Roche’s Erivedge gains FDA approval
pharmafile | January 31, 2012 | News story | Sales and Marketing | Erivedge, FDA, Roche
The FDA has approved Roche’s Erivedge to treat patients with a common form of skin cancer.
Erivedge (vismodegib) is now licensed to treat advanced or metastatic basal cell carcinoma that has recurred following surgery, or who are not candidates for either surgery or for radiation.
Erivedge is a pill taken once a day and has a novel mechanism of action that inhibits the Hedgehog pathway, which is active in most basal cell cancers.
This pathway plays an important role in regulating proper growth and development in the early stages of life and becomes less active in adults – abnormal signalling is implicated in more than 90% of BCC cases.
It’s currently the focus of research for a number of big pharma firms, with Pfizer, Bristol-Myers Squibb and Novartis developing drugs in this category.
This is the first drug to be approved for this type of skin cancer in the US, and will cost $7,500 a month, with the total course of treatment expected to average $75,000.
Roche said that its drug would be available in the US ‘within one to two weeks’. The firm added that it has also submitted a marketing authorisation for Erivedge in Europe.
Erivedge will come with a Black Box safety warning that alerts patients of the potential risk of death or severe birth effects to a foetus.
Most common, but least deadly skin cancer
There are three types of skin cancer: basal cell carcinoma, squamous cell carcinoma and melanoma.
BCC is the least dangerous of the three with only 2% of all cases metastasising, but it is the most common skin cancer in the US, affecting around two million Americans in 2010.
The disease is considered curable if the cancer is restricted to a small area of the skin, but in the rare cases of advanced BCC, the disease often results in severe deformity or loss of function of affected organs.
The safety and effectiveness of Erivedge was shown in single study of 96 patients with locally advanced or metastatic basal cell carcinoma.
The study’s primary endpoint was objective response rate, or the percentage of patients who experienced complete and partial shrinkage or disappearance of the cancerous lesions after treatment.
Of the patients with metastatic disease receiving Erivedge, 30% experienced a partial response, and 43% of patients with locally advanced disease experienced a complete or partial response.
Speedy approval
The regulator said it had approved the drug ahead of its 8 March deadline as it aims to treat an unmet medical need.
Richard Pazdur, director of the office of haematology and oncology at the FDA, said: “Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases.
“This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly. This is important for patients who will have access to more effective therapies with potentially fewer side effects.”
Melanoma is the most dangerous type of skin cancer – Roche gained US approval for Zelboraf last year to treat advanced melanoma.
Hal Barron, head of global product development, said: “We are pleased that in the last six months we have been able to provide two new medicines for different types of advanced skin cancer to people who previously had few or no treatment options.”
Ben Adams
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