Sanofi-Aventis has decided to withdraw an application to regulators in Europe to extend the indications on the cancer drug Taxotere and its generic version Docetaxel Winthrop.

The European Medicines Agency says it has been formally notified by the French drugmaker that it has pulled an application to use the two drugs for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2. It was planned to be used in combination with Herceptin (trastuzumab) following a chemotherapy regimen based on doxorubicin and cyclophosphamide and in combination with trastuzumab and carboplatin.

Taxotere and Docetaxel Winthrop are currently indicated for the treatment of breast, non-small cell lung and prostate cancers, as well as gastric adenocarcinoma and head and neck cancer. However, in July, the EMEA’s Committee for Medicinal Products for Human Use adopted a negative opinion and recommended the refusal of the extension of indication for the medicines.

Sanofi then requested a re-examination of the opinion, which was under review by the CHMP at the time of the withdrawal, which is based on the the latter body’s view that the study design did not adequately define the contribution of Taxotere and Docetaxel Winthrop.

The EMEA also announced that France’s Novagali Pharma has withdrawn its application to market Vekacia (ciclosporin) for the treatment of vernal keratoconjunctivitis after the CHMP said that the data provided did not allow it “to conclude on a positive benefit-risk balance”.

Also, Unigene’s UK unit has voluntarily withdrawn its marketing authorisation for Forcaltonin (recombinant salmon calcitonin) for the prevention of acute bone loss, citing commercial reasons.