Roche’s skin cancer drug receives FDA priority review
pharmafile | November 9, 2011 | News story | Research and Development, Sales and Marketing | Roche, vismodegib
Roche’s skin cancer pill vismodegib will receive a priority review from the FDA which could see it approved within six months.
The drug is targeted to treat advanced basal cell carcinoma in patients for whom surgery is inappropriate.
The treatment has only undergone Phase II studies but the FDA has accepted its submission based on the strength of these results.
In the Phase II ERIVANCE BCC study, vismodegib substantially shrank tumours or healed visible lesions in 43% of patients with locally advanced BCC, and 30% of patients with metastatic BCC.
Priority status is given to drugs that are either highly innovative, or those that provide treatment for an unmet medical need and thus speed up the regulatory process.
The FDA said an action date for the drug is 8 March 2012, meaning it could be on the market in less than six months. Roche is looking for approval in Europe for next year.
It is developing vismodegib under a collaboration agreement with US biotech Curis, which is eligible to receive up to $115 million in cash and milestone payments based on the drug’s performance.
If approved following the review it would be the second successful skin cancer treatment from Roche to be approved by the FDA.
Earlier this year the US regulator approved the firm’s advanced melanoma drug Zelboraf, which is estimated to bring around $700 million in peak annual sales.
Basal cell carcinoma is the most common form of skin cancer, but the least deadly, with only 1% of all cases metastasising due to it being a slow growing tumour.
But when the disease does advance, BCC can cause disfiguring and debilitating effects. Currently, there are no effective treatment options for advanced BCC.
Vismodegib is designed to selectively inhibit signalling in the Hedgehog pathway, which is implicated in more than 90% of BCC cases.
Around 900,000 people are diagnosed with BCC every year and the incidence is rising, meaning any treatment will be highly lucrative.
Ben Adams
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