GSK submits melanoma drugs for regulatory approval
pharmafile | August 3, 2012 | News story | Sales and Marketing | FDA, GSK, NDA, Zelboraf, melanoma, oncology
GlaxoSmithKline has submitted its two investigational melanoma drugs to regulators in both Europe and the US.
The firm is seeking approval of its BRAF inhibitor dabrafenib and MEK inhibitor trametinib, to treat patients with BRAF V600 mutation positive metastatic melanoma.
It is specifically looking for market authorisation from the European Medicines Agency for dabrafenib, for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
It is also sending a New Drug Application (NDA) to the FDA for dabrafenib and trametinib to treat patients with unresectable or metastatic melanoma with BRAF V600 mutation, as detected by an FDA-approved test.
Analysts predict blockbuster sales if these drugs gain approval, with combined peak annual sales estimated to reach £1.5 billion ($2.4 billion) by 2020.
GSK is also developing a diagnostic kit for its drugs in order to assess which patients could best benefit from the new treatments.
GSK has collaboration with bioMérieux to develop the kit – the company has filed for FDA pre-market approval of the test and it is currently being studied in the Phase III trametinib-dabrafenib combination programme.
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.
Both of these drugs have been approved in the past year; Zelboraf brought in CHF 93 million ($94.8 million) for the first half of 2012 whilst Yervoy saw sales of $316 million.
Dr Rafael Amado, head of oncology R&D at GSK, said: “These regulatory submissions represent important progress in our Oncology pipeline.”
He added that his company would submit an application to the European Medicines Agency for trametinib in BRAF V600 mutation positive metastatic melanoma ‘in the coming months’.
Ben Adams
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