GREAT NEWS! Merck’s Keytruda Immunotherapy Drug SHRINKING CC TUMORS!
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Dear Colleen,
Please give your dear mother a hug for me! I am so happy for you and your family! This is a HUGE success! You know my feeling on immunotherapy…..now if we can just get the brilliant minds of the world to get it to work for everyone….all would be great!
Also please thank your mother for her participation in this trial and bringing so much future hope to others!!
All my best, hugs and prayers,
Melinda B.Great article on http://www.sfgate.com regarding immunotherapy.
Sponsored by: UCSF Medical Center
Titled: Killing cancer through the immune system
http://www.sfgate.com/sponsoredarticles/adv/?prx_t=yZsBA69MBApB8LAHi CC community,
Wanted to provide an update on my Mom as of 10/14/14. She’s still doing VERY well and continues to be an inspiration to all of us. Thank you again for all your kind notes and well wishes. Together we will beat this!
#findacure #hope #believe #miraclesNote from Mom:
I am very happy to report we are seeing continued improvement with my clinical study drug, Pembrolizamab. In fact, the FDA recently approved this drug for the treatment of melanoma under the market name “Keytruda”. World-wide clinical studies will resume on various tumor types to determine whether this immunotherapy drug can be effective in treating other kinds of cancer.
My participation in this clinical trial began in June, 2014 after an ineffective three months regime on Gemzar and Cisplatin. I will have my 10th cycle treatment this Thursday. A PET/CT scan was done last week with very promising results. Several larger tumors have disappeared completely and all the other spots are continuing to shrink. The best news is there is still no evidence of any new tumors. The doctors are thrilled, and our hope is that this drug will continue to eradicate all the tumors in my body. Our goal is to be cancer-free. Speaking from personal experience, it is an incredible drug with little or no side effects. I feel fine. It would be an amazing breakthrough if all cancers could be treated with immunotherapy instead of with toxic chemotherapy/radiation which causes so many harmful side effects.
I look forward to my QiGong and Tai Chi classes. These meditative movements are designed to increase flexibility/ balance and to help find inner peace/calm. It’s actually harder than it looks. I can’t do any of the movements without following the instructor step by step. Actually, I’m kind of lousy at it. The important thing is I enjoy it and truly believe it is beneficial in my fight with cancer.
So, the news is still hopeful for a good outcome. I will be forever thanking you for all your prayers and good wishes.
Thanks!
Love,
RoseThanks for this info! I will definitely bring this to my onc’s attention next time I’m there.
As far as insurance coverage… I think it depends on the ins co. But I had a nurse navigator thru AETNA that fought the red tape for some “non approved” care. I.e., PET scan, and my care at Fox Chase. AETNA wanted me to get med care at my capitated, local hospital, and it took her about 3 days to get through to them, but finally I was allowed to go to Fox Chase for everything.
Check with your insurance about such a person, if you don’t have one. They are much better at navigating the system than we are.cholangio……I understand what you are saying and therefore recommend the option of gaining access to this drug by enrolling in a clinical trial. Chances of off-label use increase if a Phase II data is released, but at present we are far removed from that.
Investigational use is another (remote) possibility. Here is the information:
http://www.fda.gov/newsevents/testimony/ucm115209.htmRegarding insurance coverage: I hope for someone to come forward and share experiences with us.
Personally, I recall the year 2008 and Avastin ( Bevacizumab.) This angiogenesis inhibitor had not been tested on CCA patients and yet some were approved by their insurance companies whereas others were denied by their individual carriers. In the approved cases a physician contacted the pharmaceutical company directly and then followed up with the insurance carrier.Hugs,
MarionCholangotango,
My understanding is that drug companies race to get FDA approval, ANY FDA approval, because that opens up the “off-label” market. I believe the “off-label” market is very lucrative.
My guess is that Merck will have lots of Keytruda available pretty quickly for off-label use, because this is exactly why they were racing to be first out with an anti-PD1 drug (and they only have the advantage until some other company, like BMS, gets their PD1 drug approved).
What I don’t know is how you can get an insurance company to cover the costs of using a drug off-label. Do insurance companies do this??
Hopefully someone with more experience with insurance companies can chime in here.
Jason
cholangio…..agree, the drug cannot be prescribed unless it receives FDA approval To obtain that, pharmaceutical companies must conduct clinical research studies (Phase I, II, and Phase III.) Once successful the drug can be prescribed “off label” for any disease.
At present, the only way for your Dad to “potentially” benefit from the discussed drug, he must enroll in a clinical trial.
Hugs,
MarionThis is all great… but it’s not approved for CC, and from what at least one Onc I’ve spoken with tells me, getting it approved by Merck for off label prescription is near impossible. If anyone has any ideas how to get it (assuming insurance agrees to pay) please let us all know.
For those interested, below is an excellent group of panel discussions on immunotherapy:
http://www.onclive.com/peer-exchange/immunotherapy/Targeted-Immunotherapy-in-Cancer
Had to look it up. Studies for advanced tumor are recruiting in numerous centers. Please know though that this is a Phase I study – Researchers test a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
https://clinicaltrials.gov/ct2/show/study/NCT02054806?term=pembrolizumab&rank=12&show_locs=Y#locn
Hugs,
MarionColleen,
I am so happy for you and your mother!! Thanks again for sharing and bringing hope to others!! Please keep us posted on her progress. When will she be evaluated again? I absolutely agree with you …..this is the future for fighting cancer and with such great quality of life! Thanks for sharing and give your mom a hug!
MelindaThis is great news Colleen! I actually sent emails to a foundation out there to see if I could get my dad into the UCSF trial, but it was full. I’ve been following the checkpoint inhibitor drugs every since my dad was diagnosed in May. Fortunately, my dad is so far responding to the chemo, but it is fairly rough on his immune system. After the 1st cycle he came down with pneumonia, and they also found blood clots. Thats been handled, but it was a little scary. He’s been off chemo for 1 month, and is back to “normal”, but he starts back up this Friday. I really don’t like what the chemo does, but there aren’t many options at this point. He’s at MD Anderson, and they’ll evaluate him for proton beam therapy on our next evaluation. I’ll of course talk with his doctor again about the anti PD-1 drugs (I don’t know when BMS’ drug will be approved).
Anyway, this is a good data point, and I hope we start getting published results in the next 3 to 4 months. Please keep us informed of your mom’s progress, and know we’re all pulling for you and your mom!
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