Drugs of interest to pathologists
Drugs related to surgical pathology

Topic Completed: 1 February 2014

Minor changes: 11 December 2020

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PubMed Search: Dabrafenib [title] "loattrfree full text"[sb]

Him G. Kwee, M.D.
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Cite this page: Kwee HG. Dabrafenib. PathologyOutlines.com website. https://www.pathologyoutlines.com/topic/drugsdabrafenib.html. Accessed January 22nd, 2021.
Definition / general
  • Dabrafenib is a BRAF inhibitor
  • It interrupts the BRAF / MEK step in the BRAF / MEK / ERK pathway if the BRAF has the V600E mutation
  • If there is no BRAF mutation, it could stimulate BRAF and may promote tumor growth
Trade name
  • Tafinlar®
Clinical information
  • Kinase inhibitor approved by the U.S. Food and Drug Administration in May 2013 as a single drug for unresectable or metastatic malignant melanoma that has the BRAF V600E mutation
  • In January 2014, the FDA also granted Breakthrough Therapy designation for Dabrafenib for the treatment of patients with metastatic BRAF V600E mutation positive non small cell lung cancer who have received at least one prior line of platinum based chemotherapy
  • The FDA has also approved the test for this drug to detect the BRAF V600E and BRAF V600K mutations called THx ID - BRAF (bioMerieux S.A.), which can be performed on formalin fixed paraffin embedded tissue
  • The FDA has also approved the combination therapy of dabrafenib and trametinib (Mekinist), a MEK inhibitor, for unresectable or metastatic melanoma in January 2014
  • Cost: $7,600 per month
  • Side effects:
    • The development of new primary skin malignancies like squamous cell carcinoma, melanoma
    • Fever, hyperglycemia, nephrotoxicity, uveitis, iritis
    • Hemolytic anemia in patients with G6PD deficiency
    • Fetal malformation
    • Hemorrhage or venous thromboembolism
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