The 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
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.
Yesterday's action follows the recommendation of FDA's Antiviral Drugs Advisory
Committee, which discussed Cancidas at a public meeting on January 10, 2001.