Roche and Genentech have been granted an earlier-than-expected approval in the US for Erivedge (vismodegib), the first drug specifically registered to treat basal cell carcinoma, the most common form of skin cancer.
The green light has come well ahead of the Food and Drug Administration's (FDA) March 8 deadline for reviewing the marketing application for Erivedge, which will be used in patients with locally advanced or metastatic disease who are not candidates for surgery or radiotherapy.
The new drug was fast-tracked by the FDA based on the results of the ERIVANCE BCC study, which showed that Erivedge shrank tumours or healed visible lesions in 43 per cent of patients with locally-advanced basal cell carcinoma and 30 per cent of patients with metastatic disease. The median progression-free survival for both metastatic and locally advanced patients was 9.5 months.
The approval is also a major milestone for Curis, the small biotech company which has devoted years to teasing out the metabolic pathway targeted by vismodegib.
The drug is a first-in-class oral treatment that selectively inhibits signalling in the Hedgehog pathway, which is implicated in more than 90 per cent of all basal cell cancers but found rarely in healthy tissues.
"Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases," commented Richard Pazdur, the director of the FDA's Office of Hematology and Oncology Products.
"This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly," he added.
Curis will receive a $10m milestone payment following approval, having already booked $8m from Roche when the FDA accepted vismodegib's marketing application for review. The biotech firm will also receive 5-8 per cent royalties, depending on sales levels.
In the past, Roche has predicted that vismodegib could achieve sales of more than 1bn Swiss francs at peak.
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