GSK’s skin cancer pill Tafinlar gets EMA approval
pharmafile | September 3, 2013 | News story | Sales and Marketing | BMS, GSK, Tafinlar, Yervoy, melanoma
GSK has been granted EMA marketing authorisation for its new metastatic melanoma drug Tafinlar.
The EMA’s decision on Tafinlar (dabrafenib) was based on the results of a Phase III clinical trial which found that the drug significantly increased progression-free survival, compared to chemotherapy.
Tafinlar is used to treat melanoma that has spread to other parts of the body (metastasised) or is otherwise inoperable.
The compound specifically targets cancer with the BRAF V600 protein mutation – a characteristic found in approximately 50% of the 2,000 new cases of metastatic melanoma identified every year in the UK.
A large proportion of people diagnosed with melanoma fall into the relatively young 15-34 age bracket, and the cancer’s incidence rate has quadrupled in the last 30 years.
Exposure to UV light is a major risk factor for the disease. Charity Cancer Research UK suggests melanoma’s increasing incidence may be due to people going on holiday more often and the rising popularity of sun beds.
The disease is responsible for up to 80% of skin cancer deaths, according to the British Association of Dermatologists.
GSK UK general manager Erik van Snippenberg said: “Dabrafenib is the first licensed medicine of a new wave of cancer treatments currently being developed by GSK.”
He continued: “[Its authorisation] increases the therapeutic alternatives for this disease and is an important development for metastatic melanoma patients who, until recently, had very few options available”.
London-based DrugsAnalyst predicts peak annual sales of £220 million for Tafinlar as it competes with established products from Roche (Zelboraf, vemurafenib) and Bristol-Myers Squibb (Yervoy, ipilimumab).
GSK is also in the middle of two Phase III trials of Tafinlar in combination with its compound Mekinist (trametinib). Both drugs target the same type of melanoma by inhibiting the activity of different enzymes.
The first trial is comparing Tafinlar and Mekinist with Tafinlar and a placebo – GSK hopes the former combination will show greater efficacy and lead to fewer side effects.
The second trial has pitted Tafinlar and Mekinist against Zelboraf alone. Should positive results emerge for GSK, it could earn the company the lion’s share of a billion-dollar market.
Roche is conducting a similar combination study using products of its own but is several months behind its British competitor.
Hugh McCafferty
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