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Tafinlar (dabrafenib)

Region

🇪🇺 EU

Active substance

dabrafenib

Company

Novartis Europharm Limited

Status

Authorised

Therapeutic area

Melanoma

CHMP opinion

Thu 27 Jun 2013

EU approval

Mon 26 Aug 2013

Application

EMEA/H/C/002604

ATC

L01EC02

Official record

www.ema.europa.eu

Indication

Melanoma Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). Adjuvant treatment of melanoma Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage III melanoma with a BRAF V600 mutation, following complete resection. Non-small cell lung cancer (NSCLC) Dabrafenib in combination with trametinib is indicated for the treatment of adults with advanced non-small cell lung cancer with a BRAF V600 mutation. Differentiated thyroid cancer (DTC) Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy (for biomarker-based patient selection, see section 4.2).

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Finlee Authorised · Novartis Europharm Limited

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.