Roche’s Erivedge gains conditional EU approval
pharmafile | July 15, 2013 | News story | Sales and Marketing | Curis, EU, Erivedge, Roche, Swiss, Zelboraf
Roche’s cancer pill Erivedge has received a conditional European approval for treatment of the most common type of skin cancer.
The European Commission has granted approval to Erivedge (vismodegib) for the treatment of adult patients with symptomatic metastatic basal cell carcinoma or locally advanced BCC inappropriate for surgery or radiotherapy.
This approval makes Erivedge, a capsule taken once-a-day, the first licensed medicine for patients in the European Union with this disfiguring and potentially life-threatening form of skin cancer.
But the treatment, which Roche co-develops with Curis, has been approved under the condition that Roche provides additional data on Erivedge from an ongoing global safety study.
The EC usually gives a conditional marketing authorisation to drugs with a positive benefit/risk assessment that satisfy an unmet medical need, and whose availability would result in a significant public health benefit.
The EC’s decision is based on data from Roche’s 2010 ERIVANCE Phase II study, which showed that serious adverse events (SAEs) were observed in 25% of studied patients.
Roche says, however, that of these only 4% of patients had SAEs that were considered to be related to treatment with Erivedge.
This included one case each of: blocked bile flow from the liver (cholestasis), dehydration with loss of consciousness (syncope), pneumonia accompanied by an inability of the heart to pump enough blood (cardiac failure) and a sudden arterial blockage in the lung (pulmonary embolism).
It is these SAEs that have worried the Commission enough to warrant more safety data from the drug, but not enough to bar it from European patients.
“Today’s approval is great news for patients with advanced basal cell carcinoma, who previously had no medicines to treat their disease,” said Hal Barron Roche’s chief medical officer.
“Erivedge substantially reduced tumour size in patients in clinical trials, and we are pleased that Erivedge will now be available to patients in the European Union.”
The safety profile of Erivedge is being assessed in STEVIE, a global, single-arm, open-label multicentre study of 1,200 patients with advanced forms of basal cell carcinoma.
An interim analysis from STEVIE presented at ASCO 2013 confirmed a similar safety profile to that observed in the ERIVANCE BCC study.
Most common, but least deadly
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.
Melanoma is the most dangerous type of skin cancer – Roche gained US approval for Zelboraf in 2011 to treat advanced melanoma.
In January 2012, Erivedge became the first licensed medicine for patients with advanced BCC in the US when the FDA approved it under the priority review.
Erivedge is a Hedgehog Pathway Inhibitor, a cancer medicine designed to selectively target and block abnormal activity in a cell growth pathway, known as the Hedgehog signalling pathway, which helps to regulate growth and development in the early stages of life.
The Hedgehog pathway usually becomes less active as a person matures. However, mutations may reactivate the pathway, causing it to work incorrectly. These mutations are thought to occur in 90% of cases of BCC.
Ben Adams
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