(WWTI) — The U.S Food and Drug Administration fully approved Tanovea, which can be used to treat lymphoma in dogs.
Tanovea became the first conditionally approved new animal drug for dogs, achieving the FDA’s full approval on Thursday. Initially Tanovea received conditional approval under statutory provisions which allowed it to be used on minor species of animals, such as fish, parrots and guinea pigs, under the FDA’s Minor Use and Minor Species (MUMS) program in 2016.
Prior to full approval, the effectiveness of Tanovea was studied through a clinical study involving 158 dogs that had been diagnosed with multicentric lymphoma. The study found that Tanovea extended the median survival rate by 61 days, for dogs with a complete response to the drugs the median progression-free survival was extended to 168 days.
Steven M. Solomon, M.P.H., D.V.M., director of the FDA’s Center for Veterinary Medicine, said the approval can make a significant difference.
“Today’s approval shows that drugs to treat rare animal diseases, like canine lymphoma, can go through the FDA’s conditional approval pathway to reach full approval. This gives veterinarians another important tool to help extend the quality of life for dogs with lymphoma, and potentially give them and their owners more time together,” Solomon said.
“While canine lymphoma affects fewer than 70,000 dogs in the U.S. annually, it accounts for up to 24 percent of all cancers in dogs, making it one of the most significant canine cancers. For the first time, dog owners have the assurance of a treatment that has fully met the FDA’s standards for effectiveness in dogs.”