“Manufactured by Pfizer Animal Health Inc., based in New York City, the drug marketed as Palladia, or chemically known as toceranib phosphate, will hit the markets in early 2010.
“This cancer drug approval for dogs is an important step forward for veterinary medicine,” Bernadette Dunham, D.V.M., Ph.D., director of FDA’s Center for Veterinary Medicine, said in a released statement.
“Prior to this approval, veterinarians had to rely on human oncology drugs, without knowledge of how safe or effective they would be for dogs. Today’s approval offers dog owners, in consultation with their veterinarian, an option for treatment of their dog’s cancer.”
Current cancer drugs used in veterinary medicine are in fact not approved for use in animals, as they were originally designed for human use. But vets are allowed to administer human cancer medicine and other treatments under Federal law for controlled substances, per Animal Medicinal Drug Use Clarification Act of 1994.
Before Palladia’s mainstream release, Pfizer plans to introduce Palladia to boarded specialists to expand the body of clinical experience with the United States’ first canine cancer therapy.
“At the completion of a Palladia clinical study, approximately 60 percent of dogs had their tumors disappear, shrink or stop growing,” said Cheryl London, who has helped Pfizer Animal Health’s Veterinary Medicine Research & Development to develop Palladia since 2000.
Palladia is a tyrosine kinase inhibitor and works in two ways: by killing tumor cells and by cutting off the blood supply to the tumor. In a clinical trial, Palladia showed a statistically significant difference in tumor shrinkage when compared with the placebo.”