Another EU approval for Roche’s blockbuster Avastin

by | 28th Jan 2008 | News

Roche has received the green light for the “significantly wider use” of Avastin from regulators in Europe to treat metastatic colorectal cancer.

Roche has received the green light for the “significantly wider use” of Avastin from regulators in Europe to treat metastatic colorectal cancer.

The Swiss giant said that this new broader label will now allow Avastin (bevacizumab) to be used in combination with any chemotherapy, including Roche’s own Xeloda (capecitabine), for first and later treatment lines in patients with metastatic colorectal cancer. It added that this latest decision means that “virtually all patients with metastatic colorectal cancer now have access to Avastin’s proven survival benefits”.

The Avastin approval follows the European Committee for Medicinal Products for Human Use’s positive recommendations for the extended use of both Avastin and Xeloda in December. The final decision on the latter for its extended use is expected “imminently”, the firm added.

The news is “highly significant for the estimated 400,000 people diagnosed with metastatic colorectal cancer every year in Europe alone”, said William Burns, head of pharmaceuticals at Roche, and the decision can only boost sales of the blockbuster in the Old Continent. They may need a boost if European sales are following the same path as Avastin in the USA.

Roche’s majority-owned partner Genentech reported a 23% rise in Avastin sales to $603 million for the fourth quarter, due to increased penetration in the non-small cell lung cancer market, but this still did not satisfy analysts who had expected revenues to be in the region of $615 million. Roche will reveal details of the drug’s performance in Europe on Wednesday when it announces its full-year results.

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