EMA Recommends Extension of Indications for Taxotere and Docetaxel Zentiva

New indication concerns the treatment of patients with metastatic hormone-sensitive prostate cancer in combination with androgen-deprivation therapy, with or without prednisone or prednisolone

On 19 September 2019, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal products Taxotere (docetaxel) and Docetaxel Zentiva.

The marketing authorisation holder for Taxotere is Aventis Pharma S.A.

The marketing authorisation holder for Docetaxel Zentiva is Zentiva, k.s..

The CHMP adopted an extension to an existing indication for both drugs as follows (new text in bold):

TAXOTERE or Docetaxel Zentiva in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, are indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer.

For information, the full indications for Taxotere and Docetaxel Zentiva will be as follows:

Breast cancer

TAXOTERE or Docetaxel Zentiva in combination with doxorubicin and cyclophosphamide are indicated for the adjuvant treatment of patients with:

  • operable node positive breast cancer
  • operable node-negative breast cancer

For patients with operable node negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.

TAXOTERE or Docetaxel Zentiva in combination with doxorubicin are indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.

TAXOTERE or Docetaxel Zentiva monotherapy are indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.

TAXOTERE or Docetaxel Zentiva in combination with trastuzumab are indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.

TAXOTERE or Docetaxel Zentiva in combination with capecitabine are indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.

Non-small cell lung cancer

TAXOTERE or Docetaxel Zentiva are indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.

TAXOTERE or Docetaxel Zentiva in combination with cisplatin are indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.

Prostate cancer

TAXOTERE or Docetaxel Zentiva in combination with prednisone or prednisolone are indicated for the treatment of patients with metastatic castration-resistant prostate cancer.

TAXOTERE or Docetaxel Zentiva in combination with ADT, with or without prednisone or prednisolone, are indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer.

Gastric adenocarcinoma

TAXOTERE or Docetaxel Zentiva in combination with cisplatin and 5-fluorouracil are indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.

Head and neck cancer

TAXOTERE or Docetaxel Zentiva in combination with cisplatin and 5 fluorouracil are indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

Detailed recommendations for the use of these products will be described in the updated summary of product characteristics, which will be published in the revised European public assessment reports, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.