The first full approval of a drug has been given by the US Food and Drug Administration to treat lymphoma in dogs. The FDA has fully approved Tanovia (rabacfosadine injection) for the treatment of lymphoma in dogs. Lymphoma, also known as lymphosarcoma, is a type of cancer that can affect many species, including dogs. Tanovia is the first conditionally approved new animal drug for dogs to receive full FDA approval.
Tanovea was approved using the new animal drug approval process, initially from drugs for unusual diseases or conditions in major animal species (minor use) or for use in smaller species of animals under the FDA’s approval of minor use and Small Species (MUMS) program (i.e. MUMS drugs) after obtaining conditional approval under relevant statutory provisions.
Acting FDA Commissioner Janet Woodcock, M.D. said in her statement, “The FDA is dedicated to making treatment options available for all patients – including animals suffering from rare conditions. Today’s first-ever full approval of a new animal drug for treating lymphoma in dogs demonstrates the positive impact that the FDA’s Minor Use and Minor Species program can have on the availability of novel animal treatments”. She further added, “We’re committed to continuing using all our authorities to help make limited-demand treatment options available to our animal companions”.
At the time, the agency concluded that the drug was safe and there was a “reasonable expectation of effectiveness” for treating rare cases of lymphoma in dogs. The conditional approval allowed drug maker VetDC Inc. permitted to market Tanovea while collecting additional study data for full approval.
The approval of Tanovea “shows that drugs to treat rare animal diseases, such as canine lymphoma, can reach full approval by the FDA’s conditional approval route. It is designed to help veterinarians increase the quality of life for dogs with lymphoma and potentially give them and their owners more time together”.
The FDA said the most common side effects in dogs treated with Tanovea include diarrhea, loss of appetite, vomiting, lethargy, weight loss, and neutropenia. The most serious adverse events included pulmonary fibrosis and skin problems such as infection, ulceration, and peeling of the skin.