FDA Places Clinical Holds on Opdivo and Keytruda for Refractory Multiple Myeloma

The recent news are related to combinations of Opdivo (nivolumab) and Keytruda (pembrolilzumab) tested in clinical trials for patients with refractory multiple myeloma. Here is discussed the specific trials that have been halted for:

  • Opdivo (Ref.)
  • Keytruda (Ref.)

These drugs are some of the stars-drugs developed by some of the major pharmaceutical companies as part of the immunotheraphy wave of drugs to treat cancer. I already discussed shortly some of these drugs, here (Ref.).

The clinical trials have been halted due to large number of deaths that have occurred during the clinical trials.

This is important information given that private clinics around the world are using the anti PD1 drugs Opdivo and Keytruda as off-label drugs, possibly also in multiple myeloma patients.

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3 thoughts on “FDA Places Clinical Holds on Opdivo and Keytruda for Refractory Multiple Myeloma

    1. Thanks Pouya.
      Interestingly, your link refers to CAR-T treatment. I was not aware about these news:
      http://www.genengnews.com/gen-news-highlights/after-patient-death-fda-places-clinical-hold-on-cellectis-car-t-candidate-ucart123/81254886

      Recently, Novartis was approved a new cancer treatment, CAR-T, strongly marketed as a breakthrough cancer treatment.
      Now, just a week after the FDA approved Novartis’s CAR-T drug, another company called Cellectis who is also developing its own CAR-T drug, saw their first treated patient death soon after applying the treatment.
      The clinical trial was put on hold but I guess must probably they will be allowed to continue in some months from now.
      Another company having its own CAR-T drug is Kite Pharma, very recently acquired by Gilead Sciences.

      Seeing such a reaction it is not surprising form me knowing this is a drug seriously interfering with the immune system. It is clear for me that while the immuno therapy is a promising space where anti cancer solutions may be found, the world is in a very first phase of how the immune systems actually works. This is why, from my point of view, strongly interfering with the immune system means accepting potentially lethal side effects as long as we do not understand it, which is the case today for humanity.
      This is also why, I think such immuno therapy new drugs should be used only when the risk of death without treatment is large and there are no other treatments available.

      As previously discussed, another way to reduce the chance for lethal side effects when using immuno therapy is to reduce the dose. It seems that in case of anti PD1 treatments, monthly dose as low as 1/6 of normal dose may still be effective while its cost and potential side effects are strongly reduced.

      1. Thank you Daniel.
        So while my mother is in the hospital i managed to get a bit more time in front of the computer and saw this video https://www.youtube.com/watch?v=gWuJdUJsLuo
        Then i got here to ask about it and behold, my email also rang with the article 🙂 you’re very fast and after reading i can only agree.

        Thank you for everything you’ve done and are still doing and will be doing for everyone here including my mother.
        Alex

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