FDA seeks manufacturing data for GSK’s trametinib
pharmafile | May 2, 2013 | News story | Manufacturing and Production | FDA, GSK, melanoma
GlaxoSmithKline’s melanoma drug candidate trametinib has been delayed in the US by an FDA request for more information on its manufacturing.
The US Prescription Drug User Fee Act (PDUFA) deadline for the first-in-class MEK inhibitor has been extended by three months to 3 September to accommodate the request, but GSK says it has already submitted the requested data.
GSK filed for approval of trametinib as a monotherapy for BRAF V600 mutation-positive metastatic melanoma last August along with another candidate – BRAF inhibitor dabrafenib – which together are predicted to have peak sales potential of £1.5 billion ($2.4 billion) by 2020.
Meanwhile, the European Medicines Agency (EMA) granted an accelerated six-month review to trametinib earlier this year, both as a monotherapy and in combination with dabrafenib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
The new manufacturing information submitted to FDA will also be shared with the EMA in accordance with standard centralised review processes, said GSK.
An FDA advisory panel discussed trametinib at a meeting in December, reviewing data from a number of studies, including a Phase III trial of trametinib and dabrafenib in almost 250 patients with BRAF V600-positive melanoma, which showed a marked increase in progression-free survival.
Despite the delay, GSK still looks to have a clear run at being the first company to bring a MEK inhibitor to market. Roche is probably its closest competitor, with a combination of its BRAF inhibitor Zelboraf (vemurafenib) and MEK inhibitor GADC-0973 still in Phase III testing.
Other companies developing drugs in the class include Array Biopharma/Novartis with MEK 162 and AstraZeneca with selumetinib, although the latter seems to be focusing more on lung cancer than melanoma in its development programme.
At stake is a slice of a melanoma drugs market that is forecast to expand more than seven-fold over the next decade, growing from $210 million in 2010 to $1.5 billion in 2020 in the top seven markets of the US, France, Germany, Italy, Spain, the UK and Japan – according to Decision Resources.
Near term, growth will be driven by Yervoy and Bristol-Myers Squibb’s Yervoy (ipilimumab), which had sales of $252m and $211m last year, respectively.
Phil Taylor
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