EMA Adopts Positive Opinion for Docetaxel Kabi
15 March 2012
Committee for medicinal products for human use (CHMP)
Summary of opinion 1 (initial authorisation)
On 15 March 2012 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive
opinion, recommending the granting of a marketing authorisation for the medicinal product Docetaxel
Kabi 20 mg/ml concentrate for solution for infusion intended for the treatment of breast cancer, non-
small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer.
The applicant for this medicinal product is Fresenius Kabi Oncology Plc. They may request a re-
examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of
their intention within 15 days of receipt of the opinion.
The active substance of Docetaxel Kabi is docetaxel, an antineoplastic medicinal product (L01CD 02)
that disrupts intracellular structures necessary for the replication and survival of cells (cytotoxic
Docetaxel Kabi is a generic of Taxotere, which has been authorised in the EU since 27 November 1995.
Studies have demonstrated the satisfactory quality of Docetaxel Kabi. A bioequivalence study versus
the reference product Taxotere was not required. A question and answer document on generic
medicines can be found here.
A pharmacovigilance plan for Docetaxel Kabi will be implemented as part of the marketing
The approved indications are:
Docetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant
treatment of patients with:
? operable node-positive breast cancer
? operable node-negative breast cancer
Summaries of positive opinion are published without prejudice to the commission decision, which will normally be issued
67 days from adoption of the opinion.
EMA/CHMP/56643/2012 Page 2/2
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 (see section 5.1).
Docetaxel Kabi in combination with doxorubicin is indicated for the treatment of patients with locally
advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this
Docetaxel Kabi monotherapy is 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.
Docetaxel Kabi in combination with trastuzumab is indicated for the treatment of patients with
metastatic breast cancer whose tumours over express HER2 and who previously have not received
chemotherapy for metastatic disease.
Docetaxel Kabi in combination with capecitabine is 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
Docetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic non-small
cell lung cancer after failure of prior chemotherapy.
Docetaxel Kabi in combination with cisplatin is 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.
Docetaxel Kabi in combination with prednisone or prednisolone is indicated for the treatment of
patients with hormone refractory metastatic prostate cancer.
Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is 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
Docetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment
of patients with locally advanced squamous cell carcinoma of the head and neck.
It is proposed that Docetaxel Kabi should only be administered under the supervision of a physician
qualified in the use of anticancer chemotherapy.
Detailed recommendations for the use of this product will be described in the summary of product
characteristics (SmPC), which will be published in the European public assessment report (EPAR), and
will be available in all official European Union languages after the marketing authorisation has been
granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a
favourable benefit to risk balance for Docetaxel Kabi and therefore recommends the granting of the
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© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.
Posted: March 2012