Roche’s skin cancer drug Eviredge, developed in collaboration with Curis, has been approved by the US Food and Drug Administration.
The drug is used to treat basal cell carcinoma (BCC) and comes in a once-a-day pill formulation, with the approval coming on the back of a six month review based on results from a Phase II study that showed Eviredge shrank lesions in 27 out of 63 patients with locally advanced BCC, and ten out of 33 patients with metastatic BCC.
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Everidge becomes Roche’s second skin cancer drug to be approved by the FDA, following in the footsteps of Zelboraf, used to treat melanoma, which received approval in August 2011.
Produced by Genentech, a unit of Roche, the pill is scheduled to be available within one to two weeks and will cost $7,500 per month, with an expected treatment time per patient of around ten months.
The drug, the first BCC treatment to receive FDA approval, comes with a warning regarding the potential risk of death or severe birth defects to unborn children.
Curis will receive a $10m payment as a result of the approval, with the company also set to receive royalties relating to sales of the drug.
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By GlobalData
