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19 July 2021

TANOVEA® (rabacfosadine for injection) Receives Full FDA Approval as First Treatment for Lymphoma in Dogs; Elanco Acquires Product from VetDC, Inc

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Posted By: Sarah Morehouse

GREENFIELD, Ind. (July 19, 2021) Today, Elanco Animal Health Incorporated (NYSE: ELAN) announced that the  FDA has granted full approval of Tanovea for the treatment of lymphoma in dogs, making this the first conditionally approved new animal drug for dogs that has ever advanced from a conditional to full FDA approval under the FDA’s Minor Use and Minor Species (MUMS) program. Concurrently, Elanco announced the acquisition of the product from VetDC, Inc., which it licensed for further development and commercialization in 2019.

With the full approval, Tanovea becomes one of the most comprehensively studied treatment options for canine lymphoma. The robust scientific evidence of Tanovea’s effectiveness and safety in dogs with lymphoma offers a product the veterinary oncology community can rely on as they guide their patients through their lymphoma treatment journey.

“Tanovea provides veterinarians and pet owners with a novel treatment option for canine lymphoma, of which there are few,” said Aaron Schacht, executive vice president, Innovation, Regulatory and Business Development of Elanco. “Working in collaboration with VetDC allowed us to utilize innovation originally intended for humans to demonstrate efficacy in dogs, and ultimately gain full approval from CVM for Tanovea.”

One in four dogs will be diagnosed with cancer in their lifetime – with lymphoma being one of the most common types of cancer seen by veterinarians.1 A lymphoma diagnosis can be a challenging time for pet owners, but with Tanovea, veterinary oncologists can offer renewed confidence with a different treatment option than what they’ve relied on in the past. Tanovea works differently than other commonly used treatments and is specifically designed to target lymphoma cells. 1–4 In the pivotal study, Tanovea demonstrated a statistically significantly longer median progression free survival time (PFS) compared to placebo (p<0.0001), with a median PFS of 151 days in responding dogs (partial or complete response) and 168 days in dogs with a complete response. For dogs with B-cell lymphoma, 80.4% of dogs responded to Tanovea treatment. In addition, Tanovea is dosed in 3-week intervals, allowing more quality time together for pet and owner between treatments.

"We are excited to see our high-science approach of conducting comprehensive clinical studies with leading academic and private veterinary hospitals culminate in this landmark approval", says Steven Roy, President & CEO of VetDC. “I am tremendously proud of the outstanding work and dedication of the entire VetDC team to bring Tanovea to full FDA approval. We are grateful for Elanco's collaborative relationship and look forward to seeing Elanco advance this important lymphoma treatment further within the veterinary oncology community.”

For more information about Tanovea, call 1-888-545-5973.

References:

  1. Saba CF et al. Vet Comp Oncol. 2018;16(1):E76–E82.
  2. DrugBank. Cyclophosphamide [Internet]. 2021 [cited 2021 Mar4]. Available from: https://go.drugbank.com/drugs/DB00531.
  3. DrugBank. Doxorubicin [Internet]. 2021 [cited 2021 Mar 4]. Available from: https://go.drugbank.com/drugs/DB00997.
  4. DrugBank. Vincristine [Internet]. 2021 [cited 2021 Mar 4].Available from: https://go.drugbank.com/drugs/DB00541.

INDICATION: For the treatment of lymphoma in dogs.

IMPORTANT SAFETY INFORMATION:

TANOVEA® (rabacfosadine for injection) is not for use in humans and should be kept out of the reach of children. Wear chemotherapy-resistant gloves to prevent contact with feces, urine, vomit, and saliva of treated dogs for five days following treatment. Rabacfosadine is cytotoxic and can cause birth defects and affect female and male fertility. Pregnant and breast-feeding women should not prepare or administer the product. Serious and sometimes fatal respiratory complications, including pulmonary fibrosis have occurred in dogs treated with Tanovea. Do not use in dogs with pulmonary fibrosis, a history of chronic pulmonary disease that could lead to fibrosis, or in breeds with a predisposition to this condition such as West Highland White Terriers. Use with caution in other terrier breeds. Do not use in dogs that are pregnant, lactating, or intended for breeding. Most common adverse reactions included neutropenia, diarrhea, vomiting, hyporexia, weight loss, and lethargy. For full prescribing information, call 1-888-545-5973.

ABOUT ELANCO

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose™ Sustainability/ESG Pledges – all to advance the health of animals, people and the planet.

Learn more at www.elanco.com.

ABOUT VETDC

VetDC, Inc., a Colorado State University startup, is changing the way new cancer medicines are developed for companion animals, leveraging novel advancements from human biotechnology that have demonstrated success in animal studies. To learn more, visit www.vetdc.com

Tanovea, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

© 2021 Elanco or its affiliates. PM-US-21-2035

Media Contact

Sarah Morehouse

+1.317.914.7568

SARAH.MOREHOUSE@network.elancoah.com

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Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2021 Elanco.
PM-US-21-2035