GlaxoSmithKline has put in supplemental applications for its Tafinlar/Mekinist combination - a pair of drugs which analysts predict may have peak sales together of £1.5 billion - to the FDA.
Both Tafinlar (dabrafenib), a BRAF inhibitor, and Mekinist (trametinib), a MEK inhibitor, are currently being looked at by regulators as a treatment for adults with unresectable or metastatic melanoma with a BRAF V600 E or K mutation.
The new applications are based a randomised Phase I/II study comparing Tafinlar on its own to the combination in patients with these mutations.
There is already an ongoing European review of Mekinist as monotherapy and as part of this combination, which was being accelerated - but the CHMP has now slowed to a standard timeframe to allow the submission to be reviewed.
In May the FDA requested more information on Mekinist’s manufacture but GSK will consider it well worth the wait if the two drugs gain approval as a two-in-one treatment.
Melanoma is certainly a prized therapy area, with analysts Decision Resources forecasting a more than seven-fold expansion over the next decade to $1.5 billion in 2020 in the top seven markets of the US, France, Germany, Italy, Spain, the UK and Japan.
Snapping at GSK’s heels is Roche, whose combination of BRAF inhibitor Zelboraf (vemurafenib) - the first drug to increase overall survival in BRAF positive melanoma patients - and MEK inhibitor GADC-0973 is in Phase III testing.
GSK is also developing a diagnostic kit for its drugs in order to assess which patients could best benefit from the new treatments, in collaboration with bioMérieux.
It has filed for FDA pre-market approval of the test which is being studied as part of the Phase III combination programme.
Other companies developing drugs in the class include Array Biopharma/Novartis with MEK 162 and AstraZeneca with selumetinib.