FRIDAY, July 16, 2021 (HealthDay News) – The first full approval of a drug for the treatment of lymphoma in dogs was granted by the U.S. Food and Drug Administration.
“While less than 70,000 dogs are affected by canine lymphoma each year in the US, it accounts for up to 24% of all canine cancers, making it one of the most important canine cancers,” said Steven Solomon, director of the Veterinary Center at the FDA said in a press release from the agency. “For the first time, dog owners can rest assured of a treatment that fully meets FDA standards for effectiveness in dogs.”
Tanovea had previously received conditional approval under the FDA’s Minor Use and Minor Species program.
At the time, the agency concluded that the drug was safe and had “reasonable expectation of effectiveness” for treating rare cases of lymphoma in dogs. The conditional approval enabled drug maker VetDC Inc. to commercialize Tanovea while collecting additional study data for full approval.
The study included 158 dogs with lymphoma who received either Tanovea (120) or a placebo (38). Their ages ranged from 1 to 15 years in the Tanovea group and from 3 to 16 years in the placebo group.
Overall, the drug increased median survival by 61 days. In dogs with a complete response to the drug, the median progression-free survival was increased to 168 days, the results showed.
Tanovea’s approval “shows that drugs used to treat rare animal diseases such as canine lymphoma can pass the FDA conditional approval path for full approval. This gives veterinarians another vital tool in extending the quality of life for dogs with lymphoma and potentially giving them and their owners more time together, “noted Solomon.
The most common side effects in Tanovea-treated dogs were diarrhea, decreased appetite, vomiting, lethargy, weight loss, and neutropenia (a decrease in a type of white blood cell), according to the FDA. The most serious adverse events included pulmonary fibrosis and skin problems such as infections, ulcers, and peeling skin.
Veterinarians should warn pet owners of potential adverse events and side effects before administering the drug to dogs and provide owners with the customer information sheet for the product, the FDA said.
The American Kennel Club has more about canine lymphoma.
SOURCE: US Food and Drug Administration, news release, July 15, 2021