FDA: First Drug to Treat Cancer in Dogs Approved

The U.S. Food and Drug Administration today announced the approvalof Palladia (toceranib phosphate), the first drug developedspecifically for the treatment of cancer in dogs.

Palladia is approved to treat canine cutaneous (skin-based) mastcell tumors, a type of cancer responsible for about 1 out of 5 casesof canine skin tumors. The drug is approved to treat the tumors withor without regional lymph node involvement.

All cancer drugs now used in veterinary medicine originally weredeveloped for use in humans and are not approved for use in animals.Cancer treatments used in animals are used in an “extra-label”manner as allowed by the Animal Medicinal Drug Use Clarification Actof 1994.

“This cancer drug approval for dogs is an important step forward forveterinary medicine,” said Bernadette Dunham, D.V.M., Ph.D.,director of FDA’s Center for Veterinary Medicine. “Prior to thisapproval, veterinarians had to rely on human oncology drugs, withoutknowledge of how safe or effective they would be for dogs. Today’sapproval offers dog owners, in consultation with their veterinarian,an option for treatment of their dog’s cancer.”

While canine mast cell tumors often appear small and insignificant,they can be a very serious form of cancer in dogs. Some mast celltumors are easily removed without the development of any furtherproblems, while others can lead to life threatening disease.

Palladia is a tyrosine kinase inhibitor and works in two ways: bykilling tumor cells and by cutting off the blood supply to thetumor. In a clinical trial, Palladia showed a statisticallysignificant difference in tumor shrinkage when compared with aninactive substance (placebo).

The most common side effects associated with Palladia are diarrhea,decrease or loss of appetite, lameness, weight loss, and blood inthe stool.

Palladia is manufactured by Pfizer Animal Health Inc., New York City.


For more information, check out:


Freedom of Information Summary — Original New Animal Drug Application

Palladia — toceranib phosphate tablets for dogs — approved May 22,2009

For the treatment of Patnaik grade II or III, recurrent, cutaneousmast cell tumors with or without regional node involvement in dogs– Sponsored by Pharmacia & Upjohn Company, a Division of Pfizer, Inc.



Janet’s Veterinary Medicine Blog’  Janet Tobiassen, DVM



Palladia Client Information Sheet