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Nerlynx Approved by FDA to Treat Early-Stage, HER2-Positive BC

moderators
moderators Posts: 7,666
edited January 2019 in HER2+ (Positive) Breast Cancer

Nerlynx Approved by FDA to Treat Early-Stage, HER2-Positive Breast Cancer
July 18, 2017

Nerlynx was approved by the FDA on July 17, 2017 to treat early-stage, HER2-positive breast cancer for an extended period after surgery in people who have previously been treated with Herceptin. Read more...

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Comments

  • Magnolia83
    Magnolia83 Member Posts: 20
    edited July 2017

    This is really interesting! Has anyone here used Nerlynx? I'll have to do some more research but I completed Herceptin about a year ago, wonder if I'd be eligible for it? I'll have to read more about it and ask my oncologist!

  • Magnolia83
    Magnolia83 Member Posts: 20
    edited July 2017

    Thanks KB870! That was very helpful. I just emailed my doc about it!

  • cross_fingers
    cross_fingers Member Posts: 2
    edited July 2017

    I've read some info about this drug, and it states that it is approvedfor early stage cancer. I was triple positive, stage IIIB, and finished herceptin 4 months ago. Does anyone know if stage IIIB is considered early stage? I think I've read that IIIB and C are not considered early stage. Not sure how the drug manufacturer is defining early stage.

  • BarredOwl
    BarredOwl Member Posts: 261
    edited July 2017

    Hi cross_fingers:

    The following is not a statement about what is or is not included in the term, but is only my layperson view that Stage IIIB may be included in this case.

    I agree that "early stage" may mean different things in different contexts. I do not see a clear definition of how the term is being used in the FDA label for neratinib (Nerlynx). A possible suggestion that the meaning of the term here may differ from other situations includes the broad reference to "Stage III" in the FDA label, rather than a particular substage(s).

    In addition, the inclusion criteria for the ExteNET trial on the clinicaltrials.gov website indicate that patients "through" Stage "IIIC" were included in the study population.

    I do not have a copy of this, but the full-length trial publication and/or Supplementary Material available on-line might include more details if you have access or can purchase full access:

    >> Chan (2016): "Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial"

    >> http://thelancet.com/journals/lanonc/article/PIIS1470-2045%2815%2900551-3/fulltext

    Regardless, it would be worth making an inquiry with your team to ensure you receive accurate information from a professional. Because there may also be timing considerations, please promptly contact your Medical Oncologist to discuss whether this may be an appropriate option for you to consider.

    BarredOwl

  • lkc
    lkc Member Posts: 179
    edited July 2017

    Hi all, I actually worked on the ExteNet study , and enrolled a number of patients on it. The criteria was early stage as defined by stage I through stage III..

    If anyone has any questions, I will be happy to share as now the trial is completed and the results are public


  • elainetherese
    elainetherese Member Posts: 1,625
    edited July 2017

    lkc,

    I read a summary of the study and it said that 40% of the Nerlynx recipients suffered from "severe diarrhea." Were most of the affected patients able to control that diarrhea? How was "severe diarrhea" defined?

    Thanks for any insights you can offer!

  • BarredOwl
    BarredOwl Member Posts: 261
    edited July 2017

    This appears to be addressed by Antidiarrheal prophylaxis. For more, see for example, the section "Dosage and Administration" and the section "Warnings and Precautions" at page 1 of the current FDA label:

    https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208051s000lbl.pdf

    By the way, the inclusion criteria were amended several times during the course of the trial, somewhat muddying the waters for the layperson. In addition, in general, the inclusion criteria and the ultimate approved indications may or may not be coextensive, depending on exclusion criteria and the actual data available for various groups or sub-groups.

    I would encourage those interested to consult their Medical Oncologist.

    BarredOwl

  • lkc
    lkc Member Posts: 179
    edited July 2017

    yes, diarrhea was the most common side effect. The study was amended to add a regimen to prevent diarrhea once the patient started the drug.

    There was a also an allowance to dosedown depending on the severity of the diarrhea.

  • sunnyjay
    sunnyjay Member Posts: 143
    edited July 2017

    I was just talking to my sister about this drug since she works for the mfr, and they are so excited to get it released! Because they are a small co and don't have their name out there yet, please discuss this with your MO. This sounds huge for Herceptin users!

  • moderators
    moderators Posts: 7,666
    edited July 2017

    Some more info for you all:

    Find out more about this new medication on the Nerlynx section of Breastcancer.org.

    We hope this helps!

    --The Mods

  • Tara17
    Tara17 Member Posts: 150
    edited July 2017

    lkc --did this study include subcentimeter node negative patients? I am grateful that i had subcm ddisease but what I found was that women like myself were excluded from almost every single her 2 agent study --except for the APT study ( a phase II study ) , there isnt any study that has included this population, so wondering if this is even a question to raise with my oncologist

  • lkc
    lkc Member Posts: 179
    edited July 2017

    the particular non metastatic study included women who finished their BC treatment and did not have any residual disease.

    The purpose of the trial was todetermine if this med prevented recurrence.

  • beesie.is.out-of-office
    beesie.is.out-of-office Member Posts: 1,435
    edited July 2017

    KB870,

    From my searching, it appears that there is an approved patent in Canada for the "Treatment Regimen Utilizing Neratinib for Breast Cancer" http://www.ic.gc.ca/opic-cipo/cpd/eng/patent/27557...

    but there is no reference to Nerlynx / Neratinib on the Health Canada site, either on the Approved Drugs list:

    https://health-products.canada.ca/dpd-bdpp/dispatc... (enter 'Nerlynx' as the Product Name or 'neratinib' as the active ingredient)

    or on the Drugs Under Review list:

    https://www.canada.ca/en/health-canada/services/dr...

    That's all I can find, so it might be that the manufacturer has not yet submitted Nerlynx to Health Canada for approval. Someone else might know more.

  • dccancer
    dccancer Member Posts: 9
    edited July 2017

    lkc - i was reading that Nerlynx was much more effective on Hormone positive patients. Is there any detail on how much more effective it is for those of us who are triple positive? I was diagnosed Stage II, negative nodes and had a pathalogic complete response to the neo adjuvant TCHP treatment. My MO said my recurrence risk right now is about 20% so i'm trying to find out how this might impact that number.

    Thanks!


  • lita19901
    lita19901 Member Posts: 176
    edited July 2017

    Ho, hum. Just sitting here waiting to get my pathology report... and in trying to decipher all the little abbreviations under everyone's posts mean I have come to realize that some of you with relatively recent diagnosis are getting Perjeta and some are not even factoring out size, nodes, stage, etc. And so I'm wonderingly how come

  • wellshoot
    wellshoot Member Posts: 21
    edited July 2017

    My MO mentioned this to me last week. He wants me to start soon. I am four months out from my last Herceptin treatment and he says it is perfect timing. I will be his first patient taking this. In fact, I think I will be the first in this regional cancer facility. I'm a little nervous but I know I will take it as soon as it gets approved bymy insurance. Has anyone else started this?

  • misslil
    misslil Member Posts: 229
    edited August 2017

    I have an appt with my MO on Weds, planning to ask him then.

    August is my last month on Herceptin, 2 more treatments to go.

  • lkc
    lkc Member Posts: 179
    edited July 2017

    the study collected the hormone receptor status on the participants, however I am unaware of any differential between the 2 groups

  • Pipandor
    Pipandor Member Posts: 130
    edited July 2017

    Hi Lkc and thanks for the offer. I read a few articles and watched a few (On live) videos about the trial that led to the FDA approval of neratinib. One of the conclusions, I seem to recall is that the difference in DFS survival, with or without, is minimal, especially for hormone- negative HER2 bc. Do you have the data on that?

  • lkc
    lkc Member Posts: 179
    edited August 2017

    The DFS rates revealed 93.9 for the study drug and 91.9 for placebo.

    And to amend my earlier remarks er pos women did have better responses then er neg.

    Note needs to be taken that the response rates were not stratified depending on the stage at enrollment.

    Hope this helps.

  • pezgal
    pezgal Member Posts: 12
    edited August 2017

    So, I looked at the results and it seems like DFS is WORSE for HR negative folks. I wanted this, even with the poop fits, so bad. Are the side effects worth it for HR- people? Anyone know? Ikc?

    image

  • Mommato3
    Mommato3 Member Posts: 468
    edited August 2017

    Please let me know if I'm reading this chart right. DFS at 24 months: 95.8 for 1-2 years out from Herceptin and 95.7 for Placebo. Does this mean that there really isn't any benefit if you're farther out from Herceptin treatment?

  • lkc
    lkc Member Posts: 179
    edited August 2017

    pez gal, yes the DFS w better for the hormone pos particiipants, BUT the hormone neg were not that far behind.

    And yes Mommato, you are reading the chart correctly.

    her2 BC tends to recur quite quickly so, the longer you are out the better the prognosis.

    No easy answers , I am afraid.


  • Mommato3
    Mommato3 Member Posts: 468
    edited August 2017

    Thanks Ikc. I had my appointment with a temp MO yesterday. He said he didn't see any benefit for me since I'm already 3+ years out.

  • Chris2566
    Chris2566 Member Posts: 6
    edited August 2017

    hi, I was the first one to start this drug outside of the clinical trials. The one pharmacy that carries it told me this when they fed exed the drug to me. I began 8 days ago. I was stage 3, ER+, IDC. I finished Herceptin October 2016.

    I started a Facebook group called Nerlynx (Neratinib) support group. Please join if you start the drug. I have had some mild side effects so far. Thanks. Christine

  • moderators
    moderators Posts: 7,666
    edited August 2017

    Dear Chris, Welcome to the community and thanks for sharing your story. Keep us posted on how you are. We hope to see you around here. The Mods

  • Edu
    Edu Member Posts: 12
    edited August 2017

    ladies, I start Neratinib tomorrow! my insurance approved it in less than a week and the pharmacy shipped it overnight. Christine, I can't find you on Facebook, can you send a link

  • Tara17
    Tara17 Member Posts: 150
    edited August 2017

    chris --what i read is that diarrhea is a significant issue with this drug. If you dont mind, can you comment on if you are having this side effect and if you are taking anything preventively for this ?

  • bareclaws
    bareclaws Member Posts: 246
    edited August 2017

    Please keep this topic current here. I've seen other groups, like my chemo month group, abandon this site for Facebook. (I'm not on Facebook.) Weneed this information!

  • suemed8749
    suemed8749 Member Posts: 210
    edited August 2017

    I was in the clinical trial for this drug, and I always suspected I was in the placebo arm since I didn't have any side effects (my onc eventually confirmed this.) We participants had a thread here - search Neratinib Clinical Trial and you can read through the posts discussing the side effects. Never before or since have I been so jealous of people having issues with diarrhea! Winking