Excerpts taken from original story: VetDC’s Canine Lymphoma Drug Makes History, TODAY’S VETERINARY BUSINESS, July 2021

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.”

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.””

To read the full story: VetDC’s Canine Lymphoma Drug Makes History

Logo image of the US Food & Drug Administration

Excerpt taken from the US Food & Drog Administration News Release:  FDA Grants First Full Approval for Treatment of Lymphoma in Dogs, July 15, 2021

“Today, the U.S. Food and Drug Administration fully approved Tanovea (rabacfosadine injection) to treat lymphoma in dogs. Lymphoma, also called lymphosarcoma, is a type of cancer that can affect many species, including dogs. Tanovea is the first conditionally approved new animal drug for dogs to achieve the FDA’s full approval.

 

Tanovea was approved using the new animal drug approval process after initially receiving conditional approval under statutory provisions related to drugs intended for uncommon diseases or conditions in major animal species (minor uses) or for use in the minor species of animals under the FDA’s Minor Use and Minor Species (MUMS) program (i.e., MUMS drugs).”

 

“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,” said Steven M. Solomon, M.P.H., D.V.M., director of the FDA’s Center for Veterinary Medicine. “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.”

To read the full story: FDA Grants First Full Approval for Treatment of Lymphoma in Dogs