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January 29, 2001
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FDA has approved Cancidas (caspofungin acetate) Intravenous Infusion, a new anti-fungal medication for patients who are unresponsive to or cannot tolerate standard therapies for the invasive form of aspergillosis.
Cancidas is the first approved drug in a new class of anti-fungal agents called echinocandins, which are believed to work by disrupting the creation of fungal cell walls.
Invasive aspergillosis is a term used to describe a group of fungal infections caused by the fungus Aspergillus. Most healthy individuals are unaffected by this common fungus; however exposed individuals with weakened or abnormal immune systems may become seriously ill. In this population, this type of infection is often fatal.
FDA based its approval decision on the results of a small, multi- center, open-label, non-comparative study that was designed to evaluate the safety, tolerability and efficacy of Cancidas, as well as an integration of the efficacy information submitted in the preclinical and supportive clinical studies. This open-label study involved patients with invasive aspergillosis who were either unresponsive or intolerant of previous therapies. In addition, the Agency also considered the efficacy and safety of available therapies for invasive aspergillosis, and the risk-benefit analysis supporting the decision.
The applicant's assessment included the use of an independent expert panel who determined that overall 41% of patients had a favorable response. Looking at the type of patient and length of treatment affected the response rate for those patients who received more than 7 days of therapy with Cancidas, 47% had a favorable response. The favorable response rates for patients who were either unresponsive or intolerant of previous therapies were 36% and 70% respectively.
Since Cancidas has not been studied as initial therapy for invasive aspergillosis, this use is not recommended. In addition, until further information is available on the interaction of cyclosporin and Cancidas, their concomitant use is not recommended. Drug-related adverse events reported in patients treated with Cancidas include fever, phlebitis/thrombophlebitis and/or infused vein complications, headache, nausea, vomiting, rash, skin flushing and mild liver function test elevations, and a case of anaphylaxis.
Today's action follows the recommendation of FDA's Antiviral Drugs Advisory Committee, which discussed Cancidas at a public meeting on January 10, 2001.
Merck & Co., Inc., Whitehouse Station, NJ, is the sponsor of the approved New Drug Application (NDA) for Cancidas.
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