Tafinlar® (dabrafenib mesilate) registered for the treatment of metastatic melanoma in Australia
03 September 2013
Tafinlar® (dabrafenib) has been approved by the Therapeutics Goods Administration (TGA) in Australia for the treatment of patients with BRAF V600 mutation positive melanoma that is unresectable (cannot be removed by surgery) or metastatic (has spread to other parts of the body).
Tafinlar® (dabrafenib) has been approved by the Therapeutics Goods Administration (TGA) in Australia for the treatment of patients with BRAF V600 mutation positive melanoma that is unresectable (cannot be removed by surgery) or metastatic (has spread to other parts of the body).1-3
BRAF is a key component of the MAPK pathway which regulates the normal growth and death of cells, including skin cells.4 In approximately 50% of melanomas, a mutated BRAF protein disrupts normal signalling in the MAPK pathway and results in uncontrolled cell growth.2 Tafinlar® binds to the mutated BRAF protein to interfere with signalling, which may slow or stop the growth of tumour cells.2
Dr Andrew Yeates, GSK’s Medical Director in Australia, said that the approval of Tafinlar® represented an important step in GSK's ongoing efforts to develop new treatment options for melanoma patients.
“We are very excited to have brought this new compound to market in less than five years after our initial testing,” said Dr Yeates.
“With this new personalised approach to medical oncology, we hope to make a meaningful difference in the lives of appropriate patients with metastatic melanoma.” said Dr Yeates.
The most common adverse events (affecting more than 1 in 10 people) reported in clinical studies of Tafinlar in adults include thickening of the outer layers of the skin, skin effects (such as rash, wart-like growths, or redness and swelling of the palms, fingers and soles of the feet), headache, nausea, vomiting, or diarrhoea, decreased appetite, chills, feeling weak, lack of energy, fever, joint pain, muscle pain, or pain in the hands or feet, cough, unusual hair loss or thinning.
Precautions: Patients should be routinely monitored for eye problems during therapy. Efficacy and safety not established in wild-type BRAF melanoma. Pyrexia (fever), cutaneous squamous cell carcinoma, new primary melanoma, non-cutaneous malignancy, pancreatitis, hyperglycaemia (high sugar levels in blood), renal failure, effects on fertility, pregnancy (category D), lactation, paediatric use, use in elderly, genotoxicity and carcinogenicity.
Interactions: Birth control using hormones such as pills, injections or patches, warfarin, medicines to treat fungal infections, some antibiotic medicines, some immunosuppressants, medicines that reduce stomach acid, some anti-inflammatory medicines, some medicines to treat HIV, medicines to treat seizures, anti-depressant medicines and herbal medicine.
Contraindications: Hypersensitivity to dabrafenib mesilate or any excipients
For further information about metastatic melanoma and treatment options, please speak to your healthcare professional. For Consumer Medicine information (CMI) on Tafinlar®, please see www.gsk.com.au
PBS Information: This product is not available on the PBS
GlaxoSmithKline Australia Pty Ltd. ABN 47 100 162 481. Melbourne, VIC. Contact us on www.gsk.com.au or Ph:
1800 033 109. Tafinlar® is a registered trade mark of the GlaxoSmithKline group of companies.
AUS/MEK/0011/13 Date of Approval August 2013
1. Australian Register of Therapeutic Goods, http://www.tga.gov.au/industry/artg.htm, (accessed 28 Aug 2013)
2. Tafinlar Approved Product Information
3. Tafinlar Approved Consumer Medicine Information
4. National Library of Medicine. “Genetics Home Reference” Available at http://ghr.nlm.nih.gov/gene/BRAF (accessed Aug 2013).