The European Medicines Agency has given GlaxoSmithKline’s melanoma drug an accelerated review.
The drug – a MEK inhibitor called trametinib – is seeking a European licence as both a monotherapy and in combination with GSK’s investigational BRAF inhibitor dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has granted GSK’s request for accelerated assessment of this application, meaning it may be on the market within six months if approved.
The application includes data from a Phase III study of trametinib monotherapy compared to the established chemotherapy agents dacarbazine or paclitaxel monotherapy in patients with BRAF V600 mutation positive metastatic melanoma
It also includes data from a randomised Phase I/II study comparing dabrafenib monotherapy to combination therapy with dabrafenib and trametinib in patients with BRAF V600 mutation positive metastatic melanoma
“We initiated a randomised study very early in the development programme to test whether the novel-novel combination could circumvent resistance to single agent anti-BRAF therapy and are encouraged by the results from this Phase I/II trial,” said Dr Rafael Amado, head of oncology R&D at GSK.
“We are planning further regulatory submissions based on these data, in the US and other countries in the coming months,” he added.
An application that has been granted accelerated assessment will have a maximum review time of 150 days, although the CHMP can extend this if needs be.
GSK hoping to enter the melanoma market
In August 2012, GSK announced regulatory submissions for dabrafenib monotherapy as a treatment for BRAF V600 metastatic melanoma in Europe and the USA, as well as a US submission for trametinib monotherapy as a treatment for BRAF V600 metastatic melanoma.
Trametinib and dabrafenib are investigational medicines and their use as monotherapy or combination therapy is not approved anywhere in the world.
Roche’s Zelboraf (vemurafenib) is currently the only licensed drug to treat BRAF positive melanoma patients, and is the first drug to increase overall survival in this patient population.
GSK is currently conducting a head-head Phase III trial against Zelboraf, with both of its drugs, results of which are expected next year. If approved GSK’s drugs will also be up against Bristol-Myers Squibb’s vaccine Yervoy, which works as a cancer vaccine.
Yervoy and Zelboraf are both expected to bring in peak annual sales of around $1 - $2 billion, making the new melanoma market a potentially lucrative venture for pharma.