Pfizer's Canine Cancer Drug Palladia Gets FDA Approval - Update
6/3/2009 10:44 AM ET
(RTTNews) - Wednesday, Pfizer Animal Health, a unit of Pfizer Inc. (PFE: News ), said that the U.S. Food and Drug Administration, or FDA, has approved Palladia, or toceranib phosphate, the first canine cancer therapy in the U.S.
Pfizer intends to make the product available for purchase in early 2010. Meanwhile, Pfizer will introduce Palladia to boarded specialists in the weeks and months ahead to expand the body of clinical experience with this new therapy.
Palladia tablet is indicated to treat Patnaik grade II or III recurrent cutaneous mast cell tumors with or without regional lymph node involvement.
Pfizer Animal Health estimates that 1.2 million new canine cancer cases are reported in the U.S. every year and according to the Morris Animal Foundation, cancer is a leading cause of death in dogs.
"At the completion of a Palladia clinical study, approximately 60% of dogs had their tumors disappear, shrink or stop growing. Also, we determined that dogs whose tumors responded to Palladia experienced an improved quality of life," said Cheryl London, who has helped Pfizer Animal Health's Veterinary Medicine Research & Development to develop Palladia since 2000.
PFE is trading at $14.73, down $0.25 or 1.74%, on a volume of about 10.5 million shares.
by RTT Staff Writer
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FDA approves Pfizer's Palladia to treat mast-cell tumors in dogs
Jun 3, 2009
Rockville, Md. -- Pfizer's Palladia (Toceranib phosphate) just received approval by the Food and Drug Administration (FDA). The drug is the first one developed specifically for the treatment of cancer in dogs, the FDA reported today.
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.
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