Palladia, First Dog Cancer Drug FDA Approved But Not Great
Dr. Demian Dressler is internationally recognized as “the dog cancer vet” because of his innovations in the field of dog cancer management, and the popularity of his blog here at Dog Cancer Blog. The owner of South Shore Veterinary Care, a full-service veterinary hospital in Maui, Hawaii, Dr. Dressler studied Animal Physiology and received a Bachelor of Science degree from the University of California at Davis before earning his Doctorate in Veterinary Medicine from Cornell University. After practicing at Killewald Animal Hospital in Amherst, New York, he returned to his home state, Hawaii, to practice at the East Honolulu Pet Hospital before heading home to Maui to open his own hospital. Dr. Dressler consults both dog lovers and veterinary professionals, and is sought after as a speaker on topics ranging from the links between lifestyle choices and disease, nutrition and cancer, and animal ethics. His television appearances include “Ask the Vet” segments on local news programs. He is the author of The Dog Cancer Survival Guide: Full Spectrum Treatments to Optimize Your Dog’s Life Quality and Longevity. He is a member of the American Veterinary Medical Association, the Hawaii Veterinary Medical Association, the American Association of Avian Veterinarians, the National Animal Supplement Council and CORE (Comparative Orthopedic Research Evaluation). He is also an advisory board member for Pacific Primate Sanctuary.
Updated: March 14th, 2019
Palladia, the first drug officially approved for use in treating dog cancer has arrived. This was described in the Dog Cancer Survival Guide by it’s pre-market name, SU11654. Now it’s finally ready for release.
Palladia, made by Pfizer, has been approved by the FDA. It is expected to be available next year. This drug is approved for treating mast cell tumors in the dog.
The fact that this is the first drug approved for dog cancer may be odd for many. What about all those chemotherapy drugs that are used? They are not FDA approved?
Well, the facts are that vets and veterinary oncologists have been using human drugs the whole time. As a matter of fact, many of the drugs we use generally are not FDA-approved for use in the canine.
Why?
It turns out that FDA drug approval is allowed for one species at a time. On top of that, approval is for one disease or problem. In veterinary medicine, we have cats, dogs, birds, rabbits, monkeys, snakes, and so on…many different species, and they all need treatment.
It would take hundred of years and staggering amounts of money to get all our drugs approved for all these different species and diseases.
So vets have “off-label” drug use privileges. Off-label drug use means we can use drugs approved for one species (including humans) freely in other species.
Let’s take a look at some of the facts around Palladia.
Like most of the conventional treatments we use in treating dogs with cancer, the numbers for Palladia are a bit disheartening.
The median duration of objective response (meaning how long the Palladia’s effect lasted on mast cell tumors) was 12 weeks. Yes, 3 months of tumor shrinkage or disappearance is what you can expect. This number is taken from the original study.
After 3 months the cancer came back.
On top of this, not all dogs with mast cell tumors even responded. It turns out that roughly 40% of dog with mast cell tumors will actually respond to the drug, while the majority do not.
This means that while about 40% of the time the cancer either went away or shrank, in the remaining 60% of dogs Palladia had no effect.
Get a copy of the Dog Cancer Survival Guide for more information and tools to help your dog with cancer
Sigh.
If you would like to look at the original data for yourself, here is the link.
This highlights important points.
First, there is a big to do about Palladia. But, the actual statistics are depressing. Interesting contrast between hype and reality.
Second, I think most guardians of dogs afflicted with mast cell tumors would not be jumping for joy at these numbers, in spite of the festivities at Pfizer.
Lastly, this shows how important it is to leap sideways in our efforts to really treat canine cancer.
The more I think about dog cancer, and disease in general, the more I believe early choices are key, long before old age.
I will start addressing how dog cancer does not start in old age, in future posts. Instead, it starts many, many years before hand. We need to start taking steps earlier, much earlier.
Best to all,
Dr D
Dr. Demian Dressler is internationally recognized as “the dog cancer vet” because of his innovations in the field of dog cancer management, and the popularity of his blog here at Dog Cancer Blog. The owner of South Shore Veterinary Care, a full-service veterinary hospital in Maui, Hawaii, Dr. Dressler studied Animal Physiology and received a Bachelor of Science degree from the University of California at Davis before earning his Doctorate in Veterinary Medicine from Cornell University. After practicing at Killewald Animal Hospital in Amherst, New York, he returned to his home state, Hawaii, to practice at the East Honolulu Pet Hospital before heading home to Maui to open his own hospital. Dr. Dressler consults both dog lovers and veterinary professionals, and is sought after as a speaker on topics ranging from the links between lifestyle choices and disease, nutrition and cancer, and animal ethics. His television appearances include “Ask the Vet” segments on local news programs. He is the author of The Dog Cancer Survival Guide: Full Spectrum Treatments to Optimize Your Dog’s Life Quality and Longevity. He is a member of the American Veterinary Medical Association, the Hawaii Veterinary Medical Association, the American Association of Avian Veterinarians, the National Animal Supplement Council and CORE (Comparative Orthopedic Research Evaluation). He is also an advisory board member for Pacific Primate Sanctuary.
Do we know what the cost of PALLADIA will be when released in 2010?
Well…40% isn’t the greatest,and I’ve heard that a bottle of a human cancer drug..Sulusin,I think it was called..sold for a bottle of 50,000 dollars just for 25 pills. I have read articles about how cabbage and kale help fight cancer in humans,and we are currently trying it on our dog,mixed with can dog food.(the dry stuff seemed to lack in protein.)..So far he is urinating better,but he now has a cough because his lymph modes in his neck are swollen.I’ll try to keep posting on his progress..who knows..maybe it’ll work. I know I’m not paying out thousands of dollars for chemotherapy,just to have the doctor say..”Well,there’s only a 30% chance it’ll work.”
I would like to make a clarification on my previous comment. Rosie’s Palladia treatment does not stop at 6 weeks. It will continue for the rest of her life, as long as she does not experience any of the side effects.
When we started on Palladia, I was not looking that far ahead. I was just concentrating on day to day and week to week. My goal was for Rosie to stay on the Palladia for the initial six weeks because that was when the oncologist would do the additional tests and ultrasound to see if the Palladia was working. Thankfully, in Rosie’s case it worked in the first six weeks. All tests came back normal. However, Rosie continues to take Palladia. There is a risk because the long-term effects are not known. However, I’m glad we made this decision because at this time Rosie is doing great. To read more about Rosie’s experience, go to her dog blog: http://rosiesroad.wordpress.com.
Experimental Therapeutics, Preclinical Pharmacology
Phase I Dose-Escalating Study of SU11654, a Small Molecule Receptor Tyrosine Kinase Inhibitor, in Dogs with Spontaneous Malignancies1 ,2
Cheryl A. London3, Alison L. Hannah, Regina Zadovoskaya, May B. Chien, Cynthia Kollias-Baker, Mona Rosenberg, Sue Downing, Gerald Post, Joseph Boucher, Narmada Shenoy, Dirk B. Mendel, Gerald McMahon and Julie M. Cherrington
School of Veterinary Medicine, University of California, Davis, Davis, California 95616 [C. A. L., R. Z., M. B. C., C. K-B.]; Veterinary Cancer Referral Group, Los Angeles, California [M. R., S. D.]; Veterinary Cancer Referral Group, New York, New York [G. P.]; SUGEN, Inc., South San Francisco, California [A. L. H., N. S., D. B. M., G. M., J. M. C.]; and Pharmacia Animal Health, Kalamazoo, Michigan [J. B.]
Purpose: The purpose of the following study was to investigate the safety and efficacy of the novel multitargeted indolinone receptor tyrosine kinase (RTK) inhibitor, SU11654, using a canine model of spontaneous tumors. This p.o. bioavailable compound exhibits potent inhibitory activity against members of the split kinase family of RTKs, including vascular endothelial growth factor receptor, platelet-derived growth factor receptor, Kit, and Flt-3, resulting in both direct antitumor and antiangiogenic activity.
Experimental Design: This was a Phase I trial in which successive cohorts of dogs with spontaneous tumors that had failed standard treatment regimens received escalating doses of SU11654 as oral therapy. Pharmacokinetics, toxicity, and tumor response were assessed.
Results: Fifty-seven dogs with a variety of cancers were enrolled; of these, 10 experienced progressive disease within the first 3 weeks. Measurable objective responses were observed in 16 dogs (including 6 complete responses), primarily in mast cell tumors (n = 11), mixed mammary carcinomas (n = 2), soft tissue sarcomas (n = 2), and multiple myeloma (n = 1), for an overall response rate of 28% (16 of 57). Stable disease of sufficient duration to be considered clinically meaningful (>10 weeks) was seen in an additional 15 dogs, for a resultant overall biological activity of 54% (31 of 57).
Conclusions: This study provides the first evidence that p.o. administered kinase inhibitors can exhibit activity against a variety of spontaneous malignancies. Given the similarities of canine and human cancers with regard to tumor biology and the presence of analogous RTK dysregulation, it is likely that such agents will demonstrate comparable antineoplastic activity in people.
This article has been cited by other articles:
C. A. London, P. B. Malpas, S. L. Wood-Follis, J. F. Boucher, A. W. Rusk, M. P. Rosenberg, C. J. Henry, K. L. Mitchener, M. K. Klein, J. G. Hintermeister, et al.
Multi-center, Placebo-controlled, Double-blind, Randomized Study of Oral Toceranib Phosphate (SU11654), a Receptor Tyrosine Kinase Inhibitor, for the Treatment of Dogs with Recurrent (Either Local or Distant) Mast Cell Tumor Following Surgical Excision
Clin. Cancer Res., June 1, 2009; 15(11): 3856 – 3865.
[Abstract] [Full Text] [PDF]
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C. Khanna and I. Gordon
Catching Cancer by the Tail: New Perspectives on the Use of Kinase Inhibitors
Clin. Cancer Res., June 1, 2009; 15(11): 3645 – 3647.
[Abstract] [Full Text] [PDF]
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S. Letard, Y. Yang, K. Hanssens, F. Palmerini, P. S. Leventhal, S. Guery, A. Moussy, J.-P. Kinet, O. Hermine, and P. Dubreuil
Gain-of-Function Mutations in the Extracellular Domain of KIT Are Common in Canine Mast Cell Tumors
Mol. Cancer Res., July 1, 2008; 6(7): 1137 – 1145.
[Abstract] [Full Text] [PDF]
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A. Rusk, E. Cozzi, M. Stebbins, D. Vail, J. Graham, V. Valli, J. Henkin, R. Sharpee, and C. Khanna
Cooperative Activity of Cytotoxic Chemotherapy with Antiangiogenic Thrombospondin-I Peptides, ABT-526 in Pet Dogs with Relapsed Lymphoma
Clin. Cancer Res., December 15, 2006; 12(24): 7456 – 7464.
[Abstract] [Full Text] [PDF]
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J. M. Cherrington
Taking Biological Targeted Agents into Clinical Trial
Am. Assoc. Cancer Res. Educ. Book, April 1, 2005; 2005(1): 23 – 29.
[Full Text] [PDF]
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Thank you Dr. Vetro, for your comment. Nice to see the MD’s are tuning in 🙂
Dr D
My little girl Ellie was recently diagnosed with a mast cell tumor on her butt near her anal area. It is not well defined and surgery will not get enough margins. Radiation is financially out of the question and chemotherapy is expensive as well. I would try chemotherapy but I am just making it financially. Through our oncologist we tried a new method involving Vitamin D in a study at a university near us. Her calcium levels shot up and she needed to be hospitalized for 3 days with fluids and other medicine she was on to begin with. She was very ill. We decided not to continue this treatment. One of our vets told us about Pallaidia. Our oncologist told me today that it will be available to oncologists only in July. Our regular vet will not be able to get it. You might like to check with your oncologist to see if they can get it. It may be much less expensive then other chemotherapy medications. Donna
Hi Sara and KN: My Doberman will soon be starting Palladia. You had expressed concerns about the effect of that drug on your other dogs. Have you received any comforting information from good sources? I have the exact same concern for my second dog who seems quite healthy and devoted to my girl who will undergo treatment. They sleep together, play with the same toys and drink from the same water bowels. I would be grateful if you can share any information with me.
Palladia not great? Why are you so disappointed with those numbers, “roughly 40% of dog with mast cell tumors will actually respond to the drug”. If this were a human drug it would be hailed as a breakthrough with those kinds of statistics. Just like in Humans, every dog will respond different to the drug. The fact that it has the potential to cure 40% of the time makes it a great choice. I would also be willing to bet when used after surgery (adjuvant), those numbers would go up. I lost my 14year old Sheppard to Mast Cell; I only wish this would have been an option for her. You should be supporting the drug not chastising it.
Karl,
“Response” does not equal “cure”, sorry to say. The growths either shrank or disappeared, only to come back roughly 3 months later. Percent cure? Zero. I stand by the title.
D
i found out a few weeks ago that my sweet, 14.5 year old shih tzu has thyroid cancer. after a visit to the uw veterinary teaching hospital, we found out it has spread to his lungs. pure devastation! they don’t recommend radiation after the cancer spreads. traditional chemo was presented as an option, but with only 20 % chance of working and lots of yucky side effects (and $3000). they offered palladia (free!) and metacam, a non-steroid anti-inflammatory pain relief. he’s been on this a week now, switching one day palladia, one day metacam. he had a tiny bit of blood in his stool 1st day on palladia, nothing else since. he does still seem lethargic and not much appetite (but he was worse before diagnosis and drugs), but he does have good moments, walking outside and playing/chewing a toy at night after he finally eats. we will see early november on a chest xray the effects(or not) on the tumors. i pray it helps, even if temporarily.
had not heard about the bleeding on palladia, yikes! we were told that statistically some dogs can die on palladia. but, were also told our dog would be gone in 2 months with no treatment. so we are taking the chance.
my heart goes out to everyone on this site. our precious dogs should not have to suffer!
I think people should try to stay with evidence base medicine (conventional) and use alternative medicine as an adjuctive treatment or last resort.
our Rosie has MCT,after three ops,they still returned.
We put her on a diet of cottage cheese and Flax oil,
we also give her C-caps from Petalive .com. We have just
returned from the vet and he cannot explain the turn around.
Incidentaly she is still taking the precribed stroids supplied by the
vet. The vet said whatever we are doing carry on,its working.
Have been fighting mast cell tumor in the lymph node located in the neck for about 10 months now. Have gone the current route of surgery and radiation. I have not done chemo, although this has been suggested. Tommy is doing well, but it’s an hourly concern. What will happen next?? Currently we work with an oncologist a primary vet and a holistic vet. I wish this drug had a better result. Also, if the drug is not available now,, will my Tommy make it to the time limit for it to be tried.margaret
What if you coupled surgery for mast cells tumors witha a follow-up of Pallaidia. My yellow lab, had 3rd stage mast cell CA, in her chest area. The tumor was removed and supposedly well encapsulated. 6 months later another errupted to the adjacent site. 3 months later another errupted again to the adjacent site. After 6 operations supplements antioxident food. 17 months later the tumor came right back to where it started plus another near her rectal area. Her final surgery she came home to me throwing up for 15 days, a temporary fix for this was Protonix. 2 weeks before her final surgery she had started Arteomicin..We will never know what went wrong.. Stopped the Arteomicin after the surgery.. All the tumors were well encapsulated..
My girl was strong healty right till the end. Kidneys, liver,excellent.. She started to fluid bloat.Lasix keep her going another 2 weeks.. However it appears that these tumors once removed are still stemming in the bloodstream. What if you have the tumor removed with a follow-up of Palladia.Has that ever been considered ?
Use high levels of vit C IV asap, the best! You will not believe your eyes! Toto, my 12 year old toy poodle, with aggressive oral melanoma takes injections very well, he is joyful, playful, has a good appetite, full of life again, I did not see him like this for quite some time! He is getting 3g 3 times a week (he is 17lb) plus acetyl dglucosamine by IM plus fish oil in the mooring and IP6 twice a day. It was only because I got tired to feel his lymph nodes being enlarged I added doxycycline (IV also, he can not take it orally, even with food, his stomach is too sensitive).
This is interesting because I thought I read as recently as a few days ago a man who wrote into your blog and said his dog responded well to chemo, radiation etc… and was doing well. Then 3 weeks on Pallaidia and his dog was dead. Is there something we don’t know? Like other new drugs I would hesitate to use one of my dogs as a guinea pig when a drug first comes out.
Our Beloved dog Nelly has M.C.T. grade 3 she was given 30 days to live over one year ago with 17 rounds of chemo bumps sill were coming up. She has so many on her removing them or radiation was not an option. We started her on Palladia June 10th we are very happy with the results so far since Nelly has been on it no new bumps! all bumps are dying. Any pet owner who is going thru this nightmare I tip my hat to you this is the worst thing that could happen to our beloved kids.