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Janet Tobiassen Crosby, DVM

Merial granted full licensure for canine melanoma vaccine

By January 11, 2010

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The canine melanoma vaccine, ONCEPT (tm), by Merial, was granted a conditional license approval by the USDA in March 2007. Today, CNNMoney reported that the USDA has granted full licensure for this anti-tumor vaccine.

I spoke with a veterinary technical services representative from Merial today who confirmed the full license approval. The company plans to introduce ONCEPT(tm) in Orlando, Florida during the January 16 - 20 North American Veterinary Conference.

Canine Melanoma
Cancer in dogs is unfortunately very common. Melanoma, a cancer of the cells that produce melanin pigment, is the most common malignant oral cancer of dogs. In addition to the mouth, melanoma can be seen in the eye, paw pads and nail beds and skin. Melanoma is highly malignant and can spread (metastasize) to the kidney, liver, lymph nodes and lungs very quickly.

Treatment for Melanoma

  • Surgery is the first step, and the surgeon takes margins around the mass as wide as possible. Because this tumor often shows up in small/difficult places such as the mouth, foot or eyelid, large margins are often difficult to obtain.
  • Chemotherapy has been of little value with this type of tumor.
  • Radiation therapy may extend survival times for earlier stages of this cancer.
  • Anti-tumor vaccine for melanoma has just received full approval after many clinical trials to determine its efficacy. This is a DNA-based vaccine, using a protein found on melanoma cells that is similar to, but not exactly the same as, the canine melanoma protein. The protein is called tyrosinase and is found on normal and cancerous melanoma cells. DNA technology is used to insert a non-canine gene so that the dog's immune system will recognize the altered tyrosinase protein as "foreign" and will work to find and destroy the cancerous melanoma cells.

    Learn more about this vaccine from Merial - PetCancerVaccine.com

Comparing Survival Times

According to the Animal Medical Center in New York where clinical trials were performed:

"These dogs [in the trials] had a median survival time of 389 days, a dramatic increase in survival (most dogs with advanced malignant melanoma have a median survival time of only 60-90 days with presently available therapies). There has been no toxicity noted in any dogs receiving DNA melanoma vaccines to date." Read full report

Is this vaccine right for your pet?
If your pet has been diagnosed with melanoma and you would like to know if the melanoma vaccine treatment option is a viable one for your pet, please speak to your veterinarian or consult a veterinary oncologist. Visit the Veterinary Cancer Society to find a veterinary oncologist for consultation.

Related Reading:
Development of a xenogeneic DNA vaccine program for canine malignant melanoma at the Animal Medical Center from Science Direct


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Comments

January 20, 2010 at 12:58 pm
(1) Mike says:

Interesting!

January 20, 2010 at 1:57 pm
(2) The Very Rev. Canon Daniel Beegan MOB says:

I lost one dog to melanoma, granted at an old age, but I will be asked my local veterinarian.

August 5, 2010 at 10:46 pm
(3) Lynn says:

I learned yesterday that all of the melanoma vaccines are on backorder. Many conflicting reports but one vet oncologist clinic told me the FDA has withdrawn the conditional approval. My little beloved yorkie has had two of the four initial doses. No one can tell me the effect of this. I am sick with worry. She has been doing so well and has an aggressive form of this disease. What can we do? Does anyone know?

August 5, 2010 at 10:56 pm
(4) Jill says:

Lynn, I’m in the same boat as you. My baby “Tobi” had two of the vaccines (last one 3 weeks ago). If you find out any information on this backorder….please let me know. I am very upset and hurt right now. Thanks~

October 27, 2010 at 7:12 am
(5) Miep Bos says:

For (3) Lynn: In Europe they want to perform those trails also, can you give me more information about withdrawing this vaccin? Is it stated on a website?

November 3, 2010 at 3:54 pm
(6) Judith says:

Our golden girl had a small melanoma on a paw. There is not much information about the vaccine for which we think she is candidate. Has anyone heard anymore about possible withdrawal of the vaccine?

Also, those of you who have had first dosages, can you share with me the costs you incurred to receive the vaccine itself? Thanks very much

January 7, 2011 at 3:36 pm
(7) Bruce Leffingwell, Sr. says:

Regarding the cost. We just had the four treatments completed on our dog by the UGA small dog school and the cost was over $2000.00.

I just hope the vaccine doesn’t cost the vet $100.00 and they are taking us to the cleaners.

Buy the way, my dog had multiple spots on his tongue and now after two months the spots are gone, and xrays show clear lungs. Spencer is 12 years old and now acts like a five year old.

January 7, 2011 at 3:36 pm
(8) Bruce Leffingwell, Sr. says:

Regarding the cost. We just had the four treatments completed on our dog by the UGA small dog school and the cost was over $2000.00.

I just hope the vaccine doesn’t cost the vet $100.00 and they are taking us to the cleaners.

Buy the way, my dog had multiple spots on his tongue and now after two months the spots are gone, and xrays show clear lungs. Spencer is 12 years old and now acts like a five year old.

March 26, 2011 at 8:15 pm
(9) Robin says:

My golden retriever was diagnosed with early stage Melanoma 2-1/2 years ago just before he turned 10. The tumor was on his gums which we had removed. The vet told us we had three options (which could be used in combination). Surgery, radiation and this vaccine. Surgery was very radical; to leave a suitable “margin” it required the removal of half his jaw. Radiation would leave him with a sore mouth and muzzle which meant months of no retrieving (his favorite activity). The vaccine usually has no side effects so this is what we chose to do (without any other therapies). He is now 12-1/2 and in “permanent” remission.

July 25, 2011 at 2:33 pm
(10) Googlegoof says:

Has anyone found the vaccine ONCEPT less than $550 per shot in the PA/MD area?

August 2, 2011 at 5:40 pm
(11) Jan says:

Tucker, age 11, had his four vaccine injections in June and July 2011 at the Virginia Maryland Regional College of Veterinary Medicine. The shots were around $270 each with added costs for the exams, the ultrasound and xray. He had no problems with the vaccine and he looks great. Hoping good things from this vaccine for all of us!

December 18, 2011 at 10:48 am
(12) enzo says:

My golden retriever is suspicious to have melanoma in his glottis, and tracheotomy might be required since difficulty of breathing might cause death during operation. If the exam result of biopsy confirms melanoma, the vaccine might be his last chance. However, it’s currently not available in Taiwan…….and the cost is really a burden to us!!!

January 11, 2012 at 5:02 pm
(13) debbie calvert says:

to robin, going thru similiar situation have many qts. Would like to hear info on you dog. We may go the same route, Please Help .

February 18, 2012 at 5:40 am
(14) Darah McGroarty says:

Dog death due to this oral melanoma vaccine: two board certified oncologists and two board certified internists stated the oral melanoma vaccine caused severe immune reaction and death in our dog. Be on alert! any reaction, including “mild” reactions need to be reported to the vet. A follow on vaccine shot should not be given after initial adverse reaction. Our dog died on 16 february 2012. Cost to try to save her: $20k and we are heartbroken. Merial will not alert about possible reactions!!! She was fighting to survive and the two Vet Specialty Oncologists and Internists all stated that this oral melanoma vaccine was the cause of her immune reaction and death. Her treatment to try to save her from the vaccine reaction is around $20k. Vets MUST alert owners to the fact that this vaccine like all vaccines may cause reactions and to be on guard for any changes including lethargy. Merial will be alerted to this death but I expect they will NOT include it within their data or change their “no side effects” marketing sentence. Be on guard that at least one dog has died from this oral melanoma vaccine and four board certified vets are aware of this.

November 19, 2012 at 11:02 pm
(15) Jacob says:

Melanoma vaccine does not work. Don’t waste your money.

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