Roche aims for wholly personalised skin cancer drug
pharmafile | May 12, 2011 | News story | Sales and Marketing | Roche, personalised medicine, skin cancer, vemurafenib
Roche has submitted its key skin cancer drug vemurafenib to European and American regulators for approval.
Vemurafenib (formerly RG7204) has consistently impressed in late-stage trials and has been the first drug of its kind to increase overall survival in metastatic melanoma patients who over express the V600 mutation.
At the same time Roche has also submitted an application for the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic for the drug.
The oncology specialist is attempting to create a wholly personalised therapy for the disease, and producing a diagnostic kit for the drug may help it pass through regulatory hurdles more easily.
Hal Barron, head of global product development at Roche, said: “We have worked swiftly to advance the vemurafenib development programme knowing that patients with metastatic melanoma have a poor prognosis and limited treatment options.
“The regulatory submissions of vemurafenib and the companion diagnostic to identify people with the type of melanoma specifically targeted by this medicine are exciting steps toward our goal of delivering a personalised therapy for this disease.”
The drug is being co-developed with US biotech firm Plexxikon and analysts at Jefferies International have suggested it has blockbuster potential, given that skin cancer is such a difficult to treat disease with few treatment options.
Roche is also considering a broad development programme with vemurafenib that may include combinations with other medicines (both approved and investigational, from Roche and other companies), as well as studies in other tumour types.
There are a number of new skin cancer treatments on the horizon and two months Bristol-Myers Squibb stole a march over Roche when it received an FDA approval for Yervoy (ipilimumab).
Yervoy has been approved as a first and second line treatment for advanced, inoperable or metastatic melanoma, the deadliest and most aggressive form of skin cancer.
Analysts forecasts for the drug range from $820 million (£513 million) to $1.7 billion by 2015.
But the drug has received a black box warning from the FDA because of a high number of serious adverse events seen in clinical trials.
Ben Adams
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