USA: Roche will try to maintain the approval of Avastin

Written by Sandeep Nehra

The Swiss pharmaceutical group Roche has requested a hearing before the U.S. authorities to try to keep the U.S. approval of its drug Avastin for the treatment of a specific type of breast cancer.

Roche asked the hearing through its subsidiary Genentech, but the request has not yet been accepted by the U.S. Federal Drug Agency (FDA) said the Swiss laboratory in a statement.

This request for hearing comes as the FDA proposed to withdraw approval of Avastin in combination with paclitaxel chemotherapy for first line treatment of HER2-negative advanced stage.

In July, an FDA panel had recommended not to use Avastin in this indication. A decision on this matter, scheduled for September 17, had been postponed by three months.

By the end of this procedure, Avastin is approved in the United States, “said Roche.

The European Medicines Agency (EMA) has announced in a statement that Avastin in combination with paclitaxel was still approved, but only in this combination.

The use of this drug with docetaxel product however was considered “negative” by the Committee for Medicinal Products for Human Use (CHMP) of the European Union, which recommends not to use this combination to treat breast cancer.

At the Swiss Exchange, the title of Roche retreated 1.13% to 139.60 Swiss francs in a market virtually unchanged (-0.02%) at 16.25 GMT.

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