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Home » My Health Updates » Tell the FDA that we need Tivo!

Tell the FDA that we need Tivo!

Posted by on May 23, 2013 in My Health Updates - 24 Comments

As you might recall, a few weeks back, Chris and I both were soundly dismissed by the FDA’s Oncological Drug Advisory Committee (ODAC), at a hearing regarding the approval of Tivozanib — a new drug for kidney cancer.

Sure, we’ve struggled with the rejection. Called them repeatedly in the middle of night. Cried. Stood outside the FDA with a boombox playing “In Your Eyes.” Drank a little too much vodka, cried some more, called them again. But, time heals all wounds, right?

WRONG. We’re still mad.

Since our singular efforts haven’t been successful, we’re hoping we can enlist YOU to join our efforts. Below, you’ll find a sample letter to send to Dr. Richard Pazdur, who is the Director of the Office of Oncology Drug Products at the FDA. We may not change their minds, but we can make our voices heard!

Dr. Richard Pazdur

Director of the Office of Oncology Products

10903 New Hampshire, Suite 2212

Silver Spring, MD 20993

 

Dear Dr. Pazdur,

As a (kidney cancer patient, caregiver, family member, etc…), I’m writing to you today to express concern about the recent ODAC decision regarding the cancer drug Tivozanib.

Seven years ago, there was only one FDA approved treatment for renal cell carcinoma. Today, there are seven additional drugs available, in no small measure by efforts of you and your staff at the FDA. These targeted therapies, a new class of drug, have allowed many RCC patients to live for years even after receiving dire diagnoses. Each new generation has been more selective and more potent – lowering off-target side effects and allowing them to be combined with new agents to be even more effective.

Using these drugs sequentially has proven even more advantageous for patients than using any one particular drug alone. While one drug might stop working after a period of time, we now have the ability to turn to additional drugs with improving progression free survival rates to prolong disease control.

While we agree that the drug’s sponsor could have designed a better trial, Tivozanib showed a superior progression free survival advantage that surpasses all of the current drugs available. For kidney cancer patients, progression free survival is the only endpoint for a trial that matters since the drugs are used in sequence.

Many of the comments expressed at the committee hearing were disheartening to kidney cancer patients. It was especially concerning that not one member of the panel was a renal cell specialist — considering the number of such specialists who felt that this drug would benefit their patients.

Dr. Pazdur, RCC patients need this drug. Many patients have already run the course of all of the drugs available and are running out of options. Years of data and trials have shown that this drug is not only effective for renal cell but also that – with its enhanced side effect profile and longer progression free survival rate – is superior then currently approved treatments.

We encourage the FDA to work closely with Tivozanib’s sponsor to ensure timely market access to this drug.

Sincerely,

 

  • Nick Puleo

    My oncologist sees this as a setback for Tivo, but speculates Aveo will design a new trial with different endpoints, since they have enough investment in the drug to justify going forward. I think when these companies fail to meet their own endpoints, the committee members don’t have much choice.

    • Dena Battle

      Nick, I do agree that Aveo should have designed a better trial. But, the primary endpoint was progression free survival, not overall survival. Aveo met the primary endpoint by showing a superior PFS (substantially superior). I hope that Aveo will design a new trial — if they don’t go into bankruptcy. But, a new trial likely means five more years before patients have access to the drug. I think the committee did have a choice. Patients are paying the price.

  • Maryalice Haest

    Consider it done!
    Praying that Chris is feeling better and that the side effects have diminished.
    You are all on my mind and on my heart.
    Maryalice

  • Phillip

    Sorry if this is a little to cute, but I am not creative enough to write my own. And this song sums up your call to arms perfectly.

    I am RCC warrior, hear me roar
    In numbers too big to ignore
    And I know too much to go back an’ pretend
    ‘Cause I’ve heard it all before
    And I’ve been down there on the floor
    No one’s ever gonna keep me down again

    Oh yes, I am wise
    But it’s wisdom born of pain
    Yes, I’ve paid the price
    But look how much I gained
    If I have to
    I can do anything
    I am strong (strong)
    I am invincible (invincible)
    I am RCC Warrior

    You can bend but never break me
    ‘Cause it only serves to make me
    More determined to achieve my final goal
    And I come back even stronger
    Not a novice any longer
    ‘Cause you’ve deepened the conviction in my soul

  • Allen

    RCC Patient here. Mine is going in the mail today.

  • Kevin

    Battle Family – I wish to cc you on my letter to Dr. Padzur. I am with you and your fight. Please e-mail me at P_Rogers@att.net

  • Mary

    Consider it done – with a copy to my Congressional Representatives.

  • Steve Krause

    Here’s the letter I just sent to Pazdur (note spelling and address), and to the members of the Missouri delegation to Congress:

    Richard Pazdur, M.D.
    Food and Drug Administration
    Center for Drug Evaluation and Research
    Office of Oncology Drug Products
    5901-B Ammendale Road
    Beltsville, MD
    20705-1266

    Dear Dr. Pazdur,

    As a friend of long-time renal cancer patient Chris Battle, I’m writing to you today
    to express profound concern about the recent ODAC decision regarding the new
    cancer drug Tivozanib.

    Chris and his wife Dena attended and provided testimony at the hearing during which the advisory committee rejected “Tivo.” The report afterward was very disturbing. It is not the committee’s decision that bothers me because I am not qualified to evaluate it. What bothers me is that, apparently, neither was the committee.

    It was clear to Chris and Dena that most members of the advisory committee had made up their minds before ever entering the room that day. Their questions were skeptical and even hostile. And not a single member of the panel was a kidney cancer specialist. The 13-1 vote pretty much speaks for itself. Only the patient representative voted “YES.”

    Well count me with the patient representative. I care whether Chris gets the best medicine the world can offer because he’s my friend, and because like millions of Americans the scourge of cancer has attacked my family, too.

    Dr. Pazdur, I don’t know whether Tivo is a good drug or not. I’m a retired aerospace marketing executive, not a physician. But I do recognize lackadaisical, perfunctory, biased, bureaucratic government behavior when I see it. That’s what it looks like Chris and his fellow kidney cancer fighters got from this group. I hope that you can see it, too, and that you will do something to fix this.

    Sincerely,

    Steven L Krause
    St. Louis, MO

    Senator Roy Blunt, 260 Russell Senate Office Building, Washington DC 20510
    Senator Claire McCaskill, 506 Hart Senate Office Building, Washington DC 20510
    Representative Ann Wagner, 435 Cannon House Office Building, Washington DC 20515

  • Chris Fegles

    Dena & Chris, Mike & I will each send a letter today!!! Do you think it could help if we all repeatedly send a letter once a week for a period of time? Most of us that follow your family have never met you, but we love you. ;-)

  • Chris Fegles

    Dena or Steve, Should we send a letter to each address? And i’m guessing the spelling to be “Pazdur”.

    • Dena Battle

      You guessed correctly – it’s Pazdur. I just updated the letter to correct my mistake ;) . That’s what happens when I post before my eighth cup of coffee! (or is it after my eighth cup of coffee…)

  • Dena Battle

    The Silver Spring address is Pazdur’s office. However, if you send letters to the Oncological Drug Products office in Beltsville, I’m sure it will get to him as well. Thanks everyone!

  • Erin Oliver

    I’m in! And I’m going to ask (read: forcibly make) all my friends to do the same.

  • Colleen Hosken

    Will send the letter. I’m a friend of Sue Plummer’s in the Villages. Have followed your journey for a few months. This situation is just not right.

  • Jonathan Parker

    You were not dismissed at the ODAC, you were not considered because there is a thought process issue and the FDA had already made a recomendation for a new trial. The debate about Tivozanib is not about drug effectiveness or even risk reward, its about prospective analysis versus retrospective analysis and FDA power- they favor prospective trials. Its even clearer the decision was already made when you see the FDA place on their chart for ODAC that an HR of OS of less than one favors the investigational drug- because while this is true for all the other trials and is the way most prospective trials are set up the Tivozanib trial was set up with an equivalent active drug, and with the one way cross over then unintentionally set up the opposite way-this is not the case for placebo cross over. The only way the HR could be less than one is if the 61% who switched from sorafenib to tivozanib were negatively affected (killed them) by that switch. If switching from sorafenib to tivozanib were beneficial (it matches the sequential use you mention) than a single treatment of tivozanib, the comparator arm got the more effective treatment, and HR should be better than 1. It is not statistically different than 1, but the confidence range is .95 to 1.62, suggesting a there is a likely benefit to switching versus staying on sorafenib after a period of time compared to a single treatment. The FDA is basically saying they wanted the trial to be double cross over to distribute the benefit of changing over to be distributed in both arms to reduce the effect of this benefit on the trial results and HR equivalent to 1. So when people are arguing about the OS data in the trial being poor, its because they have been conditioned to think an HR greater than 1 is bad, when in this case all it means is tivozanib was an effective 2nd line drug, not that it was less effective than sorafenib.
    I too have written to Dr, Pazdur, with my arguement, but more voices are better. Your letter is very good but its my opinon you may want to add that the trial’s comparator arm OS results had sequential use of two active drugs which led to better treatment in the comparator arm and an HR greater than 1 and that sequential use of tivozanib after an active drug was shown to be superior to any other trials OS results. The HR results do not indicate inferiority as the ODAC board discussed, but showed the advantage of sequential use of two drugs compared to a single use of a superior drug. Good Luck, I have less skin in this game- only a AVEO stockholder, but also a medical device engineer who would like to see the patient put above other less important considerations,

    • Dena Battle

      Jonathan — thanks for such a thoughtful response. We completely agree with you. We tried to keep the letter from being too technical, so that folks from broader communities would feel comfortable sending it. The letter that Chris and I sent personally was somewhat more detailed. We’ve also reached out to RCC specialists and asked them to chime in. Unclear whether any of this will be successful – but like you, we hope that FDA will put patient needs first!

      • Jonathan Parker

        I see your point about not getting too technical from a patients perspective. Looking back at my life, I seem to like fighting against poor odds regardless of the outcome so long as its the right thing to do- failure really isn’t failure if you gave it your best- giving up is failing. Best of luck with your efforts in this matter, and more importantly with Chris’ fight against cancer. I will keep reading your blog.

  • Jonathan Parker

    By the way, I found a article Dr. Pazdur wrote in 2007 with this email address which i used. pazdurr@cder.fda.gov

  • SpeedyG

    Hi Dena,
    Do you have an email address? I would like to share an article with you and discuss how we can try to get FDA to change their mind. Thanks.

  • SpeedyG

    Dena,
    You can email me at hk32111@yahoo.ca TIA.

  • Bill W

    Chris,

    Seeking Alpha has a great article on the travesty of the FDA’s decision.
    http://seekingalpha.com/article/1472661-the-fda-vs-aveo-s-tivozanib-who-does-the-dying?source=kizur

    Also Exelisis has just announced that it has initiated METEOR, a phase 3 pivotal trial comparing cabozantinib to
    everolimus in patients with metastatic renal cell carcinoma who have experienced
    disease progression following treatment with at least one prior VEGFR tyrosine
    kinase inhibitor. The primary endpoint for the trial is progression-free
    survival.

    • Jerry

      So, one can have free access to cabozantinib or everolimus without bugging insurance company or unwilling physicians, with better and more professional care from elite cancer centers.

      • Jerry

        The dose for this trial is 60mg, seems Chris won’t have to stick with 140mg MTC pill. That may decrease side effects a lot.

  • Chris Rees

    Dena, please contact Chris Rees at tenstocks at yahoo dot com ASAP

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