Health

FDA Approves First Drug To Treat Cancer in Dogs

| by FDA

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

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

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All cancer drugs now used in veterinary medicine originally
were developed 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 Act of
1994.

"This cancer drug approval for dogs is an important step
forward for veterinary medicine," said Bernadette Dunham, D.V.M.,
Ph.D., director of FDA's Center for Veterinary Medicine. "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."

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

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 an inactive substance
(placebo).

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

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

For more information:

Palladia approval summary