Hycamtin

topotecan

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This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Hycamtin?

Hycamtin is a cancer medicine that contains the active substance topotecan. It is available as a powder to be made up into a solution for infusion (drip) into a vein and as capsules (0.25 and 1 mg).

What is Hycamtin used for?

Hycamtin is used on its own to treat patients with:

  • metastatic cancer of the ovary (when the cancer has spread to other parts of the body). It is used after at least one other treatment has failed;
  • small cell lung cancer, when the cancer has relapsed (come back). It is used when giving the original treatment again is not recommended.

It is also used together with cisplatin (another cancer medicine) to treat women with cancer of the cervix, when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (has spread beyond the cervix).

The medicine can only be obtained with a prescription.

How is Hycamtin used?

Treatment with Hycamtin should only be given under the supervision of a doctor experienced in the use of chemotherapy. Infusions should be carried out in a specialised cancer ward.

The dose of Hycamtin to be used depends on the type of cancer that it is being used to treat and the patient’s weight and height. When Hycamtin is used on its own for ovarian cancer, it is given by intravenous infusion over 30 minutes. For lung cancer, Hycamtin can be given as an infusion or, for adults, as capsules. For both ovarian and lung cancer, Hycamtin is given every day for five days with a three-week interval between the start of each course. Treatment may continue until the disease gets worse.

When used with cisplatin in cervical cancer, Hycamtin is given as an infusion on days 1, 2 and 3 (with cisplatin given on day 1). This is repeated every 21 days for six courses or until the disease gets worse.

Doses of Hycamtin may need to be adjusted or treatment delayed, depending on side effects. For full details, see the summary of product characteristics, also part of the EPAR.

How does Hycamtin work?

The active substance in Hycamtin, topotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors’. It blocks an enzyme called topoisomerase I, which is involved in the division of DNA. When the enzyme is blocked, the DNA strands break. This prevents the cancer cells from dividing and they eventually die. Hycamtin also affects non‑cancer cells, which causes side effects.

How has Hycamtin been studied?

Hycamtin as an infusion has been studied in more than 480 women with ovarian cancer who had failed one treatment with platinum-containing cancer medicines. Three studies were ‘open’, meaning that the medicine was not compared to any other treatment and the patients knew that they were receiving Hycamtin. The fourth study involved 226 women, and compared Hycamtin with paclitaxel (another cancer medicine). The main measure of effectiveness was the number of patients whose tumours responded to treatment.

Hycamtin has also been studied in three main studies in 656 patients with relapsed small cell lung cancer. One study compared Hycamtin capsules with symptom control alone and another compared Hycamtin as an infusion with cyclophosphamide, doxorubicin and vincristine (a standard combination of chemotherapy). The third study compared Hycamtin given as an infusion and as capsules. The effectiveness was measured by looking at survival or response rates.

Hycamtin as an infusion has been studied in 293 women with advanced cervical cancer, where the effectiveness of a combination of Hycamtin and cisplatin was compared with that of cisplatin alone. The effectiveness was measured by looking at overall survival.

What benefit has Hycamtin shown during the studies?

ut 16%. In the main study, 21% of the patients who received Hycamtin (23 out of 112) responded to treatment, compared with 14% of the paclitaxel patients (16 out of 114).

In lung cancer, looking at the results obtained in all three studies, the response rate was 20% (480 patients received Hycamtin). Compared with symptom control alone, Hycamtin prolonged survival by 12 weeks. It was as effective as the standard combination chemotherapy. Hycamtin given as capsules was as effective as Hycamtin given as an infusion.

In cervical cancer, patients receiving the combination of Hycamtin and cisplatin survived an average of 9.4 months, compared with 6.5 months for the patients who received cisplatin only.

What is the risk associated with Hycamtin?

The most common side effects with Hycamtin (seen in more than 1 patient in 10) are neutropenia (low white blood cell counts), febrile neutropenia (neutropenia with fever), thrombocytopenia (low platelet counts), anaemia (low red blood cell counts), leucopenia (low white blood cell counts), nausea (feeling sick), vomiting and diarrhoea (all of which may be severe), constipation, abdominal (tummy) pain, mucositis (mouth sores), alopecia (hair loss), loss of appetite (which may be severe), infections, pyrexia (fever), asthenia (weakness) and fatigue (tiredness).

Hycamtin must not be used in patients who are breast-feeding, or in patients who have severe bone marrow depression (low white blood cell and platelet counts) before treatment. For the full list of all side effects and restrictions with Hycamtin, see the package leaflet.

Why has Hycamtin been approved?

The CHMP decided that Hycamtin’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Hycamtin?

A risk management plan has been developed to ensure that Hycamtin is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Hycamtin, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Hycamtin

The European Commission granted a marketing authorisation valid throughout the European Union for Hycamtin on 12 November 1996.

For more information about treatment with Hycamtin read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Hycamtin : EPAR - Summary for the public BG = bălgarski 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public ES = español 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public CS = čeština 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public DA = dansk 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public DE = Deutsch 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public ET = eesti keel 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public EL = elliniká 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public EN = English 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public FR = français 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public IT = italiano 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public LV = latviešu valoda 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public LT = lietuvių kalba 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public HU = magyar 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public MT = Malti 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public NL = Nederlands 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public PL = polski 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public PT = português 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public RO = română 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public SK = slovenčina 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public SL = slovenščina 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public FI = suomi 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public SV = svenska 2009-08-07 2015-06-26
Hycamtin : EPAR - Summary for the public HR = Hrvatski 2009-08-07 2015-06-26

This EPAR was last updated on 03/10/2016 .

Authorisation details

Product details

Product details for Hycamtin
NameHycamtin
Agency product numberEMEA/H/C/000123
Active substance

topotecan

International non-proprietary name (INN) or common name

topotecan

Therapeutic area Small Cell Lung CarcinomaUterine Cervical NeoplasmsOvarian Neoplasms
Anatomical therapeutic chemical (ATC) code L01XX17

Publication details

Publication details for Hycamtin
Marketing-authorisation holder

Novartis Europharm Limited

Revision26
Date of issue of marketing authorisation valid throughout the European Union12/11/1996

Contact address:

Novartis Europharm Limited
Frimley Business Park
Camberley GU16 7SR
United Kingdom

Product information

Product information

26/07/2016  Hycamtin -EMEA/H/C/000123 -N/0072

Name Language First published Last updated
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03
Hycamtin : EPAR - Product Information HR = Hrvatski 2009-05-12 2016-10-03

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  
Hycamtin : EPAR - All Authorised presentations HR = Hrvatski 2008-05-08  

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.

Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Hycamtin : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-02-19  
Hycamtin : EPAR - Scientific Discussion HR = Hrvatski 2006-02-19  

Authorised

This medicine is approved for use in the European Union