Sanofi-Aventis has been given the green light by the European Commission for two new indications for Taxotere (docetaxel), its big-selling cancer drug.

Taxotere – Sanofi-Aventis’ fourth-biggest drug with sales of 1.08 billion euros in the first nine months of 2004 – is already approved for metastatic breast cancer, non-small cell lung cancer and latterly prostate tumours [[04/11/04d]], but the label extension is significant as it boosts the competitive strength of the drug’s label. The first approval is for Taxotere’s use, in combination with doxorubicin and cyclophosphamide, for the adjuvant treatment of patients with operable node-positive breast cancer, while the second clears it for use in combination with Roche/Genentech’s Herceptin (trastuzumab) for patients with metastatic breast cancer whose tumours over-express the Her2 gene.

Sanofi-Aventis said that Taxotere is the only drug in its class proven to improve survival in women with operable node-positive breast cancer, which could give it an advantage over rival treatment paclitaxel, sold generically and as Taxol by Bristol-Myers Squibb. Approval for use with Herceptin also shores up its competitive position versus paclitaxel as the latter drug is already approved for this indication.