Tafinlar: a new option for BRAF V600 mutation-positive advanced melanoma

Tafinlar (dabrafenib) is indicated as monotherapy for BRAF V600 mutation-positive unresectable or metastatic melanoma.

Tafinlar (dabrafenib) is not recommended in patients with wild-type BRAF melanoma.
Tafinlar (dabrafenib) is not recommended in patients with wild-type BRAF melanoma.

PHARMACOLOGY

Dabrafenib selectively binds to and inhibits V600 mutant forms of the BRAF protein. BRAF is involved in the mitogen-activated protein kinase (MAPK) pathway, which regulates the normal growth and death of cells, including skin cells. Oncogenic mutations in BRAF lead to constitutive activation of this pathway and proliferation of tumour cells.1

The most commonly observed BRAF mutation is V600E, which accounts for approximately 90% of BRAF mutations seen in melanoma.1

CLINICAL STUDIES

In the phase III BREAK-3 trial, 250 patients with BRAF V600E mutation-positive unresectable or metastatic melanoma were randomised to receive dabrafenib or dacarbazine. The primary endpoint was progression-free survival (PFS).1

In the initial analysis (median follow-up time 4.9 months) a statistically significant improvement in PFS was observed in patients treated with dabrafenib compared with dacarbazine (HR 0.30, 95% CI 0.18–0.51; p<0.0001).1

In the updated analysis (median 10.5 months), a similar statistically significant improvement in median PFS was observed: 6.9 months in the dabrafenib arm compared with 2.7 months in the dacarbazine arm, (HR 0.37, 95% CI 0.24–0.58;p<0.0001). Median overall survival was 18.2 months for dabrafenib and 15.6 months for dacarbazine (HR.2

The most common adverse effects with dabrafenib were hyperkeratosis, headache, pyrexia, arthralgia, fatigue, nausea, vomiting, papilloma, alopecia and rash.1

References:

  1. Tafinlar Summary of Product Characteristics, August 2013.
  2. Hauschild A et al. Presentation at Annual Meeting of the American Society of Clinical Oncology, Chicago, US, May-June 2013; abstract 9013.

View Tafinlar drug record

Further information: GlaxoSmithKline

Follow MIMS on Twitter


MIMS Clinics

Prescribing news and resources for key therapeutic areas, collated by the MIMS editors.

Register or Subscribe to MIMS

GPs can get MIMS print & online and GPonline for free when they register online – take 2 minutes, and make sure you get your free MIMS access! If you're not a GP, you can subscribe to MIMS for full access.

Register or subscribe

MIMS bulletins

News and updates straight to your inbox.

Prescribing Update: Fortnightly news bulletin
Alert:
Urgent prescribing updates
Spotlight: Disease-themed monthly round-up

Sign me up

MIMS Dermatology

Read the latest issue online exclusively on MIMS Learning.

Read MIMS Dermatology

Mobile apps

MIMS: access the full drug database and quick-reference tables on the go

MIMS Diagnosis and Management: concise information on signs and symptoms, investigations and diseases

Promo Image

Clinical calculators

Handy calculators and conversions for primary care.