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Featuring Demian Dressler, DVM and Sue Ettinger, DVM, Dip. ACVIM (Oncology), authors of The Dog Cancer Survival Guide

Palladia, First Dog Cancer Drug FDA Approved But Not Great

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

Leave a Comment





  1. lovewrinkles on October 24, 2009 at 1:46 pm

    My Shar-Pei (age unkwnown) is being treated with Masivet (since Sept 2nd) and for 2 weeks with chemo as well.
    However the MCT seem to be the same size. We live in Europe (the Netherlands) and are actually waiting for Palladia to be available here. We have been told maybe November?? Is Palladia the same drug as Masivet (by ab science, Paris) ??????

    • Dr. Dressler on October 25, 2009 at 8:03 am

      These are different drugs. Also, please remember that cessation of growth, in cancer medicine, is viewed (as unappetizing as it sounds) as successful treatment in many cases..
      Dr D

  2. Geralyn on August 29, 2009 at 9:24 am

    Our minature dachsund Maggie was diagnosed with MCT in Aug 08 with one lymph node positive. She was treated with Leukran,predinisone and benadryl. It worked for a while but eventually the tumor grew larger. She was started on Palladia mid July ’09 staged as grade III. In two weeks the tumor shrunk 80%. The drug caused some GI upset which resulted in it being stopped on certain days. The beginning of this month her appetite decreased. Aug 13th she had a bright red stool. We immediately brought her to her vet oncologist.Her platelets were 0. She continued to bleed out despite having two blood transfusions. We lost her on Aug.16th after 10 years of having her as a wonderful pet.

    • Dr. Dressler on August 30, 2009 at 9:10 am

      Geralyn, I am so sorry to hear this news. My thoughts are with you in this difficult time of departure. May your sadness soon be replaced with memories of your happy days together,
      Thinking of you,
      Dr D

      • Juliana on September 1, 2009 at 12:48 pm

        My 11-year old Dalmatian Luna was diagnosed with Mast Cell Disease in March. We are lucky to have a canine cancer specialist nearby, and she has access to Palladia. She explained that the application is relatively narrow, recommended for dogs who have not responded to standard chemo (vinblastine, etc), have multiple or recurrent tumors, but are still in Stage 2 (before it spreads to lymph nodes, bloodstream, etc). In that population, the success rate is closer to 60%. Luna is responding extremely well, even though there is evidence of the disease in her spleen. The tumors have all but disappeared in just a week, and she is completely symptom free. It may not just be Palladia, and it’s too soon to tell if there will be a recurrence, but this is absolutely an option for many dogs.

    • ShellyT on September 4, 2009 at 1:41 am

      Dr. D,
      Could you comment when Palladia might be a good idea/the only option? From what I’m reading on other sites, it works very well in specific situations, and I’ve heard from my vet too that you only use it after regular chemo doesn’t work. Maybe it shouldn’t be used in more advanced stages? We’re just starting down this road…one removed surgically a few months ago and a new one showed up just last week. I have a holistic vet, and even some of the herbal treatments are tough on the gi tract, and he’s already having trouble with presdnisone, so we have my dog on a bland home cooked diet already to keep it from irritation. I would like to know what you think in case the other treatments don’t work. Thank you.

  3. Sara on August 27, 2009 at 6:06 am

    So, after our vet consult I feel more confused…it sounds like Palladia has limited response (40%) and definite GI side effects. It is free still plus costs of blodwork etc, not that this is so important to me.

    On the other hand, it sounds like pred plus vin, or pred vin and ceenu, have much higher response and less side effects that affect quality of life. I am actually leaning more toward pred vin and maybe ceennu at this point, with palladia perhaps as a last ditch resource when those can no longer be used/if there’s no response.

    Radiation was also mentioned, to shrink the neck tumor. Although mitotic index in biopsy was 0, it’s grown noticeably in days from tennis ball to grapefruit size. Ugh. I think this will be outside our means financially and time-wise which stinks.

    The internist at least pointed out that there is not a huge variance in treatments—buying a few more weeks at times. That made me feel a tiny bit better. Still wish I could just cure it for him though. And I still feel terrible for not getting him in sooner—who knew a tiny bump could be such a problem?

    • Doug on September 15, 2009 at 3:52 am

      I have a Mastiff that developed a tumor on his front shoulder that was surgically removed early this year. It was diagnosed as a grade II mass cell tumor. In July he devolved another in his lymph gland in his armpit. My Vet sent me to a larger Animal Hospital here in Ill. that had a pilot Palladia program. He got in it and after 3-4 weeks the tumor had shrunk about 80%. I took him in last Thursday for a check-up and all tests game back great. CBC and all enzyme levels fine. Saturday he developed problems with his back legs(almost like lameness). Sunday he started bleeding out of his nose (Which increased by the hour) so I took him back to the hospital where he was admitted and Monday he was dead. . ..
      So this drug does have life taking side effects. Google it and you will see that lameness and bleeding are both there.
      The dog had cancer and was sick but I feel like I poisoned this dog to his death prematurely by giving him these pills for the last 4 weeks. If I could turn back the clock I would not have put him in the program. With no medication I would have had my friend around for maybe a year . Will miss him

  4. Sara on August 26, 2009 at 7:11 am

    Well, we’re just starting on this road. Our 4 year old beagle was diagnosed last week with a small MCT on his right side and another large one in his neck–the lymph gland and nodes. The vet feels that the multiple locations mean it has metastasized. He also feels it would be impossible to remove the neck ones with good margins and that is a lot of surgery to put our guy through for something with such high recurrence rates. They biopsied the neck and it was stage 2 with 0 mitations per 10 frames. The vet also feels with metastasis, radiation is not the best idea either.

    So, we’re exploring options. There is Palladia–we meet a specialist at 2 today to go over costs and treatment, side effects, and effects of this. We’re also consulting our vet about prednisone, possibly with ccnu and/or vinblastine.

    My concerns: I understand anything we do is likely just prolonging at this point, and quality of life is paramount to me. I want to prolong his happy being a dog lifestyle as long as we can, and so side effects etc concern me.

    We also have another dog and they are best friends/brothers, so I’m concerned about Palladia, Ceenu and Vinblastine since you’re supposed to handle with gloves, clean up urine and feces, etc–I’m not sure how to accomplish this with them sharing a yard and I don’t want to completely separate them at all times.

    Wish us luck, please. I’d appreciate it and so would my little guy, although I don’t think he realizes anything is wrong yet.

    • Juliana on September 16, 2009 at 4:09 am

      Hi Doug,
      I am so sorry about your boy. This is a nasty, unpredictable disease and you shouldn’t blame yourself. Luna nearly died from anaphylactic shock from the mast cells before we went to Palladia. She also had an armpit tumor, which is incredibly painful for them, so leaving it alone probably wasn’t an option for you. It was a last resort for us, as I’m sure it was for you. My vet is now saying that dogs may need to take a break from Palladia after a couple of weeks, but they’re really still figuring it out as they go. Luna is taking a break now after some dramatic weight loss and a really low white count, and I will definitely discuss your experience with our vet before we start up again. Thank you so much for sharing your story.

  5. Darryl on August 25, 2009 at 12:10 pm

    My 10 year old Jack Russel has been on Palladia for 2 weeks with amazing results, one tumor disappeared the others shrinking. Just heard today from the oncologist that Pfizer has not produced more since the first,they have 2 weeks supply, this is so disheartening and disappointing to hear this. We are all anxious to continue this treatment.

    • Danielle on September 29, 2009 at 3:21 pm

      My Benny, 13 year old lab, had a splenic hemangiosarcoma which spread to his omentum and abdominal cavity lining. We are starting treatment with Palladia today. He has two brothers who share the yard to relieve themselves. I have not seen any data or replies to this problem. This is a very important issue to multiple dog households who are experiencing this. If anyone has any answers I am sure there are a lot of readers who would be greatful. Nobody wants to endanger another dog if they can help it.

  6. Jane on August 22, 2009 at 4:27 pm

    My 7yr old yellow lab just had a Grade III MCT removed from his rib cage. My vet tells me he has two months if I don’t do anything.
    she has givn me an oncologist that will put him in the Palladia study.
    I have to wait until his stitches to come out and then talk about the next step of either radiation or chemo. He is so happy and healthy I just an’t believe this is happening. It seems diet of store bought dog food coud be to blame. He has had cronic ear infections(even in the winter with no beach)and tends to sneeze a lot. In hindsight he was allergic to his food.
    From now on he is eating eggs, cottage cheese, ground turkey,beef, chicken, yogurt and veggies.
    No more corn meal, or wheat products.

    • Donna on September 29, 2009 at 6:12 pm

      My Pepe is only 7 but has a nasty grade 2 tumor with a mitotic rate of 15 on his neck. Two surgeries, 3 weeks apart, have done no good because the tumor is back and bigger than ever (bigger than a grapefruit). He started on Lomustine, which seemed to help for the first treatment, but the cancer got smart for the second treatment and got bigger. Then we tried Vinblastine with the same response. First treatment helped, but the cancer got smart and just laughed at the second treatment. Good news is that it seems to be localized to just the neck/shoulder area with no spreading to lungs or internal organs. I’ve had him on Benadryl to control the histimine response and Prednisone to help control the size and tolerating those very well. He is starting on radiation Monday, but will start Palladia tomorrow. After reading some of the comments about Palladia, I’m scared to death he will bleed out. At this point, what are our choices, though? I’m not ready to let him go. This all just started in July and I’m floored at how much it’s advanced and the emotional torture I’ve already been through. This is my first real exposure to dealing with cancer in someone I love and it has been the most frustrating experience in my 42 years of existence. The pain I’ve suffered in my life doesn’t even compare to the helplessness and hopelessness this disease makes me feel. Yes, he is just a dog. But for someone with no human children, he is my pride and joy and if Palladia works, I suppose I’m willing to take the risk. For all those still fighting the fight, I wish you all the best and the wisdom to know when to let go. I only hope I’m strong enough when the time comes.

    • Donna on December 12, 2009 at 8:58 am

      Here is a link to a video that shows how to mix the cottage cheese and flax oil for anyone who is interested.

  7. KN on August 12, 2009 at 7:01 am

    An update on our Choc Lab taking Palladia: (my 1st post from Aug 1)
    After 1 week on Palladia our vet oncologist was surprised that his tumor has already shrunk. He is more comfortable and is eating (his tumor is in the back of his mouth-oral melanoma.
    Any extra ‘comfortable’ life we can gain is a + our dog is 13+ yrs old and has many fatty tumors in his chest.
    I will keep updating after our weekly checkup.

  8. Wayne on August 7, 2009 at 6:47 am

    I have a 6 year old doberman that had a tumor removed from his hock on 3/6/09. Biopsy was consistent with a grade 3 mast cell tumor with narrow margins and a mitotic index of 13 per 10 high power fields. Bottom line, not good. Since then, he’s been undergoing treament at the University of Georgia. He received treatment with the chemo drug vinblastine for 3 months…with no new tumors showing until the very end of the 3 months. He was then on the chemo drug CCNU, but had progressive disease after one dose. He then started Palladia on 6/29. Receiving the recommended dose, his tumors shrank remarkably fast. However, at the 1 week follow-up visit blood was detected on the fecal exam. Seems that internal bleeding — particularly in the stomach — is a common side-effect of the drug. As a matter of fact, some dogs died from the bleeding during the pre-approval drug trial. Anyway, his dose was reduced, and his tumors either stayed the same size, or shrank slightly. I noticed today, however, that one of the tumors is growing again. I’m not sure if this is the normal course of the drug (i.e. a temporary fix) or because he’s not on the recommended dose for his size. The oncologist has been very concerned about bleeding because of the high occurence during the drug trial, so this lower dose may be partially ineffectual. Mast cell cancer is a nasty disease, and my dog is perfectly healthy, active and happy only because it hasn’t yet progressed beyond the hock. I’d love to think that the appropriate dosage of Palladia will get him back on track, but based on everything I’m reading it appears that this effort is only prolonging his life briefly. This is my first dog to have cancer, and it’s devastating for me.

    • Donna on December 12, 2009 at 8:49 am

      Update on Pepe.

      Pepe started taking Masitinib (Kinavet, the European approved drug sent from Paris) on the 3rd of this month and is doing well. I’ve learned a few things about this drug in the past 9 days and, if anyone is considering tring this, I hope this information helps you decide.

      First, a little background. Pepe was diagnosed with a grade 2 MCT in July on his left prescapular area. The tumor was remove right away, but the tumor came back with a vengeance. I immediately brought him to an oncologist who scheduled him for a second surgery. Because the tumor had such a quick recurrence, he was started on Lomustine the day after the second removal.

      On 9/16, Pepe’s oncologist determined the Lomustine was no longer effective and switched him to Vinblastine and put him on Prednisone. I was also giving him Marin and SamE to help protect his liver. I ended up stopping the SamE because the Marin alone was doing a good job and the fewer pills to give him the better.

      Pepe’s treatment stayed the same until 9/29 when it became clear the Vinblastine was no longer working. It was 9/30 when he started on Palladia and 10/5 that he had his first radiation treatment. In the meantime, I was researching like crazy for natural treatments and remedies and found some information on cottage cheese and flax oil by Dr. Johanna Budwig of Germany. It seemed strange, but her theory was that if you whip the cottage cheese and flax oil together, the flax oil would become more highly absorbable into the system and would more quickly restore missing electrons in the body. I mention this now because it will be more relevant a little later in this post. Anyway, I tried this emulsion with Pepe and it didn’t seem to help so I stopped it, but did not forget about it.

      Pepe had a total of 4 radiation treatments, but was taken off Palladia for two weeks due to diahrrea. During that time, the tumor spread to his neck, but we would not realize it until 11/3. That was such a heart-crusher. I should also mention that I have been giving Pepe Omega fatty acids and multivitamins to help him recover and protect him as much as possible from all the drugs taking such a toll on his body. But, he’s been bright and happy and surprisingly energetic most of the time and doing very well. Don’t get me wrong, he’s had some really bad days in this process, but overall he’s been a real fighter and when I see him run and play, it’s all worth it.

      On 11/11, Navelbine was added to his treatment, which helped for about two weeks then Asparaginase was added with his third treatment. That combo seemed to help a little, too, but the tumors just refuse to get smaller, they pretty much stay the same size now.

      This brings me to Masitinib (Kinavet) and some of Dr. Dressler’s treatments mentioned in his book.

      As I mentioned earlier, the Masitinib has been tolerated very well, better than Palladia and seems to have really slowed the progression of the tumors, which Palladia stopped doing without the radiation to help it. Make sure your dog has an empty stomach when administering this Kinavet. Pepe sometimes doesn’t finish his dinner so I make sure his food is available through the night if he gets hungry. Big mistake. He vomited about an hour after I gave him the Kinavet and up came the food he was snacking on. Kinavet also seems to increase his thirst a bit and gives him a some soft stool, but nothing that can’t be managed.

      The interesting thing is that, although the tumors are not shrinking, Pepe is in less pain and has more mobility. He hasn’t needed painkillers for 4 days now and he ran like the wind when I took him out yesterday. He was so happy it just warmed my heart and made me feel like everything was going to be ok. He has been struggling with a little fluid buildup, but we are managing it with lots of massage.

      I also want to mention that I started Pepe on a combo of soy lecithin and curcumin about a month ago and Lutimax about 5 days ago. I don’t know that the lecitin/curcumin was working because it was such a mess to mix it, I just started poking holes in the lecithin gelcaps and giving him the curcumin capsules with it hoping they would dissolve together in his belly. But a few days ago I had an idea that I thought would work to make it easier to administer it and this is where Dr. Budwig’s concoction has become really important.

      I took her mixture of cottage cheese and flax oil, added two teaspoons of Lutimax, added two gelcaps (poked and squeezed in) and added the powder of six capsules of curcumin and whipped it up until it turned into the mousse-like texture it’s supposed to be. If I understand Dr. Budwig’s intention clearly, this mixture is an awesome delivery system and should only compliment the affects of the Kinavet. I’ve given this super-concoction to Pepe for two days now, and I think it’s helping. It certain is not making him worse and I’m hoping that a little more time will yield the results I’m looking for. I am also giving him two teaspoons of Lutimax powder dissolved in water each day along with two capsules of Lutimax each day. Oh, I almost forgot the K-9 immuntiy and Transfer factors. Pepe has been on these the whole time.

      I realize this is long, but I really hope that Pepe’s experience can help other dog parents out there.

      I would also like to tell Dr. Dressler that I’m still reading the book, but it has helped me so much so far and I’m truly grateful to have such a comprehensive guide to help me.

      • Dr. Dressler on December 13, 2009 at 11:21 pm

        Thanks for your contribution!
        Dr D

  9. Elizabeth on August 3, 2009 at 8:00 am

    Can anyone tell me more about CoQ10 and using it for dogs with tumors?

    • Michele on October 1, 2009 at 12:59 am

      My Rosie is a 9-year-old yellow lab. We don’t know her exact age because she was adopted. She was diagnosed with a grade 2 Mast Cell Tumor in June ’09 on her lower stomach, which was surgically removed and had a recurrence in the same location in August ’09 that was also grade 2 but with a mitotic index of 20. It had spread to her lymph nodes and surrounding tissue. Both the 2nd tumor and lymph node were also surgically removed but the lab tests showed they did not get all the cancer. We took Rosie to an oncologist who started her on Palladia 6-weeks ago along with 3 medicines to protect her stomach, as well as diarrhea medicine. After about a week they stopped the Palladia for a few days because of diarrhea. We added the diarrhea medicine and the oncologist reduced the Palladia dosage. That allowed Rosie to finish the 6-week course of Palladia. We just received the results this week, and all tests, bloodwork, kidney tests, x-rays, ultrasound, physical examination all came back as normal…No sign of cancer. I have read many horror stories…but I wanted to share Rosie’s story to let people know that not all cases end badly. There is hope. I have documented Rosie’s experience this past 6 weeks in her dog blog at http://rosiesroad.wordpress.com.

  10. KN on August 1, 2009 at 5:47 pm

    We just started our 13 yr old choc lab on Palladia. He has had 2 oral melanoma tumors removed and has been taking the oral melanoma vaccine as well as ‘el-gen’ (experimental), dha, and tagamet. The vaccine has kept the cancer from spreading, but his oral tumor has returned yet again and now his lymph node is enlarged on that side.
    We went to our canine oncologist and he suggested Palladia. He was pushing the radiation, but we didn’t think our dog could handle general anesthesia 2x week for at least 4 weeks. He is old and has large ‘fatty’ tumors in his chest. He has difficulty walking and standing, plus the discomfort after.
    We’re hoping the Palladia will work. Since it is a trial – the drug is ‘free’ but we need to pay for weekly bloodtests for 6 weeks – then every 6 weeks for however long we keep him on it.
    Anyone that has had a dog with cancer knows the costs are astronomical. We have spent close to $8,000 already this year. Our local vet is great – trying to keep costs down and being realistic since our dog is old. The oncologist, however, tends to make us feel guilty if we don’t just pay whatever it takes to keep him going. There aren’t a lot of canine oncologists though.
    I need to call Pfizer though – we have another dog and there are very ‘strong’ warnings about humans coming in contact with urine, feces or vomit from dogs taking Palladia – but no warnings about other animals. It would be impossible to keep the 2 apart. I would be heartbroken if our other dog got sick from his friend’s treatment.

    • Teresa on October 1, 2009 at 3:46 am

      I am more confused than ever. Sy, my 11 1/2 yr ols Chessy was diagnosed with 7 grade II and III tumorse on 8-25-09. All were removed with some margins clear. I immediatley brought him to the U of Iowa to begin the Palladia treatment. Initial wk brought some adverse reactions. The second week showed diminished reactions. The third week he showed signs of being slightly anemic as well as discoloration in the nose. Therefore he was removed from the meds for two weeks. Today he will get CBC, serum and urinalysis to determine whether we can restart the med. After reading this blog I do not know what to do with him. There has been no regrowth that I can find and he seems to be holding his own but I want every day I can have with him while he maintains a good quality of life. He is being treated traditionally and holistically and I think it is going well but if the palladia is going to kill him sooner what am I to do??? There does not seem to be a great consensus about what is good. I have not heard about the 6wk dosing. My understanding was he would be on the meds for the remainder of his life or until there was evidence of the return of the mast cell tumors. I can’t think straight anymore…

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