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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. Alli B. on August 15, 2012 at 9:56 am

    Dr. D: My 12 year old dog has osteosarcoma in rear leg. Large mass on tibia. Biopsy confirmed osteosarcoma. Chest x-rays show 4-5 mets in lungs. We have decided not to amputate at this time and treat bone pain with injections, patch and oral meds. Our oncologist suggested Palladia. Confused after researching it on internet. Do you think the 40% response rate decreases b/c the visible cancer in the lungs? Most concerned with our baby’s quality of life. Have you heard of much success for osteosarcoma? Thank you. Alli.

    • Kirk M on October 11, 2012 at 9:05 am

      Our 8 year old Chocolate Lab has been diagnosed with Neuroendocrine Carcinoma. We are still doing some testing to find exactly which organs liver and pancreas are affected and if surgery is an option. We are going to start her on Palladia in the coming days. I am new to all of the terminology, but have you had any experience or knowledge of how Palladia reacts to the Neuroendocrine Carcinoma?

  2. Maggie on August 10, 2012 at 5:16 am

    I have two dogs who have both had cancer this year. My little terrier x had a spindle cell carcinoma removed in jan,followed by radiation and chemo. She had her 3 month check yesterday and so far all clear. My other dog, a GS, Collie, Retreiver x has so far had 3 cancers this year. He was diagnosed with masses in both lungs in January. He has had every test Imaginable but they were unable to get a diagnosis as they could not reach the tumours. Since (9 weeks ago and 3 weeks ago respectively) he has had a hepatoid tumour and anal sac carcinoma,both removed surgically. The anal sac tumour was very small. His lung and Anal tumours were both discovered by accident. His oncologist has Recommended Palladia, 3 times a week, 80 mgs.

    I will post how he gets on. He will be having a review in 6 weeks.

    • Al Vasconcellos on October 29, 2012 at 4:50 am

      Dear Dr. Dressler,
      We at InCytu have been thinking about applying our immuntherapy in the veterinary field. Could you recommend any journal articles that might help us understand the demands of the patient population and aide us in choosing a first indication?

      Thank you,
      Al

  3. Lindsey on August 9, 2012 at 2:05 pm

    Hi,

    My 15 year old cockapoo was recently diagnosed with lung cancer. He has two tumors on his lungs that the oncologist believes are primary cancer. Junior had a soft cell sarcoma on his leg removed a little over a year ago and they were unable to get clean margins however he did receive several radiation treatments after the fact. Because of Junior’s age I don’t think surgery is a realistic option at this point but the oncologist did suggest trying Palladia. I am a little worried after reading some of the side effects because Junior also had an auto immune disease 6 years ago and currently has cushings and I don’t know if the Palladia is safe with his auto immune disease. Does anyone have any experience in using Palladia to treat lung cancer? Thanks in advance for any advice or help,

    Lindsey

    • jody orso on November 6, 2012 at 3:07 pm

      My dog tiffany has been fighting mast cell for about 5 months now. She takes benadryl prednisone and pepsin every day. We were doing vinblastine which shrunk the tumors but then stopped working. We switched to palladia, which she had a horrible reaction to after 1 treatment, vomiting bloody stools and lameness
      I almost lost her. We are now going to try masitinib and praying it works without the horrible side effects. Love her more them anything in the world and when she is having a good day its hard to believe she’s sick. If she gets sick from this I’m going to stop torturing her. My other dog has lymphoma and is doing awesome.All these drugs are a fortune if you have a costco nearby have your vet give you scripts they get all these dogs drugs for a LOT less. My vet charged me 350 for 1 pill costco gave me 4 of the same pill for less. If you call them they can get almost anything they order for you and the pharmacist has been awesome

  4. Ian S on August 4, 2012 at 11:25 am

    Our 13 y.o. Kerry Blue terrier was diagnosed with nasal carcinoma at the beginning of February 2012 following a couple of serious nose bleeds. This was only one month after he was diagnosed with renal insufficiency and put on a prescription diet for his kidneys. Our oncological vet offered options of palliative care (including pyroxicam), radiation, or Palladia which has shown some promise for the treatment of this cancer. While radiation is known to extend life for this type of cancer, we did not feel that the drawbacks were acceptable considering our pet’s condition and age. At the suggestion of our vet, we opted to try Palladia. Initially, we had trouble settling on a dose that our dog could tolerate but once we did, he appears to have responded quite well. Recently, he began to reject the kidney diet kibble and started to lose weight. However, we began adding a little low sodium broth to the kibble and he is now eating well and regaining his weight. His kidney function remains stable and there are no signs of the nasal tumor growing. Indeed, six months in, bloody seepage from the nose has all but stopped and he has all his old energy back. I should also say he is on yunan biayo to reduce potential bleeding.

    • dadude on November 26, 2012 at 12:32 pm

      We have an 8yo Maltese, diagnosed with a Mast Cell Tumor a few weeks ago by fine needle aspirate by our local vet. The growth is complicated by location being just above the main pad on the right front paw. No other location/metastisis involved thus far. We were referred to both surgical and oncologic specialists, the surgeon performed a punch biopsy and blood work, results confirming Stage 2/3 MCT. The oncologist & surgeon indicated excision to a clean margin in this location was virtually impossible without amputation, and this would create other complications and not recommended due to the aggressive nature/grade of tumor and quality of life tradeoff. Between initial diagnosis and first visit with oncologist, the tumor had become ulcerated (likely aggravated by aspiration and biopsy), was growing rapidly and getting worse. After review of traditional options (amputation, chemo, radiation), Palladia was considered and eventually prescribed, along with steroid (predinsone) & Benydryl to alleviate pain/swelling. It should be noted vets indicated the dog may have symptoms of Cushings disease as well.
      Results of treatment have been excellent thus far (approximately 4 weeks since initial diagnosis). After approximately 1 1/2 weeks of treatment, ulceration resolved, the tumor has shrunk and skin healed, Benydryl was discontinued. Follow up evaluation and blood work last week has revealed elevated blood sugar and liver enzymes. Hormone therapy was reduced (from every day to alternating days).
      As we are early on this path, but encouraged by this pill treatment of a fatal disease, a lot of questions still come to mind.
      1. Could the elevated blood sugar/enzymes be affected/result of interaction with Cushings?
      2. Readings indicate Palladia typically prescribed as a post-operative treatment following tumor excision. Though surgery is not a viable option in this case, is it’s use as a primary treatment simply the best of the worst possible treatments?
      3. So far our dog has had relatively minor side affects, voracious appetite (more than typical but likely a result of hormone therapy), restive/restless cycles, possible mild GI distress (only 1 time), so overall very pleased with results thus far, but is there a possible build up of intolerance to this treatment regimen and should we be steeling ourselves for a remission/recurrence cycle?
      4. Does the discontinuance of treatment (if we ever get to remission) open the door to the possibility of a future metastisis, as so far the disease has only been local affected the paw or is this a rest of life treatment?
      5. Is there possibility the treatment could resolve to the point surgical treatment could become a feasible without amputation?
      We’re reading up and encouraged, but waiting for the other shoe to drop, thanks in advance for any feedback.

  5. Renee on August 1, 2012 at 3:22 pm

    Thank you Dr. D! Yes, we did the staining. I am following your suggestions from the book , which I can’t read fast enough. My oncologist and holistic vet were on board with probiotics and basically everything you talked about in your book. I will check out the links you attached. Palladia, as I understand from the oncologist, is suppose to turn-off the mutation of the cancer in the cell and hopefully by doing this we can achieve some sort of remission. I know this is a rare cancer, but any other info that you or Dr. Sue can provide me would be greatly appreciated!

    Many thanks! Renee

  6. Renee on August 1, 2012 at 12:07 pm

    My 11yro Corgi mix was diagnosed with an intestinal GIST. The oncologist told us our options. The medicinal option was Palladia. After speaking with them today, they said most dogs, as you have also mentioned, tolerate this drug well. We will be starting after we finish our Doxycycline. How well have you seen it work with GIST? Is there something else we need to look at before starting? I am slowly integrating your cancer diet. He has a sensitive tummy and he is a bit of a picky eater. But we will continue on and hope for the best!

    many thanks! Renee

    • Dr. Demian Dressler on August 1, 2012 at 1:28 pm

      Dear Renee,
      I assume there was a biopsy that allowed the diagnosis with c-kit+ staining…this would provide some basis for the use of Palladia. I am not aware of data for Palladia with GIST but it likely will be coming in the future. The choice is theoretical based on how this drug works with certain cancer cell types that have specific signalling mutations. Its new stuff both in terms of understanding GIST and also Palladia.
      I would also read the following:
      https://www.dogcancerblog.com/blog/an-overview-of-what-else-can-i-do/
      Definitely consider apocaps under veterinary supervision containing curcumin among other things:
      https://www.dogcancerblog.com/blog/spice-of-life-curcumin-and-dog-cancer/
      Ginsing is another thought:
      https://www.dogcancerblog.com/blog/ginseng-a-common-chinese-herb-for-dog-cancer/
      Probiotics might be nice too (low priority here)
      Might be a good time to read the Guide if you have not yet done it…hope this helps
      D

      • Amy Kennedy on November 29, 2012 at 2:42 pm

        Hi i have a 7 yr old golden and she was just recently (4 days ago) diagnosed with a sqaumous cell carcoma up in her upper jaw. we are considering surgery depending on what the CT scan shows but our only other option is Palladia . We have been told it can shrink these type of tumours and get us good results have you heard much of this??

        • Dr. Demian Dressler on December 26, 2012 at 12:25 pm

          Dear Amy,
          yes, Palladia is being used with this cancer type now. However, you may also want to educate yourself on some of the other things that can be done for a dog with cancer. Here’s a post for you to read:
          https://www.dogcancerblog.com/blog/an-overview-of-what-else-can-i-do/
          Best, Dr D

        • Dr. Susan Ettinger on December 29, 2012 at 5:52 pm

          Hi Amy,
          Surgery is definitely the treatment of choice for oral squamous cell carcinoma (SCC). If surgery is not an option, radiation can be considered, and is recommend if surgical margins are not clean. Palladia is an alternative option. In my opinion, I recommend surgery or radiation first over Palladia for oral SCC. Something to consider, but limited data showing efficacy.
          All my best, Dr Sue

    • Dr. Susan Ettinger on August 10, 2012 at 9:51 am

      Hi Renee,
      Yes I know of responses, but data is limited becauase GIST are uncommon. But many GIST have the c-kit mutation that Palladia targets. Under good supervision of an oncologist, most dogs tolerate Palladia, even with a sensitive stomach. I like to add a probiotic in these cases.
      All my best, Dr Sue

    • William Carter on December 17, 2012 at 11:02 am

      Fyi. I have a dog with mast cell tumor grade 3 and has been in remission for 3 years on pallidia

  7. Debra on July 27, 2012 at 7:50 am

    Hi JV

    I am really sorry to hear about your Jack Russell. I too have a Jack Russell. Oreo is 14 years old and was just diagnosed this week with MCT. Did you start the Palladia treatment? I am stuck between buying her a little more time (according to the studies) and the quality of what remains of her life. Surgery is not a recommended option at this point and we have her on benydryl and previcid to help with shrinkage.I love my little pooch more than anything, but I do not want to cause her further harm. Dr. Dresser, Do the benefits of this treatment out weigh what is the most pobable outcome in a dog this age? I feel very conflicted about how I should proceed with her.

    • Michael on April 18, 2013 at 1:32 pm

      Our 6-year old Portuguese Water Dog was diagnosed with nailbed digital melanoma 13 months ago, at which time they amputated his left front digit. Following the surgery, a chest x-ray and lab. work found no melanoma in his body. He, then, received a series of melanoma vaccinations with follow-up vaccinations to be given every six months. A chest x-ray, 5 months ago, showed no signs whatsoever of melanoma and his lymph nodes seemed to be fine. He went 13 months without any signs of melanoma and exhibiting very good health. However, yesterday, a new x-ray of his chest showed that lesions had formed and the diagnosis is grade 4 melanoma. He has been prescribed 60mg of Palladia to be given every other day (his weight is 52 lbs) to be followed by another chest x-ray in one month’s time. We do appreciate hearing your suggestions. Is their any hope for him at all? We love him so much. We don’t want him to suffer if it gets to that point. Any advice would be most appreciated.

      • Dr. Demian Dressler on April 24, 2013 at 12:47 pm

        Dear Michael,
        well, things have been going pretty well so this must be devastating.
        At this stage is seems prudent to start considering some of the other tools we have in addition to conventional care.
        I would start here:
        https://www.dogcancerblog.com/blog/an-overview-of-what-else-can-i-do/
        I think also the Guide would be a quite good investment and is an easy read as it addresses this question more fully and provides an action plan you can work out with your veterinarian’s input.
        I hope this at least gets you started in the right direction
        Dr D

      • Dr. Susan Ettinger on April 28, 2013 at 2:49 pm

        Michael,
        Sorry to hear about the melanoma metastasis to the lungs. I agree with the Palladia as a metronomic chemo. The goal of this chemo approach is anti-angiogenesis – to target blood vessels. There is more about this in the guide. I would also booster with the melanoma vaccine if it has not been administered weekly. I also use Apocaps on non-Palladia days, so discuss it with your oncologist. Good luck and good health to your dog!
        ALl my best, Dr Sue

  8. Susan Richardson on July 19, 2012 at 1:38 pm

    Dr. Dressler,

    My 10 year old Golden Retriever Harley was diagnosed with nasal adenocarcinoma (right side) in early March 2012. After radiation treatment, the oncologist recommended Palladia over the other IV chemo agents. Even though this drug is being studied in other cancers, such as nasal tumors, my dog Harley was excluded as the tumor had entered her cribiform plate. I was surprised initially how well she seemed to tolerate the Palladia. No common side effects have been seen since starting on Palladia the first week of April. However, in just 3 months with normal monthly labs, she became lethargic and her RBC count dropped to 150,000, with elevated AST and ALT levels 21/2 times above normal. Just took her back to the oncologist and they have determined that she has severe liver damage. Ultrasound does not show a mass, but the liver is abnormal. She also has a GI bleed. A biopsy cannot be performed unless they can stabalize her blood coagulation. Although they are only giving her a 10-15% chance of survivial, I’m am hoping a plasma tranfusion may help her in order to determine the cause of the toxicity to the liver through biospy. Being in the pharmaceutical industry and reviewing the clinical trials extensively on Palladia before opting to choose this treatment, I am in shock that she could have been doing so noticiably good on this drug, yet now showing significant liver damage. I have to believe the Palladia is the cause of the liver damage, but wanted to get your thoughts about Palladia and liver damage issues. I now believe that this drug is highly toxic and would have reservations utlizing as a choice for chemotherapy. Any insight would be greatly appreciated.

    • Dr. Demian Dressler on July 24, 2012 at 9:11 pm

      Dear Susan,
      There are cases of liver toxicity with Palladia I am sorry to say. The drug is not good or bad…but it feels horribly bad when side affects hurt your loved one. And there is no getting around it after the fact. Again I am sorry. Hopefully once things stablize they will start things like denosyl/milk thistle with SAM-e, LD or other liver diet, Actigall etc..if indicated…
      As to not showing signs, see this post:
      https://www.dogcancerblog.com/blog/signs-of-dog-cancer-and-decompensation/

      I’d be thinking of additional tools to treat cancer as discussed in the Guide.
      I hope this helps
      Dr D

      • Steve Morris on December 17, 2012 at 1:05 pm

        I first started van blastein cycle then afetr a few months mast cells reappered, the next cycle with Palladia as it was just released 15 months or so ago. I got a 12 lb Toy Manchester Terrier (1) cycle went ok we lowered dossage form 30 to 20 mg 3 times a week went for 6 months all signs of mastcell tumors vanished.
        after 90 days + a month or two started back on Palladia 2nd cycle Saprky did not tollerate teh same dossage as before , would wimper or cry in in his sleep, loose stool, even at 12 years old he used to jump (fly) into my water bed within a few months of his cycle he would fall trying to enter bed a few times after about 3 months Vet’s said to take a break for a week , When Sparky was well he would cure up to sleep with me, under my chin for about 15 minutes then go to his side of the bed , But when he wa sick or did not feel too good , he would sleet teh whole night under my chin and cry and wimper in his sleep. After a week off of a 3 month / 6 month cycle -sparky necer missed a jump on the bed, began running afer his ball, adn acting like a puppy and playfull again now a about three weeks
        off palladia his quality of life in 99% My god forgive me, but I decided to abort anymore Palladia adn keep the 2.5 mg Predisome daily 1/2 tab Beneydril cas 2X a day along with Flormodiean 1/4 30mg cap 2x a day Saprky is 12 in January 7th been on Chemo for 6 years , now twelve healthy and off Palladia . I fully understand in about three months or so the mass cell cancer may return again
        I can only hope his quality of life will continue for as long as possible , as long as nature permits his life to be free of pain and a quality of life he will remain with me. It’s Xmas perhaps our last togeather , I will treat each day as special with my boy. And I’m thank-full that I’ve had someone to love that loved me back unconditionally going on 12 years now …I hope I made the right decession and again what ever time I have left with Sparky I will try and make his last year or hopefully years the best I can as a human … I guess I never loved anyone as much as my Sparky . Sparky’s Dad Steve

      • Danielle Sheppley on April 14, 2013 at 5:15 pm

        My 11.6 yr old Cairn Terrier was diagnosed on Jan 15th of this year with hemangiosarcoma. He has had no surgery. We were told he wasn’t a candidate. He has had 3 doses of Doxorubicin. These treatments were discontinued this week as he has had continued fluid accumulation in his chest. He was started on Palladia two days ago. I had your book delivered 2 days ago and have ordered the Apocaps, K-9 Immunity and K-9 Transfer Factor. He takes 20 mg of Prednisone 2x’s a day to try to help with the fluid accumulation. His oncologist suggested implanting a port for more easily removing fluid from his chest. Are we following the right path? We are implementing your suggestions as quickly as we can. Our beloved boy has not given up in any way so we continue to try anything we can to help him.

        • Dr. Demian Dressler on April 24, 2013 at 10:28 am

          Hi Danielle
          This sounds very difficult, I am sorry.
          Other steps for you to consider, all under veterinary supervision:
          dog cancer diet
          milk thistle or denamarin (extra, on top of what’s in Apocaps) to assist with pred side effects
          yunnan baiyao (in Guide also)
          diuretics (furosemide, spironolactone), rutin, dandelion for fluid in chest
          If palladia does not work could try low (half) dose oral neoplasene combined with mirtazapine (in Guide)
          I hope this helps
          Dr D

    • Amy on December 18, 2012 at 10:28 am

      Hi….I have a 7 yr old black lab, female. She has had surgery twice now, for mct….one lump on her mouth, and another on her shoulder. Both tested positive for the mast cell carcinoma……. She now has another mass, and we have been referred to an oncologist. Palladia has been mentioned for her, but we were told it is VERY expensive. Anyone have any price range for me? She is going to the oncologist tomorrow, and she has a very weak stomach as it is. She is very healthy and active, but her stomach gets upset very easily. Just wondering if it is worth trying, or if there is something better available??

  9. Winter on July 8, 2012 at 4:06 am

    My dog, Penny Lane, is an 11 yr old English Shepard mix. She was diagnosed with insulinoma two years ago. She had surgery to remove a tumor on her pancreas and there was some cancer cells on her liver at that time. Since surgery she has been on prednilisone 5 mg per day and has been doing well. Recently her blood glucose has dropped to 55-60 and her pred dosage up’d to 10 mg per day.
    Has there been any use for Palladia with insulinoma cancer? Is there a drug interaction with steroid use?
    Thanks!

  10. JV on July 4, 2012 at 3:06 pm

    I have a 13 year old Parsons Jack Russell Terrier who was just diagnosed with a MCT in his groin area. A month ago he had a growth removed from his scrotum. Originally Our veterinarian thought that he had some kind of infection from a insect bite or a thorn. During the process with what he thought was an infection we were put on three different antibiotics. Two weeks into the antibiotics his prepuce swelled up and had pus filled blisters all over his groin area. The swelling eventually reduced and these blisters popped and a large amount of puss came out. He then removed his scrotum. Two weeks after the surgery a small area of swelling still present that had originally been filled with blisters and puss. That area has now turned into a tumor the size of a racquetball. We see the oncologist on Saturday.

    Today he had a shot of steroids and a shot of Benadryl and we will be keeping him on a daily dose of both. I understand the situation I’m faced with does anyone else out there have a Jack Russell and went through similar situation that could give me their advice or experiences.

    I would appreciate anything anyone would be willing to share with me. Thank you to everybody who posts on these websites I’ve gained a lot of information.

    • Michae G on October 2, 2012 at 12:44 pm

      Dr. D

      I have a 9 1/2 yo English Bulldog and as everyone here, he means the world to me. He was diagnosed with a MCT recently. We immediately had it removed with with generous margins 1″ margins on each side. The margins came back clear and the tumor was determined to be the lowest grade 2 it can be (almost a 1). This has been the only tumor thus far. My vet has been very good and has reached out for opinions from oncologists he knows and what has been mentioned is 1. wait and see, 2. chemo which Paladia has been mentioned but heard good and bad, 3. go in and take another 2 – 2 1/2 cm margins in a couple of weeks are the main course of action I am hearing.

      Generally I feel we got are fortunate to have as low a grade MCT as he did but it has also caused a little bit of a dilemma when trying to decide how to go forward. I feel like doing nothing is being reactive but may very well be the best choice, chemo may be over doing it and I hear so many bad things about some drugs and the side-effects. At this moment I am leaning towards having my vet take more margins. I feel like we may be taking a shot into the dark and that goes against my nature. With what little I have given you (but is all we know) can you give me your thoughts?

      Thanks so much and prayers go out to everyone and their pups.

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