For the first time, the U.S. Food and Drug Administration has fully approved a treatment for canine lymphoma, awarding the status to VetDC Inc. and its drug Tanovea.
“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,” said Steven M. Solomon, MPH, DVM, director of the FDA’s Center for Veterinary Medicine. “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.”
Tanovea (rabacfosadine injection) is administered intravenously for 30 minutes every three weeks for up to five sessions, according to VetDC. The drug earned conditional approval in 2016.
Canine lymphoma affects fewer than 70,000 dogs in the U.S. annually but accounts for up to 24% of all cancers in dogs, Dr. Solomon said.
Tanovea for cats is undergoing a pilot safety study, according to VetDC.
The Fort Collins, Colorado, company was launched in 2010 through a partnership with Colorado State University’s Flint Animal Cancer Center.
“Today’s approval of Tanovea marks the first time ever that an animal drug for dogs has advanced from conditional to full approval under the FDA’s Minor Use and Minor Species (MUMS) program,” said VetDC’s CEO, Steven J. Roy, MBA. “This is an important advancement for the veterinary oncology community and is exciting news for pet parents looking to treat their beloved dogs with lymphoma.
“The VetDC team has worked tirelessly with leading veterinary hospitals across the U.S. to provide robust clinical data that culminated in meeting the FDA’s ‘substantial evidence’ standard of effectiveness for full approval.”
Another canine lymphoma drug, Laverdia-CA1 (verdinexor tablets) from Anivive Lifesciences Inc., received conditional FDA approval in January 2021.
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