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Virbac Announces FDA Approval of New Cancer Treatment for Dogs

It’s derived from an Australian rainforest plant.

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(PRESS RELEASE) DALLAS – Virbac announces the breakthrough drug STELFONTA (tigilanol tiglate injection) that has been approved by the U.S. Food and Drug Administration (FDA) as a non-surgical alternative for treating canine mast cell tumors in dogs, is now available in veterinary clinics throughout the United States. Australian company QBiotics discovered the biologically active pharmaceutical ingredient, tigilanol tiglate, in the seed of the Australian native blushwood tree from the rainforest of North Queensland.

According to the Morris Animal Foundation, cancer is the leading cause of death for dogs over two years old. Mast cell tumors are the most common type of skin cancer in dogs and often appear as a nodule on or just underneath the skin. While typical treatment options include surgery, chemotherapy and radiation, these treatments may not be appropriate for every dog. STELFONTA is injected directly into the tumor and works by activation of the local innate immune system with destruction of the tumor cells and tumor blood supply leading to tumor destruction. STELFONTA goes on to promote complete healing of the typical tissue deficit left after tumor removal with minimal scar formation. While sedation is not usually required, it may be necessary to safely and accurately administer STELFONTA.

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“We are blazing a new trail in the treatment of canine skin tumors and are pleased to offer STELFONTA to veterinarians across the U.S.,” said François Fournier, president and CEO of Virbac North America. “We’re very proud of our collaborative success with QBiotics to bring STELFONTA to the veterinary community and dog owners. STELFONTA will allow veterinarians a less invasive alternative to surgery, and a new option for pet owners who prefer to avoid the risk of general anesthesia for their pets. We encourage veterinarians and pet owners to visit the STELFONTA website to learn more about the risks and benefits of STELFONTA.”

STELFONTA is approved for the treatment of non-metastatic, cutaneous mast cell tumors anywhere on a dog’s body and non-metastatic, subcutaneous mast cell tumors located in the lower parts of dogs’ legs. STELFONTA can induce a substantial but transitory local inflammatory reaction which may result in pain, bruising, and swelling. Therefore, as with surgery, pain control medication is recommended. Among dogs treated with STELFONTA in the registration clinical trial conducted in the U.S., 75 percent of mast cell tumors achieved a complete response (complete tumor removal) of the injected tumor with just one treatment and nearly all of the tumor sites healed within six weeks. Some wounds can be more extensive and may require additional management and healing time. In this same controlled clinical trial, interventions (e.g., e-collar, bandages) to manage wounds were minimal and only required in five of 117 cases.

“STELFONTA is a medical breakthrough for the treatment of mast cell tumors in dogs and there’s no other treatment like it,” said Dr. Cristiano von Simson, DVM, director of veterinary services at Virbac. “It mobilizes the local immune cells to destroy the tumor and then promotes the growth of healthy tissue. As with any manipulation of a mast cell tumor there is the potential risk for serious mast cell degranulation when treating with STELFONTA. However, this can be managed with pre- and post-treatment concomitant medications as noted in the prescribing information. Although STELFONTA has not been evaluated in dogs with signs of systemic disease due to a mast cell tumor, STELFONTA can be an alternative option to treat local skin tumors in older dogs who are at increased risk from surgery or chemotherapy, or in cases where the dog owner isn’t comfortable with surgery or anesthesia.”

Since STELFONTA received approval from the FDA, roughly 88 percent of U.S. veterinarians polled who have used STELFONTA to treat canine mast cell tumors reported satisfactory experiences. STELFONTA has also received approval from regulatory agencies in Australia, Europe and the United Kingdom for the treatment of canine mast cell tumors.

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STELFONTA may cause extensive wound formation at the tumor site, including cellulitis and severe tissue sloughing that may require additional management and healing time. The most common adverse reactions seen in the clinical trial were wound formation, injection site pain, lameness in the treated limb, vomiting, diarrhea, hypoalbuminemia, and injection site bruising. Sedation of the dog may be necessary to safely and accurately administer STELFONTA to decrease the chance of accidental self-injection that may cause local inflammation and wound formation. The safe use of STELFONTA has not been evaluated in dogs younger than 3.5 years old. For more information on STELFONTA and full prescribing information, visit here. Virbac Veterinary Technical Support also offers consultation to veterinarians regarding STELFONTA and mast cell case management at 1.800.338.3659.

QBiotics is an Australian life sciences company which discovers, develops and commercializes novel anticancer and wound healing pharmaceuticals for human and veterinary markets. QBiotics is currently investigating a human formulation containing tigilanol tiglate in a range of cancer types in humans, including melanoma and head squamous cell carcinoma.

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