Ibrance (Palbociclib)
Comments
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Joyner, Thanks for posting that discussion of Abemaciclib! Constantine has it just right! And now there is a trial combining Abemciclib with Keytruda, and I so hope the combination is synergistic (ie, the benefit is much better than additive)- wouldn't that be awesome?!
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Cutting out now- Merry Christmas, everybody!!!!
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Grannax2: my main one was my T-4 that is where they found the tumor. Plus I have a compressed fracture from the T-4 because it lost height. I have one in my T-3, T-4, T-5,T-7, L-1,L-4, & S-1. They put in titanium rods and screws in August (the day before my 38th birthday) from T-2 to T-8. He was concerned about 7 because it was looking like it could become a compressed fracture. I also have a small cage between 3-5. They had to rebuild my 4th because the tumor ate away most of it.
Yeah I was almost a four year survivor when this hit. It has been hard but luckily I have my father and my fiancé who can open things for me lol. Rads were hard on me too but they helped so much getting me mouthwash and a list of foods but I did eat a lot of baby food and ice cream. They told me I was lucky it hasn’t hit my organs or didn’t which I thought it would. I get the lovely bone scans every month.
Yes I am glad my bones are healing and hope the ibrance shows it’s doing a great job at the next bone scan in February.
Wow I really thought it was in my neck but it wasn’t. Even my surgeon said he was surprised too. But it being all in my back is the downside. I am about to medically retire because I work in retail been on medical leave since late July when this all happened. Yeah I have to always explain what goes on with me and I write about it too. Thanks so much for the encouragement and it makes me hopeful to live with metastatic longer than they are giving me.
Have a merry Christmas!
Chani
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Yeah, Cure-ious - I saw that there was a trial for Abemciclib with Keytruda in the famous research hospital, and am crossing my fingers to be part of that !
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hi friends thanks for your words
Also for all the valuable information you provide.
I wanted to wish you all a wonderful xmast . I know for some this time of the year is very important and I send you big hugs.
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happy holidays everyone. Merry Christmas wishing everyone a happy and healthy 2018
Jo
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I wish all of you a Merry Christmas and pray that next year brings you joy and peace. Thank you for all the kind words and hope you've offered this past year, my friends. God is still in the healing business as we see here everyday. Love to all of you from PatG
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For my fellow Canadians, ribociclib (kisqali) will be reviewed by the pan Canadian Oncology Drug Review in March 2018. There is a one to two month process following the review meeting. Assuming that pCODR recommends that the provincial health plan fund the drug, it will then be forwarded to the panCanadian Pharmaceutical Alliance to begin negotiations with the manufacturer. As far as I can tell, there is no application in progress yet for any other CDK46 inhibitors.
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Thanks for the update Hobbes. So March 2017, FDA approves Kisqali, and March 2018 its still in some process of being approved in Canada. Good grief, that's a long time lag between US and Canadian approval. Abemaciclib was FDA approved in late September of 2017. So likely we are looking at a similar time frame for it.
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Husband11, I read Hobbes post to mean that they are reviewing Kisqali for funding under Canadian health plans, not seeking approval for use in Canada. I don't think that Ibrance has gone through this funding review yet but it is available for use where private plans will cover it. But perhaps I'm wrong.
Like you, I am hoping that Abemaciclib gets the nod here soon. Ibrance was a bit too hard on my blood (although my onc is thinking we might try it again at a lower dose - would have to be 75 mg as I was already at 100 mg). I would like the option of combining it with a second line of hormone treatment (Anastrozole failed).
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Canada represents 2% of the global drug market, so manufacturers are slow to start the approval process in Canada. There is nothing that Health Canada or the provincial agencies can do until the manufacturer requests a review. A 2 year difference between the FDA approving a drug, and the manufacturer starting the process in Canada is not unusual. The manufacturers go after the big markets first: the US, Japan, England and the EU. Canada represent small change!
Ibrance was recommended for funding over a year ago and has been in negotiations between the provinces and Pfizer since then, but there is blackout on the process so none knows where those negotiations are at. Pfizer charges US Medicare and Medicaid $10,000 US /28 cycle, regardless of the dosage, and has just agreed to $3,000 US/28 days in England. Medicaid and Medicare are forbidden by Congress to negotiate prices but N.I.C.E. in England can negotiate and does, as does the pan Canadian Pharmacutical Alliance. However it is only available in England as first line treatment of Stage 4, ER+ patients, so a lot of women on this site wouldn't qualify for Ibrance in England.
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Thanks for the additional information Hobbes.
What I’m trying to wrap my head around is the process for drugs to become available in Canada. As you mention, there have been ongoing negotiations regarding funding for Ibrance but in the interim it is available to those of us who can pay for it (either personally or through a health plan).
Another example is Fulvestrant which has been available here for a long time but is not funded. I noticed that it is currently under review for funding as a first line treatment for those who have not received any prior hormone treatment (and it appears the reviewers are still not convinced of the cost effectiveness even with a very small pool of patients who would benefit).
So, for me, the million dollar question is, when will Abemaciclib be available here under private plans? It’s amazing how naive we are until we are thrust into this situation.
Pat
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Enerva I was able to get a hysterectomy when a BC tumor was found in my ovary. It was supposed to be a laproscopic procedure removing the ovary but the tumor was too big or the doctor wanted to take everything out because when I woke up everything was done.. That was in June I also had mets to the spine, rib, hip and some cancer lesions in my belly. The surgeon told me he saw the other lesions in my abdomen but was convinced that the chemo would take care of that. Honestly in my laymen mind I wish he would've cut every piece of cancer out.
I was happy that I had the surgery because I felt so helpless with all that cancer inside and felt that my ovary was the heartbeat and feeder of the other tumors. The psychological impact of that is traumatic in and of itself. Best of luck and outcomes with your treatment.
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Pat: I can’t answer your question. I think but I am not certain that Eli Lilly would need to obtain a “notice of compliance” from Health Canada stating that the drug meets Canadian safety standards before you could purchase it here. As far as I can tell, Eli Lilly has not applied for a NOC from Health Canada. You could try contacting Eli Liily’s Canadian office to ask if and when they will apply for an NOC. The process to get an NOC can be 6 to 12 months. As I said yesterday, it is not unusual for this application to be made 1-2 years after the FDA grants approval. The BCCA can tell you if they would allow an oncologist to use a drug without an NOC. There are liability issues.
Where in BC are you?
Jo
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In Canada we are in an interval between the closure of compassionate availability of Ibrance, and it being funded. As far as I know, during this time interval, no new sales will be initiated, even for those under a private drug plan. My wife's private insurance will pay for it, but we had to make the deadline back in early 2017 before the door closed.
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An interesting report came out last month:
Researchers used sequencing to follow the evolution of cancer in four metastatic breast cancer patients as they progressed following their sequential treatments. Rather than showing an increase in the number of different cancer subtypes, all four acquired cells that were driven by tyrosine kinase signaling pathways- these cells were not prevalent before treatment, but were able to grow because they were resistant to the drugs the patients had taken. There are many tyrosine kinase inhibitors available, like Gleevec, and the researchers are now looking at samples from ongoing clinical trials to see if they can determine what drug combinations might hit this type of drug-resistant cancer cell.
From the report:
In lab experiments, treatment-resistant subclones from a patient who had developed resistance to the chemotherapy drug doxorubicin were highly sensitive to a combination of two different tyrosine kinase inhibitors, whereas cells collected from the patient before doxorubicin treatment were not affected at all by the drugs.
https://www.cancer.gov/news-events/cancer-currents...
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Interesting situation with Ibrance. My onc is considering putting me back on Ibrance in combination with Fulvestrant but I wonder if there will be issues accessing the drug. Hopefully not as my insurance company has already agreed to pay (and covered four cycles at which point I had to stop due to progressive anemia).
Jo, I'm in Victoria. I suspect that the BCCA would be unwilling to allow use of the drug prior to NOC but hopefully this will come in time. Thankfully Abemaciclib seems to work on heavily pretreated patients. Holding on to that!
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I am in Victoria too. I am down to 75 msg on cycle 6. I get Ibrance directly from Pfizer as my insurance refused any payment. The special access program was only open from Nov 1 2016 to May 312017.
Jo
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Small world.
If I do go back on it I'll have to drop to 75 mg as well. Should know in a couple of weeks. I'm on the 4th cycle of Xeloda and then we rescan in a couple of weeks. My body is sending mixed messages in terms of response to Madame X. Some things seem better and some... not so great. I'm really hoping to land on a treatment that works for a longer period of time. So far, I'm not responding as expected... I seem to be the opposite of an exceptional responder. :-(
Pat
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hi tanya. Thanks for sharing
I will call up my breast c surgeon on Jan 08 when she is back from her holidays. I want her to be the one to say surgery is not an option. I am very confused is just so unreal all that had happened. Thanks a lot for letting me know your experience
As per the drug. All I was told at the pharmacy is that my insurance company will have to cover it and that if not they will put me on another system which may provide but I didn't receive any calls yet so I am not sure what will happen.
My next appointment is Jan 04 2018. I guess I ll then know more.
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A new post yesterday from Constantine....all very encouraging!
A CHRISTMAS / HANUKKAH / HOLIDAY GIFT BASKET FROM SABCS 2017
The Winter holidays - rather quietly - brought some extraordinary holiday Cheer and Hope in the way of powerful frontier-edge advances in the treatment of all forms of breast cancer, for ER+ disease, and for HER2+ disease, and for TNBC, and for BRCA-positive breast cancers. Below I give my choices of the best of these, with some critical - and optimistic - commentary of my own.
Breakthroughs in Endocrine Therapy
I have already written about the breakthrough results in endocrine therapy (for ER+ disease) stemming from the FDA approval of the selective CDK4/6 abemaciclib (Verzenio): exceptional survival outcomes even in later stage metastatic disease in heavily pretreated patients, outcomes higher than any other agent used in breast cancer to date; high rates of response; durable survival benefits; its combination possibilities with aromatase inhibitors and fulvestrant and PD-1/PD-L1 checkpoint inhibitors among others. Al this following the impressive efficacy of two other FDA-approved CDK4/6 inhibitors, palbociclib (Ibrance) and ribociclib (Kisqali).
SABCS 2017 now brings us further promising benefits of combining abemaciclib (Verzenio) with the checkpoint inhibitor pembrolizumab (Keytruda), where the JPCE trial found benefit in pretreated ER+ disease without adding any additional toxicity. In addition, the phase II neoMONARCH trial found neoadjuvant abemaciclib (Verzenio) plus anastrozole active in early breast cancer, dropping the rate of proliferation (Ki-67) to below 2.7%.
In addition, the MONALEESA-7 trial showed that ribociclib (Kisqali) improves PFS by 10.8 Months in ER+ pre- and peri-menopausal patients with advanced breast cancer: the median PFS was 23.8 months for women who received ribociclib (Kisqali) combined with either tamoxifen or a nonsteroidal aromatase inhibitor (AI) plus goserelin (Zoladex), compared with 13.0 months for those who received standard endocrine therapy, highly significant results for the challenging group of younger-aged breast cancer patients.
Breakthroughs in HER2 Therapy
We also saw some significant advances in HER2-positive disease. The Phase IB/II PANACEA trial found that the combination of the checkpoint inhibitor pembrolizumab (Keytruda) plus trastuzumab (Herceptin) can achieve an impressive disease control rate (24%) in trastuzumab-resistant, PD-L1–positive, HER2+ breast cancer patients, potentially adding another weapon in our arsenal of effective anti-HER2 therapies.
In addition a new formulation of trastuzumab (Herceptin), namely trastuzumab deruxtecanwhich is a highly potent antibody conjugate (like T-DM1 (Kadcyla)) was highly active in heavily pretreated patients HER2+ metastatic breast cancer patients, with a exceptional durable overall response rate (ORR) of 61.4%, extremely impressive given that this was in patients who had already moved through some of the most potent HER2-targeted therapies including trastuzumab (Herceptin) itself, and T-DM1 (Kadcyla), and pertuzumab (Perjeta), and also impressive was a disease control rate (which includes stable disease) of between 84.2% up to 100%!
With an FDA Breakthrough Therapy Designation, I expect to see regulatory approval quickly, adding an exceptional exciting and powerful new agent to anti-HER2 therapies for advanced disease.
Breakthroughs in TNBC Therapy
In the challenging TNBC arena, SABCS 2017 brought us what I consider to be four breakthrough advances.
One phase 1 study of TNBC patients who were already heavily pretreated found that monotherapy with an antibody drug conjugate (ADC) biological agent, ladiratuzumab vedotin (SGN-LIV1A), showed encouraging antitumor activity in a with heavily pretreated TNBC, with a 58.3% disease control rate (including stable disease). This brings a targeted biological agent into the TNBC therapeutic context, rather than just chemotherapies.
In addition, the ENHANCE1/KEYNOTE-150 Phase IB/II trial found the checkpoint inhibitor pembrolizumab (Keytruda) plus eribulin (Halaven) delivered impressive efficacy in patients with metastatic TNBC, with disease control rate of 36.8% in this highly challenging population.
Still another immunotherapeutic agent, sacituzumab govitecan / IMMU-132 (another antibody-drug conjugate (ADC) achieved an objective response rate (ORR) of 34% in patients with heavily pretreated metastatic TNBC, and better survival outcomes than available conventional chemotherapies in this context.
Finally, the CALGB 40502/NCCTG N063H trial found that third-generation taxane, nab-paclitaxel (Abraxane) - one of my favorite drugs for metastatic breast cancer - shows promising improvements in both overall survival (OS) and progression-free survival (PFS) compared to standard paclitaxel (Taxol) for patients with metastatic TNBC, with a 26% reduction in the risk of death.
Breakthroughs in BRCA+ Therapy,
Two advances in PARP inhibitors continue to expand our regimen stockpile against BRCA-mutated breast cancer: the Phase III EMBRACA Trial found that PARP inhibitor talazoparibimproved PFS in BRCA-positive patients, impressively reducing the risk of disease progression or death by 46% versus chemotherapy. And the MEDIOLA Trial showed that a unique combination of the PARP inhibitor olaparib (Lynparza) plus the immunotherapeutic checkpoint inhibitor durvalumab (Imfinzi) elicits a disease control rate of 80% (!) for pretreated patients with germline BRCA-mutated, HER2-negative metastatic disease. These are truly breakthrough findings in the treatment of BRCA+ metastatic disease.
HEALTH | HAPPINESS | HOPE
TO ALL!
Constantine Kaniklidis
Director, Medical Research, No Surrender Breast Cancer Foundation (NSBCF)
Oncology Reviewer, Current Oncology [journal]
Society for Integrative Oncology (SIO)
Member, European Association for Cancer Research (EACR)0 -
Pat, mixed responses do a number on your head. Praying you get more guidance with your responses in your current treatment so you can plan your next move.
Joyner, I need to go back and reread your post, but first glance looks very promising. Thanks for sharing, we all need good news to start 2018!
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Joyner, I'm loving the latest update you posted. So much hope for all of us! Even though I've responded extremely well to Ibrance...about as close to NEAD as you can get without someone declaring it....my oncologist would like me to switch to Verzenio. We will decide in mid-January and the posts from Constantine will help me make up my mind. If the doctor would throw in a side of Keytruda, I'd be jumping for joy!
I continue my break from Ibrance begun when I got so sick from the Black Plague (flu?). I'm not brimming with energy as some of the lung infection continues but it's nice to have my brain feel more normal. I don't know that I've ever had any upper respiratory ailment last for five weeks but it is what it is! My husband has been calling me "the Shut-in". Remember when people went to visit the "widows and shut-ins"? I've been no place but the cancer center for a couple of months. I never pictured this being me! I'll miss our big family gathering in Birmingham tomorrow as the little ones have had the stomach flu and I sure don't want to risk another "thing". Life!
I wish you all a Happy New Year with the best health you can possibly have and loving people all around. PatG
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Sadiesservant, you may not have been an exceptional responder so far but your drug is coming. And you're certainly an exceptionally supportive friend here! PatG
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Ha! Pat, I had to laugh about your Black Plague comment. I joked with my oncologist that I have, so far, avoided the plague and pestilence running rampant through our office. We have had nasty influenza, serious colds, pink eye and Foot and Mouth! Needless to say, the traditional potluck, communal food thing held less appeal! While several dishes looked appealing, I was firm in my commitment to avoid any additional S#*t.
Wishing all of you a healthy, happy and fulfilling 2018. Pat (2).
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ISadieservent: i got a good response to Xeloda for 22 months. My liver Mets were still shrinking but there was progression in bone so I had extensive radiation and switched to Ibrance. My three month scan showed continuing shrinkage in liver and no activity in bone. I have another scan at the end of January. Other than fatigue and low neutrophils I have no SE. Ibrance is much easier than a Xeloda.
Jo
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Hello everyone.
I may have come down with my DDs cold in spite of everything I have done to avoid it. Here's hoping what I feel so far is as bad as it gets, and that you all stay free of this virus that is spreading. I wanted to wish you all a Great New Year filled with promising treatments and good news for you and your families.
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Hi Pat - why does your MO want to switch CDK4/6 inhibitors? Is she/he concerned about developing resistance, or side effects or what is the reasoning? thanks
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Hi Cure-ious,
He doesn’t want to switch but rather, is considering putting me back on Ibrance. Verzenio is not available in Canada yet. I had to stop Ibrance in August due to progressive anemia. Since then I had significant progression on Anastrozole alone and switched to Xeloda. We suspect the Xeloda may also not be showing a complete response. Scan after two rounds was deemed stable and we plan to scan again in a couple of weeks once my fourth round of X is finished (just call me sparkles - serious number of scans in the last year - I’m sure I must glow by now!).
My question here was about the availability of new drugs as Ibrance is not funded here but available. Abemaciclib may be a better choice for me given the blood issues. All speculation of course as I need to see the scan results but, like many of you, I like to think a couple of treatments ahead.
Pat
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Dear Joyner, thank you for the fabulous information from Konstantine you have just shared. Way to go !
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