EMA Adopts Positive Opinion for Docetaxel Kabi
15 March 2012
EMA/CHMP/56643/2012
Committee for medicinal products for human use (CHMP)
Summary of opinion 1 (initial authorisation)
Docetaxel Kabi
docetaxel
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
activity).
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
authorisation.
The approved indications are:
Breast cancer
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
1
Summaries of positive opinion are published without prejudice
to the commission decision, which will normally be issued
67 days from adoption of the opinion.
Docetaxel Kabi
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
condition.
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.
Prostate cancer
Docetaxel Kabi in combination with prednisone or prednisolone is
indicated for the treatment of
patients with hormone refractory metastatic prostate cancer.
Gastric adenocarcinoma
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
marketing authorisation.
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© European Medicines Agency, 2012. Reproduction is authorised
provided the source is acknowledged.
Posted: March 2012
