TAFINLAR (dabrafenib) capsules, for oral use Initial U.S. Approval: 2013

TAFINLAR is a kinase inhibitor 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. TAFINLAR is indicated, in combination with trametinib, 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). Medicine Name: TAFINLAR
Generic Name: dabrafenib
Approval Date: 2013
Treatment of: Melanoma…
Company Name: Novartis Pharmaceuticals Corporation.
Source Details: Patient Information

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IPN, New Delhi can facilitate patient to import of “TAFINLAR (dabrafenib) capsules” in quantities for personal use. For this applicant is required to make an application in Form 12A, along with the prescription of the Registered Medical Practitioner (RMP).

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