FDA approves Pfizer's Palladia to treat mast-cell tumors in dogs
The drug was cleared to treat canine cutaneous mast-cell tumors, a type of cancer responsible for about one out of five cases of canine skin tumors. Palladia was approved to treat tumors with or without regional lymph-node involvement.
"This cancer-drug approval for dogs is an important step forward for veterinary medicine," says FDA's Bernadette Dunham, DVM, PhD, in a prepared 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."
Palladia is a tyrosine kinase inhibitor and works 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 an inactive substance (placebo).
The most common side effects are diarrhea, decrease or loss of appetite, lameness, weight loss and blood in the stool, the FDA reports.