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The Food and Drug Administration (FDA) announced full approval for lymphoma treatment in dogs on Thursday, aiming to benefit quality of life and allow pets and their owners more time together.
The injection, called Tanovea, cleared regulatory hurdles after it first gained conditional approval in 2016 through the FDA’s Minor Use and Minor Species (MUMS) program, "designed to help pharmaceutical companies overcome the financial roadblocks they face in providing limited-demand animal drugs," per an agency release. Additional studies since conditional approval met the evidence needed for full approval, awarded to VetDC Inc.
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Lymphoma stems from abnormal growth of white blood cells, said to affect any organ but commonly begins in the lymph nodes, spleen and bone marrow. Signs of the disease in dogs can vary and its cause in dogs is unknown, per the FDA.
A study involving 158 dogs "diagnosed with multicentric lymphoma with at least one enlarged peripheral lymph node," including at least 120 treated with Tanovea, saw an added 61 days of survival on average. Other results suggested the drug lent an additional 168 days to live with the disease without progressing in severity.
The prescribed drug works by killing growing cancer cells with an active ingredient called rabacfosadine. It's administered five times, with each injection spaced three weeks apart. Side effects include "diarrhea, decreased appetite, vomiting, lethargy, weight loss and neutropenia," while serious events can include "pulmonary fibrosis and skin issues, including infection, ulceration and skin peeling in some cases."
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According to Steven M. Solomon, M.P.H., D.V.M., director of the FDA’s Center for Veterinary Medicine, the disease affects fewer than 70,000 dogs in the U.S. each year but serves as "one of the most significant canine cancers," comprising up to 24% of all cancers afflicting dogs.
"For the first time, dog owners have the assurance of a treatment that has fully met the FDA’s standards for effectiveness in dogs," Solomon said.