• MLT's Avatar

    TNBC

    Asked by MLT on Friday, May 24, 2019

    TNBC

    Just heard from my oncologist that the new targeted therapy for metastatic TNBC, that was turned down by the FDA in Jan, will not even be a possibility until 2020 now. The drug company is not pushing for approval. Is this a game between FDA and drug companies? I am really bummed out about this!

    13 Answers from the Community

    13 answers
    • carm's Avatar
      carm

      No, obviously the drug must have failed at trial or the pharmaceutical house would push for release. If it will be approved in 2020, then I'm betting they will amend the indication. Please keep in mind that the FDA board members are not all medical professionals. Most are lay person's. It's designed to keep it fair. Having worked studies for years, if they don't pursue then the drug either failed or there is a side effect that demonstrated more risk than benefit.

      4 months ago
    • MLT's Avatar
      MLT

      Trial results were good. FDA didnt like the packaging. Been waiting on this for 6 mths. I know my onc has other choices, but this was #1.
      Thanks for giving me a little more understanding. Sounds like education. Not educators making the most important decisions for our kids.

      4 months ago
    • carm's Avatar
      carm

      I used to be a research coordinator for clinical trials. If the issue is the packaging, then FDA will hold if somewhere in the packaging they are claiming something unproven or something not backed by trial data. If the drug company is holding it up for packaging it is because they are amending the indication.

      4 months ago
    • MLT's Avatar
      MLT

      Thanks, Carm. The drug company is not doing anything at this point.

      4 months ago
    • carm's Avatar
      carm

      You are most welcome. I don't know what stage you are, but if you are a stage IV, then you can get that drug before approval from the FDA. Compassionate use, or expanded access is a potential pathway for any patient with an immediately life-threatening condition or serious disease /condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. Just be sure that you know the reason why it is not getting approval at this point. You can search that data on the FDA website by searching the drug. Best of luck to you.

      4 months ago
    • BarbarainBham's Avatar
      BarbarainBham

      Carm, that information is like GOLD for all of us to know and keep in mind as needed for us or someone else!! Would you mind copying it to Greg to post it to publicize to WhatNexters however he thinks is best, even if it's to our Questions that everyone sees?

      I'm Stage IV, and many others here are also. Ironmikey will be making a decision about his Gleevec soon. I will also be making a decision with my doctor Tuesday whether to stay on Gleevec for GIST.

      4 months ago
    • BarbarainBham's Avatar
      BarbarainBham

      I have a new doctor, and her resident told me that immunotherapy has not been approved for treatment of GIST yet. I can't remember if he said it was being researched, but I think he did. If so, it sounds like we might have hope of getting it if needed.

      Thanks, Carm!

      4 months ago
    • lujos' Avatar
      lujos

      @BarbarainBham, hadn’t heard of that drug, but after a quick search, it sounds amazing! Does it work as well on GIST as it apparently does on CML? How are the side effects?

      4 months ago
    • BarbarainBham's Avatar
      BarbarainBham

      Lujos, if you're talking about Gleevec, it's the most effective of the three drugs for GIST. I believe I was told Gleevec is 80% effective on GIST. I've been experiencing nausea and trouble keeping it down the last couple of years, so mentally have gotten where I hate taking it. I've been on it since 2013, and the first few years were good.

      Do you know someone with GIST or CML?

      4 months ago
    • lujos' Avatar
      lujos

      @BarbarainBham, a friend has CML, being treated in the UK, but it does look like it’s available here. I notice that it’s in tablet form — I just finished tablet chemo myself, found it a much lonelier experience than when I had IV chemo...

      4 months ago
    • MLT's Avatar
      MLT

      Carm, I am metastatic. Have been on low dose Adriamycin for a year with good results. Don't know how much longer I can continue. Thanks for the extra info. See my oncologist on Thurs.

      4 months ago
    • carm's Avatar
      carm

      To all those above...FYI, just so you know that if you get any drug for compassionate use, your insurance will probably not cover it. However, if your MD fills out a form and attaches the insurance denial letter, you will get the drug for free from the pharmaceutical house.

      4 months ago
    • MLT's Avatar
      MLT

      Thanks, Carm! You are a wealth of info!!

      4 months ago

    Help the community by answering this question:

    Create an account to post your answer Already have an account? Sign in!

    By using WhatNext, you agree to our User Agreement, and Privacy Policy


    Read and answer more mixed tumors, breast cancer questions.  Also, don't forget to check out our Mixed Tumors, Breast Cancer page.