Taxotere Breast Cancer Drug Withdrawn From EMEA Consideration

Armen Hareyan's picture

It looks like French pharma company, sanofi-aventis, has decided to withdraw an application to the EU regulators to extend the indications on the cancer drug Taxotere and its generic version, Docetaxel Winthrop.

The European Medicines Agency (EMEA) announced in a press release earlier this week that it has been formally notified by sanofi-aventis that the application to use the two drugs for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2 has been pulled.  They were originally 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 cancer (NSCLC) and prostate carcinoma, as well as gastric adenocarcinoma and head and neck cancer.

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 on the grounds that the study design did not adequately define the contribution of Taxotere and Docetaxel Winthrop.  Sanofi then requested a re-examination of the opinion, which was under review by the Committee for Medicinal Products for human use (CHMP) at the time of the withdrawal.

More information will likely be available at a later date when the EMEA publishes a Q&A document on it's website.  sanofi-aventis has not yet made any formal statement on the EU withdrawal in its online press room.