MRF-Logo2019-Horizontal-RGB
GSK2141795 working but not manufactured by Novartis anymore
REGISTER
The information on this site is not intended or implied to be a substitute for professional medical advice, diagnosis or treatment. Content within the patient forum is user-generated and has not been reviewed by medical professionals. Other sections of the Melanoma Research Foundation website include information that has been reviewed by medical professionals as appropriate. All medical decisions should be made in consultation with your doctor or other qualified medical professional.

GSK2141795 working but not manufactured by Novartis anymore

› Forums › General Melanoma Community › GSK2141795 working but not manufactured by Novartis anymore

  • Post
    • March 26, 2017 at 2:40 am
    Raegen
    Participant

      I am a Phase I clinical trial participant with a BRAF V600K mutation at the University of Michigan involving a combination trial between Dabrafineb, Trametineb, and GSK2141795.  I am one of four out of eleven patients whose metastatic melanoma has stabilized at U of M during this trial.  GSK2141795 is owned by Novartis, but was manufactured by GlaxoSmithKline.  

      Novartis refuses to manufacture any more GSK2141795 and we run out of meds on April 30.  

      Does anyone have any extra GSK2141795?  Or know any details regarding the sale of GSK's oncological division to Novartis in 2014?

      Novartis included the information regarding GSK2141795's unavailability in the trial paperwork we all signed, but it came along with a verbal promise that another drug was under development and would be ready to take its place.  It's not ready and they don't want to manufacture any more of it.

      This is such an emotional rollercoaster; I run from being grateful for having a few extra months to live, to feeling really angry that a drug company knows how to solve this issue, but refuses to do it.  I was hospitalized for 6 days with allergic reactions and risked blindness three times with dosage adjustments to prove out this drug.  Now it's working and there isn't any more of it.

    Viewing 1 reply thread
    • Replies
        • March 26, 2017 at 5:56 am
        jennunicorn
        Participant

          Unfortunately this can be a risk of joining an early stage trial. So sorry you are having to deal with this right now. Have you tried Dabrafineb/Trametineb alone? If not, then you could try those alone as they are already approved combo. I can't imagine the frustration you're going through right now. 

            • March 26, 2017 at 10:50 am
            ed williams
            Participant

              Dear Anon #2, the first Anon has a Braf mutation v600k which is different to the common Braf v600E, as I under stand things the approved Braf targeted drugs don't work for this very small subset of Braf patients. However Mek inhibitors do show response!!!! Best wishes!!! Ed

              • March 27, 2017 at 12:42 am
              Raegen
              Participant

                Mmmhm…Actually, I had a great response to the Mekinist/Tafinlar combination as well – the two tumors on my jaw next to my ear just melted away.  I couldn't tolerate those drugs for very long, however.  The fever/chill cycle was horrific.  My immune system tends to over-rev on many of these drugs due to, I believe, a sensitivity to dairy.  I feel like I am dragging the immunology profession along behind me.  It is a thought…I might be able to return to that combination as well.  Just not one drop of milk and no butter anywhere in my life…

              • March 26, 2017 at 1:23 pm
              Bubbles
              Participant

                Sorry that you are dealing with this.  Big Pharma is all about money.  Perhaps they did not see the drug you found helpful as something that could be marketed to enough folks to be lucrative…who knows? However, I would talk to my doc about finding other AKT inhibitors that you could use if the study drug was helping you.  ARQ 092 and ARQ 751 by ArQule might be an option.  Miltefosine is actually FDA approved albeit for leishmaniosis.  Another option for you may be PI3K inhibitors.  PI3K is the step in the pathway just before AKT.  Bparlisib and Alpelisib are in trials for breast cancer (and recently in mice for melanoma).  Duvelisib for hematologic malignancies.  TGR 1202 for follicular lymphoma.  Perhaps you could gain access to one of these or a similar product.  Here is a post I put together just this weekend with a cool diagram of the pathways and information you may find helpful:  

                http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2017/03/what-tangled-paths-we-weave-nilotinib.html  

                Additionionally, Ed is right.  Some folks in your position are doing well with MEKi administered as a single agent.  Another possibility may be participation in this NCI match trial:

                https://clinicaltrials.gov/ct2/show/NCT02465060?term=nci+match&rank=1

                Hope you find a workable treatment soon.  I wish you well.  Celeste

                  • March 27, 2017 at 12:33 am
                  Raegen
                  Participant

                    Thank you so much, Celeste, for your thoughtful reply.  They just told me there wouldn't be any more GSK and turned me loose.  I didn't know there were any alternatives…

                    Thank you, thank you, thank you!!!  Raegen

              Viewing 1 reply thread
              • You must be logged in to reply to this topic.
              About the MRF Patient Forum

              The MRF Patient Forum is the oldest and largest online community of people affected by melanoma. It is designed to provide peer support and information to caregivers, patients, family and friends. There is no better place to discuss different parts of your journey with this cancer and find the friends and support resources to make that journey more bearable.

              The information on the forum is open and accessible to everyone. To add a new topic or to post a reply, you must be a registered user. Please note that you will be able to post both topics and replies anonymously even though you are logged in. All posts must abide by MRF posting policies.

              Popular Topics