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CHMP recommends early use of Roche's Herceptin

EMA advisors recommend breast cancer treatment's use at an earlier stage on the condition’s progression

Roche's Herceptin (trastuzumab) has been recommended for a license extension in Europe that would see the breast cancer drug used at an earlier stage of the condition's progression.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) backed the drug's use to treat patients with HER2 positive early breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy.

It is recommended for locally advanced form of the disease or in patients with tumours that are larger than 2cm in diameter.

CHMP recommendations are usually followed by full European approval within three months.

Herceptin is already approved in Europe for HER2 breast cancer that has spread to other parts of the body.

Herceptin works by regulating the body's production levels of HER2, a protein that can increase the aggressiveness of breast cancers leading to increased disease reoccurrence and worse disease outcomes.

The EMA said detailed conditions for the use of this Herceptin will published in the revised European public assessment report (EPAR) once marketing authorisation has been granted by the European Commission.

The drug made 3.91bn Swiss francs for the first nine months of 2011, making it Roche's third biggest selling pharmaceutical product.

The EMA's recommendation for Herceptin comes as the US Food and Drug Administration (FDA) revoked approval for another Roche cancer treatment, Avastin (bevacizumab).

The US regulator's decision is based on the grounds that Avastin's benefits in breast cancer are modest and outweighed by its side effects, but the drug will remain on the market for other indications, including colon, lung and kidney cancer and glioblastoma, a form of brain tumour.

Currently, Avastin is still approved in Europe when used in combination with paclitaxel in breast cancer patients, although it recommended against its use alongside docetaxel and capecitabine.

21st November 2011


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