GSK’s Tafinlar/Mekinist combo given FDA priority review status
pharmafile | September 17, 2013 | News story | Research and Development, Sales and Marketing | GSK, Roche, Tafinlar, Zelboraf, melanoma
The FDA has granted ‘priority review’ designation to the evaluation of two GSK skin cancer drugs in combination.
Tafinlar (dabrafenib) and Mekinist (trametinib) were separately approved by regulators earlier this year for the treatment of inoperable or metastatic melanoma with BRAF protein mutations.
The combination application is based on positive results recorded in Phase I/II trials which compared Tafinlar and Mekinist treatment with Tafinlar alone.
The drugs interact with tumours in different ways. Tafinlar is a BRAF inhibitor designed to target the V600E mutation, while MEK inhibitor Mekinist tackles both the V600E and V600K mutations.
Roche’s rival product, the V600E-oriented Zelboraf (vemurafenib), already has a strong foothold in the market. The Swiss drug maker reported sales of nearly £160 million for the treatment in 2012.
However, GSK hopes its two products can together offer more robust and longer-lasting treatment for these specific forms of metastatic melanoma – of which there are around 1,000 new diagnoses every year in the UK alone.
Melanoma has a relatively high incidence rate among 15- to 34-year-olds. Diagnoses have quadrupled over the last 30 years and it is the deadliest form of skin cancer, according to the World Health Organization.
If GSK’s products prove more effective together than Roche’s treatment, it could earn the company a sizable chunk of a billion-pound market.
Roche is also conducting research into BRAF- and MEK-inhibitor combination therapy, but it appears to be playing catch-up with its British competitor.
‘Priority review’ status is an FDA mechanism designed to speed up the evaluation process for new treatments aimed at serious conditions.
The designation ensures that the regulatory body will take action on an application within six months, as opposed to the standard 10 months
Two separate decisions on the combination treatment are expected in January 2014 – one for supplementing Tafinlar with Mekinist, the other for supplementing Mekinist with Tafinlar.
This decision marks the second piece of positive regulatory news for GSK in quick succession. Last week, the FDA granted its blood cancer drug Arzerra (ofatumumab) ‘breakthrough therapy’ status.
The drug, developed in collaboration with Danish biotech company Genmab, could now be approved within six months.
Hugh McCafferty
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