Tafinlar FDA Approval History

Last updated by Judith Stewart, BPharm on March 29, 2023.

FDA Approved: Yes (First approved May 29, 2013)
Brand name: Tafinlar
Generic name: dabrafenib
Dosage form: Capsules and Tablets for Oral Suspension
Company: Novartis Pharmaceuticals Corporation
Treatment for: Melanoma, Metastatic, Non Small Cell Lung Cancer, Thyroid Cancer, Solid Tumors, Low-Grade Glioma

Tafinlar (dabrafenib) is a kinase inhibitor for the treatment of melanoma, non-small cell lung cancer, thyroid cancer, solid tumors, and low-grade glioma with BRAF V600 mutations.

Tafinlar is an inhibitor of some mutated BRAF kinases, including the BRAF V600E and V600K mutations. Tafinlar is indicated:

• as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
• in combination with trametinib (Mekinist) for:
  • the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
  • the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
  • the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
  • the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.
  • the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.
    This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
  • the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.
• Tafinlar capsules and tablets for oral suspension are taken orally twice daily at least 1 hour before or at least 2 hours after a meal.
• Warnings and precautions associated with Tafinlar include new primary malignancies, tumor promotion in BRAF wild-type tumors, hemorrhage, cardiomyopathy, uveitis, serious febrile reactions, serious skin toxicities, hyperglycemia, glucose-6-phosphate dehydrogenase deficiency (G6PD), and embryo-fetal toxicity.
• Common adverse reactions for Tafinlar as a single agent include hyperkeratosis, headache, pyrexia, arthralgia, papilloma, alopecia, and palmar-plantar erythrodysesthesia syndrome.
  Common adverse reactions for Tafinlar with trametinib, include:
  • Unresectable or metastatic melanoma: pyrexia, rash, chills, headache, arthralgia, and cough.
  • Adjuvant treatment of melanoma: pyrexia, fatigue, nausea, headache, rash, chills, diarrhea, vomiting, arthralgia, and myalgia.
  • NSCLC: pyrexia, fatigue, nausea, vomiting, diarrhea, dry skin, decreased appetite, edema, rash, chills, hemorrhage, cough, and dyspnea.
  • Adult patients with solid tumors: pyrexia, fatigue, nausea, rash, chills, headache, hemorrhage, cough, vomiting, constipation, diarrhea, myalgia, arthralgia, and edema.
  • Pediatric patients with solid tumors: pyrexia, rash, vomiting, fatigue, dry skin, cough, diarrhea, dermatitis acneiform, headache, abdominal pain, nausea, hemorrhage, constipation, and paronychia.
  • Pediatric patients with low-grade glioma: pyrexia, rash, headache, vomiting, musculoskeletal pain, fatigue, diarrhea, dry skin, nausea, hemorrhage, abdominal pain and dermatitis acneiform.

Development timeline for Tafinlar

Further information

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