What is Cancidas?
Cancidas is a powder that is converted into a solution for infusion (drip into a vein) that contains the active substance caspofungin.
What is Cancidas used for?
Cancidas is an antifungal medicine indicated for the treatment of adults, adolescents and children with:
- invasive candidiasis (a type of infection due to the Candida fungus);
- invasive aspergillosis (another type of infection due to the Aspergillus fungus), in subjects who do not respond or are intolerant to amphotericin B or itraconazole (other antifungal medicines);
- presumed fungal infections (such as Candida or Aspergillus) in patients with fever and neutropenic (with a reduced number of white blood cells). It is an "empirical therapy", that is started on the basis of the observation of the patient before the doctor has the confirmation of the infection.
The medicine can only be obtained with a prescription.
How is Cancidas used?
Cancidas therapy should be started by a doctor experienced in the treatment of invasive fungal infections. Cancidas must be reconstituted in solution before use, avoiding the use of diluents containing glucose.
It should be given once a day by slow intravenous infusion over about an hour. In adult patients the therapy starts with a loading dose of 70 mg, followed by a dose of 50 mg a day or 70 mg in patients with a body weight above 80 kg. A lower dose may be necessary in adults with moderate liver problems.
In patients aged 12 months to 17 years, the dose depends on the body surface (calculated based on the height and weight of the patient). Cancidas should be used with caution in children under the age of 12 months, as it has not been sufficiently studied in this age group.
The treatment should be continued for up to two weeks after healing from the infection.
How does Cancidas work?
The active substance in Cancidas, caspofungin, belongs to a group of antifungal medicines called "echinocandins". The medicine works by interfering with the production of a component of the fungal cell wall called "glucan polysaccharide" which is necessary for the survival and growth of the fungus. Mushroom cells exposed to Cancidas have an altered or incomplete cell wall, which makes them fragile and unable to grow. The summary of product characteristics (also included with EPAR) includes the list of fungi for which Cancidas is active.
How has Cancidas been studied?
Cancidas has been studied in five main studies.
Three studies examined the effects of Cancidas in the treatment of candidiasis or invasive aspergillosis: one study was performed on 239 adults with invasive candidiasis, another study was conducted on 69 adult patients with invasive aspergillosis, the third study involved 49 patients aged between six months and 17 years with candidiasis or aspergillosis. The study on adults with invasive candidiasis compared Cancidas with intravenously administered amphotericin B.
For the empirical therapy of neutropenic patients with fever, Cancidas was compared with amphotericin B in two studies: one was performed on 1 111 adults and another on 82 patients between two and 17 years.
In all five studies, the main measure of effectiveness was the number of patients who responded to treatment. This number depended on symptom improvement and other criteria such as the disappearance of the fungus from patient samples.
What benefit has Cancidas shown during the studies?
In invasive candidiasis, 73% of evaluable adults treated with Cancidas responded positively (80 out of 109) compared to 62% of adult patients treated with amphotericin B (71 out of 115).
For invasive aspergillosis, at the end of the study 41% of adults had responded positively (26 of 63). Of the adults who did not respond to other treatments, 36% were responsive to Cancidas (19 out of 53). Of patients intolerant to other therapies, 70% responded to Cancidas (7 out of 10).
Similar responses have been recorded in children and adolescents: 50% of subjects suffering from invasive candidiasis (5 out of 10) and 81% of patients with invasive aspergillosis (30 out of 37) responded to Cancidas.
In empirical therapy of neutropenic fever patients, Cancidas demonstrated the same efficacy as amphotericin B. In the adult study, 34% of both groups of adults responded positively. Similar results were observed in the study of children and adolescents.
What is the risk associated with Cancidas?
The most frequently reported undesirable effect (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 other ingredients in the medicine.
Why has Cancidas been approved?
The Committee for Medicinal Products for Human Use (CHMP) is of the opinion that the benefits of Cancidas outweigh its risks for the treatment of invasive candidiasis or aspergillosis and empirical therapy for presumed fungal infections in adult or pediatric patients. The Committee therefore recommended that Cancidas be given marketing authorization.
Cancidas was initially authorized in "exceptional circumstances" because only limited information was available at the time the authorization was granted. As the company provided the additional information requested, the condition referring to "exceptional circumstances" was removed on 29 September 2006.
More information on Cancidas
On 24 October 2001, the European Commission issued a marketing authorization valid for Caspofungin MSD, valid throughout the European Union, to Merck Sharpe and Dohme Limited. On 9 April 2003 the name of the medicine was changed to Cancidas. The marketing authorization was renewed on 24 October 2006.
The full EPAR for Cancidas can be found here.
Last update of this summary: 11-2008.
