April 15, 2011 / 11:19 AM / 9 years ago

UPDATE 2-EU body relaxes curb on Avastin breast cancer use

* EMA says Roche drug can be used with Xeloda

* Follows re-examination of previous negative opinion

(Adds Roche reaction, background)

LONDON, April 15 (Reuters) - European regulators said on Friday they were relaxing curbs on the use of Roche’s ROG.VX top-selling cancer drug Avastin to allow its use with Xeloda, another type of chemotherapy that is also made by Roche.

The decision is good news for the Swiss drugmaker, which has been hit by plans to restrict use of Avastin in breast cancer on both sides of the Atlantic.

European Medicines Agency experts are now recommending that Avastin can be used as a first-line treatment in combination with Xeloda, or capecitabine, in patients with metastatic breast cancer for whom other options are not appropriate.

The move follows a re-examination of a previous negative opinion.

Back in December, the agency had ruled that Avastin should only be used to treat advanced breast cancer with paclitaxel — not with Xeloda or docetaxel.

Roche welcomed the move and said the ability to give Avastin with paclitaxel or Xeloda would offer more choice to physicians and patients. Although adding Avastin to paclitaxel is common in Europe, such taxane-based chemotherapy is not suitable for all patients.

Final approval from the European Commission for the new use is expected later this year.

Sales of Avastin fell in the first quarter of 2011 on the back of last year’s decision by U.S. and European regulators to limit its use in breast cancer. As a result, Rituxan replaced Avastin as Roche’s top-seller in the period. [ID:nLDE73D03H]

Roche has already cut its peak sales forecast for Avastin, which had sales of 6.5 billion francs in 2010, to around 7 billion francs after U.S. authorities proposed revoking approval of the drug to treat breast cancer. [ID:nLDE710163] (Reporting by Ben Hirschler; editing by Paul Sandle and Mark Potter)

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