GlaxoSmithKline (GSK) has withdrawn its bid to have a new personalised combination treatment regimen for skin cancer approved in the EU.
The pharma company announced that it will no longer go through with its initial marketing application for the use of Mekinist (trametinib) in combination with the already approved BRAF inhibitor Tafinlar (dabrafenib) for the treatment of adult patients with advanced melanoma who have a BRAF V600 genetic mutation.
The decision is based on discussions with the European Medicines Agency (EMA) that have indicated the data provided by GSK is not suitable to ‘conclude on a positive benefit-risk balance of the combination’.
This data was from a phase II study submitted to the EMA in 2012, which aimed to compare the safety and efficacy of the combination to treatment with Tafinlar alone in melanoma patients.
GSK said it will resubmit the marketing application once more data from its ongoing phase III programme is available. This also includes an additional study comparing the combination of Mekinist and Tafinlar to Tafinlar and placebo.
Dr Rafael Amado, head of oncology R&D at GSK, said: “Although we have withdrawn our application, we remain committed to providing further data from our ongoing phase III development programme to support a subsequent re-submission in Europe.”
Mekinist is also under review by the EMA as a treatment in its own right and a recommendation is expected in the next few months.
The situation for the combination treatment contrasts with GSK’s fortunes in the US, where Mekinist and Tafinlar were approved for use together at the beginning of the year.
The FDA approval, which was hastened via an accelerate approval programme under a priority review designation, has allowed GSK to increase its presence in the growing market for personalise melanoma treatments.
This has been led by Bristol-Myers Squibb’s Yervoy, which is tipped to reach $2bn at peak, while Roche reported Zelboraf revenues of about $286m for the first nine months of 2013.