Summer is a joyous time for dog owners. We get to play with our furry friends outdoors, enjoying the sun. But the summer of 2021 was made extra special with the approval of Tanovea by the FDA. Tanovea is a rabacfosadine injection used to treat lymphoma in dogs. For the past four-and-a-half years, this treatment only had conditional approval. But all that changed on July 15, 2021. This makes it the first drug to receive full FDA approval for the treatment of lymphoma in dogs.
Tanovea approval journey
Tanovea first received conditional approval in December 2016 under the FDA’s Minor Use and Minor Species (MUMS) program. The program’s goal is to make medications for uncommon illnesses in major species more readily available. Pharmaceuticals face major financial roadblocks in putting such low-demand medicines on the market. MUMS drugs thus make treatments more affordable for pet owners while simultaneously giving pharmaceuticals a chance to market and perfect their medicines in real-time. With this approval, VetDC (the company behind Tanovea) could carry out further studies to collect conclusive data on the effectiveness of Tanovea.
The study that won the day
According to the FDA, “a well-controlled” study involving a total of 158 dogs demonstrated the safety and effectiveness of Tanovea. The dogs could be of any breed excluding West Highland White Terriers, which have a high tendency to develop pulmonary fibrosis. Pulmonary fibrosis was a known potential side effect of Tanovea even before the medicine had conditional approval. The dogs in the study were diagnosed with “multicentric lymphoma with at least one enlarged peripheral lymph node.”
The dogs were split into two groups, the Tanovea group and the placebo group. The Tanovea group had dogs between the ages of one and fifteen years, while the placebo group dogs were a little older, between three and sixteen years. For the safety evaluation, there were 120 dogs in the Tanovea group and 38 in the placebo group. Only 148 dogs were evaluated for effectiveness, with 112 dogs in the Tanovea group and 36 in the placebo group.
The results of the study showed that Tanovea extended the median survival rate by 61 days. Dogs that had a complete response to the medication experienced a median progression-free survival extension of up to 168 days.
What this means for owners
For the first time ever, owners can be assured of high quality, FDA-approved treatments when their dog has cancer. Cancer makes life miserable for the dog, hence some owners worry that treatments may negatively affect their dog’s quality of life. This doesn’t have to be a concern anymore. Now owners can look forward to enjoying more time with their dogs as they receive treatment.
The success of the MUMS program, in this case, could also help set the precedent for more uncommon illness medications to become available to the market.
Like all medications, Tanovea has some side effects that owners should expect. The dogs observed in the study experienced diarrhoea, vomiting, a decreased appetite, lethargy, weight loss and neutropenia (a decrease in a type of white blood cells known as neutrophils). In the more serious cases, pulmonary fibrosis developed. These serious cases also showed signs of skin issues such as infections, skin peeling and ulcerations.
This approval serves as a much-needed win in the fight against canine cancer. Lymphoma constitutes almost a quarter of all cancer cases, despite it only affecting less than 70, 000 dogs in the US each year. You can read more about lymphoma here