Commonly Asked Questions from Veterinarians
Q. What is canine oral melanoma?
A. Canine oral melanoma is an aggressive cancer of dogs, most commonly occurring in the oral cavity, nail bed, footpad and mucocutaneous junctions. It also can occur in a dog’s skin. Melanoma is the most common oral tumor in dogs.1
Q. What treatment options currently exist for the disease?
A. Traditional therapeutic options for canine oral melanoma may include: surgery to remove the tumor; radiation therapy to treat any tumor cells in the surrounding tissues and local lymph nodes; and chemotherapy for any tumor cells that have metastasized. Because oral melanoma has a history of being highly resistant to chemotherapy, researchers have focused on immunotherapy to address metastatic disease.1,2
Q. How does Canine Melanoma Vaccine, DNA work?
A. This therapeutic vaccine uses DNA expressing the human tyrosinase gene. The tyrosinase encoded by the xenogeneic (different-species) DNA used in this vaccine is homologous to canine tyrosinase and has been shown to stimulate an immune response to canine melanoma cells expressing tyrosinase. The use of DNA from a non-canine species results in tyrosinase that is not considered a self-antigen by the canine immune system, thereby stimulating a good immune response. The human tyrosinase protein is different enough from the canine tyrosinase protein that it will stimulate an immune response. Yet it is similar enough to the canine tyrosinase that the immune response will target canine melanoma cells.1,2
Q. What data prove the efficacy of this therapeutic vaccine?
A. Studies of xenogeneic DNA melanoma vaccines led by Philip Bergman, DVM, MS, PhD, Dipl ACVIM Onc., from 2000 to the present have included more than 100 dogs with oral melanoma and have produced promising results. While the effect of DNA vaccines varies from one animal to another, dogs that have participated in vaccine studies have recorded increased survival times.1,2 Data from these studies has been published in Vaccine, Cancer Immunity and Clinical Cancer Research.
Q. What is the indication for using this therapeutic vaccine?
A. The vaccine is indicated for the treatment of dogs with stage II or III oral melanoma for which local disease control has been achieved.3
Q. Can other medications and/or treatments be used concurrently?
A. There are no known contraindications for use of this product in dogs with oral melanoma.3
Q. What adverse effects have been documented following use of the vaccine?
A. A transient, low-grade fever may be observed in some dogs.
Q. What is the dosage for Canine Melanoma Vaccine, DNA, and how and where is it administered?
A. The therapeutic vaccine is administered transdermally in four doses biweekly. Dogs should receive a booster dose every six months thereafter. Each 0.4 mL dose is injected in the medial thigh using the Canine Transdermal Device.3
Q. What is the difference between the VET JET™ transdermal vaccination system and the Canine Transdermal Device?
A. The strengths of the spring systems in the two devices are different and cannot be interchanged. The VET JET™ has only been approved for use in cats for the administration of PUREVAX® Feline Leukemia vaccine. The Canine Transdermal Device has a much stronger spring system for intramuscular administration in dogs. It is approved solely for use with Canine Melanoma Vaccine, DNA.
Q. Since this is a vaccine, can it be used as a preventive?
A. Currently, this vaccine has only been tested and conditionally approved for use as a therapeutic vaccine in dogs that have oral melanoma. Most experts believe that the incidence of canine oral melanoma is too low to justify a preventive vaccine for all dogs.
Q. What is a conditional license? What does it mean for this vaccine?
A. The USDA may issue a conditional product license to meet an emergency condition, a limited market or other special circumstance. To obtain conditional licensure, purity and safety must be assured as well as a reasonable expectation of efficacy. During the period of the conditional license, additional research will be done to further support the safety and efficacy of the vaccine.4
Q. Why isn’t Canine Melanoma Vaccine, DNA available to general practitioners?
A. This is a unique biotherapeutic with a highly specialized mode of action. It is critical to maintain control over the proper use of this vaccine in clinical cases. While the vaccine is governed by a conditional license, Merial will be working with specialists practicing veterinary oncology to monitor and gather additional efficacy and safety data regarding the vaccine. Veterinarians are encouraged to work with specialists in their area for referrals.
Q. How do I find a cancer specialist to whom I can refer potential patients?
A. If you require assistance to locate a cancer specialist, please visit www.acvim.org and www.vetcancersociety.org.
Q. Where can I get additional information about Canine Melanoma Vaccine, DNA?
A. For additional information about the vaccine, please contact Merial Technical Solutions at 1-888-MERIAL-1, Option 3.
NOTICE: The USDA has issued a conditional U.S. Veterinary Biological Product License for this therapeutic vaccine. This conditional license is a response to an application and assurance of safety and purity, and a reasonable expectation of efficacy based on initial trials.1,2
During this period of conditional license, additional research will be conducted to further support the safety and efficacy of the vaccine. Production under this license is in compliance with all regulations and standards applicable to such products.
1Bergman PJ, et al. Development of a xenogeneic DNA vaccine program for canine malignant melanoma at the Animal Medical Center. Vaccine 2006;24:4582-4585.
2Bergman PJ, et al. Long-Term Survival of Dogs with Advanced Malignant Melanoma after DNA Vaccination with Xenogeneic Human Tyrosinase: A Phase I Trial. Clinical Cancer Research 2003;9:1284-1290.
3Product label.
4Code of Federal Regulations, Title 9 Animals and Animal Products Part 102 — Licenses for Biological Products. Available at: http://www.washingtonwatchdog.org/documents/cfr/title9/part102.html. Accessed November 2, 2006.
®PUREVAX is a registered trademark, and ™VET JET is a trademark, of Merial.
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