FDA approves GSK cancer combo
pharmafile | January 14, 2014 | News story | Research and Development, Sales and Marketing |Â Â FDA, GSK, Tafinlar, mekinistÂ
US regulators have shown the green light to a combination of two GlaxoSmithKline skin cancer drugs, Mekinist and Tafinlar, to treat advanced melanoma.
The FDA granted the drugs priority review status in September and has now said they can be used together to treat patients with advanced melanoma, that either cannot be removed by surgery or is metastatic.
Tafinlar (dabrafenib) and Mekinist (trametinib) were separately approved by regulators earlier in 2013 for the treatment of inoperable or metastatic melanoma with BRAF protein mutations.
The combination application was based on positive results recorded in Phase I/II trials which compared Tafinlar and Mekinist treatment with Tafinlar alone.
The key to the combination is that 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.
The National Cancer Institute estimated that 76,690 Americans would be diagnosed with melanoma, and 9,480 would die from the disease in 2013.
Roche’s rival product, the V600E-oriented Zelboraf (vemurafenib), already has a strong foothold in the market. The Swiss drugmaker 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 – which 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 Organisation.
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 – indeed, analysts have predicted peak annual sales for Mekinist and Tafinlar to reach £1.5 billion ($2.4 billion) by 2020.
Two Phase III trials – COMBI-d and COMBI-v – are also looking at the combinations.
COMBI-d will combine the drugs in patients with BRAF V600E or V600K mutation-positive metastatic cutaneous melanoma, to see whether they are better than Tafinlar alone in stopping or slowing the progression of metastatic melanoma.
The second study will combine GSK’s drugs and pit them against Zelboraf.
Roche is also conducting research into BRAF- and MEK-inhibitor combination therapy.
Adam Hill
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