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 of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Cancidas?

Cancidas is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance caspofungin.

What is Cancidas used for?

Cancidas is an antifungal medicine. It is used to treat adults, adolescents and children with:

• invasive candidiasis (a type of fungal infection due to Candida);
• invasive aspergillosis (another type of fungal infection due to Aspergillus) when the patient does not respond to or does not tolerate amphotericin B or itraconazole (other antifungal medicines);
• suspected fungal infections (such as due to Candida or Aspergillus) when the patient is febrile (feverish) and neutropenic (lacking white blood cells). This is known as ‘empirical treatment’, which means that the treatment is started based on an observation of the patient before the doctor has a confirmation of the infection.

The medicine can only be obtained with a prescription.

How is Cancidas used?

Cancidas treatment should be started by a doctor who has experience in the management of invasive fungal infections. Cancidas must be made up into a solution before use, using a diluent that does not contain glucose.

It is given once a day by slow infusion lasting about one hour. In adults, treatment starts with a 70 mg loading dose, followed by a daily 50 mg dose, or 70 mg if the patient weighs more than 80 kg. A lower dose may be necessary in adults who have moderate problems with their liver.

In patients between 12 months and 17 years of age, the dose depends on body surface area (calculated using the child’s height and weight). Cancidas should be used with caution in children below 12 months of age, because it has not been studied sufficiently in this age group.

Treatment is continued for up to two weeks after the infection has been cured.

How does Cancidas work?

The active substance in Cancidas, caspofungin, belongs to a group of antifungal medicines known as ‘echinocandins’. It works by interfering with the production of a component of the fungal cell wall called ‘glucan polysaccharide’, which is necessary for the fungus to continue living and growing. Fungal cells treated with Cancidas have incomplete or defective cell walls, making them fragile and unable to grow. The list of fungi against which Cancidas is active can be found in the Summary of Product Characteristics (also part of the EPAR).

How has Cancidas been studied?

Cancidas has been studied in five main studies.

Three studies looked at the effects of Cancidas in the treatment of invasive candidiasis or aspergillosis: one study involved 239 adults with invasive candidiasis, another involved 69 adults with invasive aspergillosis, and the third involved 49 patients aged between six months and 17 years with either candidiasis or aspergillosis. Cancidas was compared with amphotericin B given into a vein in the study of adults with invasive candidiasis.

For the empirical treatment of neutropenic febrile patients, Cancidas has been compared with amphotericin B in two studies: one involving 1,111 adults and another involving 82 patients aged between two and 17 years.

In all five studies, the main measure of effectiveness was the number of patients who responded to treatment. This is based on the improvement of their symptoms, as well as other criteria, such as elimination of the fungus from samples taken from the patients.

What benefit has Cancidas shown during the studies?

In invasive candidiasis, 73% of the adults treated with Cancidas who could be assessed had a favourable response (80 out of 109), compared with 62% of the adults treated with amphotericin B (71 out of 115).

In invasive aspergillosis, 41% of the adults had a favourable response at the end of the study (26 out of 63). Of the adults who did not respond to other treatments, 36% responded to Cancidas (19 out of 53). Of those who did not tolerate other treatments, 70% responded to Cancidas (7 out of 10).

Similar responses were seen in children and adolescents: 50% of those with invasive candidiasis (5 out of 10) and 81% of those with invasive aspergillosis (30 out of 37) responded to Cancidas.

In the empirical treatment of febrile neutropenic patients, Cancidas was as effective as amphotericin B. In the adult study, 34% of both groups of adults had a favourable response. Similar results were seen in the study of children and adolescents.

What is the risk associated with Cancidas?

The most common side effect with Cancidas (seen in more than 1 patient in 10) is fever. For the full list of all side effects reported with Cancidas, see the Package Leaflet.

Cancidas should not be used in people who may be hypersensitive (allergic) to caspofungin or any of the other ingredients.

Why has Cancidas been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Cancidas’s benefits are greater than its risks for the treatment of invasive candidiasis or aspergillosis, and empirical therapy for presumed fungal infections, in adult or paediatric patients. The Committee recommended that Cancidas be given marketing authorisation.

Cancidas was originally authorised under ‘Exceptional Circumstances’, because limited information was available at the time of approval. As the company had supplied the additional information requested, the ‘Exceptional Circumstances’ ended on 29 September 2006.

Other information about Cancidas

The European Commission granted a marketing authorisation valid throughout the European Union for Caspofungin MSD to Merck Sharpe and Dohme Limited on 24 October 2001. The name of the medicine was changed to Cancidas on 9 April 2003. The marketing authorisation was renewed on 24 October 2006.

This EPAR was last updated on 28/09/2011 .

More detail is available in the Summary of Product Characteristics

Product details

Publication details

Product information

07/09/2011  Cancidas -EMEA/H/C/000379 -R/0043

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.

Pharmaco-therapeutic Group

Antimycotics for systemic use

Therapeutic Indication

Treatment of invasive candidiasis in adult or paediatric patients. Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients.

Changes since initial authorisation of medicine

Initial Marketing authorisation documents