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Thursday 19 October 2006

Committee for Medicinal Products for Human Use Post-authorisation Summary of Positive Opinion for Hycamtin

By: PharmaLive

On 18 October 2006 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion to recommend the variation to the terms of the marketing authorisation for the medicinal product Hycamtin. The Marketing Authorisation Holder for this medicinal product is SmithKline Beecham Plc.

The new indication adopted by CHMP is: "treatment, in combination with cisplatin, of patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination".

Detailed conditions for the use of this product will be described in the updated Summary of Product Characteristics (SPC) which will be published in the revised European Public Assessment Report (EPAR) and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.

For information, the full indication of Hycamtin will be as follows***:

"Topotecan monotherapy is indicated for the treatment of:

* patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.

* patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).

Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1)."

* Summaries of positive opinion are published without prejudice to the Commission Decision, which will normally be issued within 44 days (Type II variations) and 67 days (Annex II applications) from adoption of the Opinion.

** Marketing Authorisation Holders may request a re-examination of any CHMP opinion, provided they notify the EMEA in writing of their intention to request a re-examination within 15 days of receipt of the opinion.

*** The text in bold represents the new or the amended indication.

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