drugs · 2025Article
- A multi-omic analysis reveals a predictive value of tertiary lymphoid structures in improving the prognosis of colorectal cancer patients with BRAF mutation.Frontiers in immunology · 2025Article
- scPharm: Identifying Pharmacological Subpopulations of Single Cells for Precision Medicine in Cancers.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Article
- RAS signaling in carcinogenesis, cancer therapy and resistance mechanisms.Journal of hematology & oncology · 2024Review
- BRAF-Mutated Melanoma Cell Lines Develop Distinct Molecular Signatures After Prolonged Exposure to AZ628 or Dabrafenib: Potential Benefits of the Antiretroviral Treatments Cabotegravir or Doravirine on BRAF-Inhibitor-Resistant Cells.International journal of molecular sciences · 2024Article
- BRAF V600E Mutation in Malignant Melanoma-A Romanian Research Experience.Medicina (Kaunas, Lithuania) · 2024Article
- Vaccine antibodies against a synthetic epidermal growth factor variant enhance the antitumor effects of inhibitors targeting the MAPK/ERK and PI3K/Akt pathways.Translational oncology · 2024Article
- Refining mutanome-based individualised immunotherapy of melanoma using artificial intelligence.European journal of medical research · 2024Review
- The evolution of BRAF-targeted therapies in melanoma: overcoming hurdles and unleashing novel strategies.Frontiers in oncology · 2024Review
- Acquired and intrinsic resistance to vemurafenib in BRAFFEBS open bio · 2024Article
2 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Dabrafenib (Tafinlar®), a mutant-BRAF kinase inhibitor, emerged from GlaxoSmithKline's research programme for the discovery of selective inhibitors of mutant BRAF kinase activity, for the treatment of solid tumours; mutations in the BRAF gene are associated with increased growth and proliferation of cancer cells. GlaxoSmithKline has focused the development of dabrafenib on the treatment of malignant melanoma, as BRAF mutations are present in 50 % of these cancers. Dabrafenib is approved in the US as a single agent treatment for unresectable or metastatic melanoma in patients with the BRAF V600E mutation, and has received a positive opinion in the EU in this indication. Submissions have also been made in the US and the EU for the use of dabrafenib in combination with trametinib for the treatment of metastatic melanoma with a BRAF V600E/K mutation. Global phase III development of dabrafenib as a monotherapy and as a combination therapy is ongoing in the treatment of malignant melanoma. Phase II development is ongoing for the treatment of malignant melanoma that has metastasised to the brain, and for colorectal and non-small cell lung cancers. Dabrafenib is intended to treat the patient population with a BRAF V600E/K mutation. GlaxoSmithKline's dabrafenib application in the US included the treatment of this population as detected by a US FDA-approved test. GlaxoSmithKline, in collaboration with bioMérieux and Response Genetics, has developed a molecular theranostic test to identify BRAF V600E/K mutations. Pre-Market approval of the test has been granted by the FDA. This article summarises the milestones in the development of dabrafenib leading to this first approval as a single agent treatment for unresectable or metastatic melanoma in patients with the BRAF V600E mutation.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.