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

I was in the clinical trial for this drug and I took my last dose in mid February. I took it for a full 12 months and was tested thru out that time. when I first started taking it I was on the full dose of Imodium and then tapered off of it. I really didn't have too many episodes of diarrhea and was actually glad to be able to stop taking the Imodium when I could. I felt that I could at least try it and stop if I needed to. And I felt that it might not necessarily help me, but hopefully it would someone else in the future. I was and still am on Femara and feel like I have more side effects from it than I had with the neratinib. I wanted to say I at least tried whatever I could to prevent it from returning. now it's just a wait and see.

So I went through the process of getting and taking Nerlynx after it received FDA approval. I heard about the drug receiving FDA approval so I brought it up with my onc. She told me at my stage she wouldn't recommend it due to the side effects, but she would let me do what I felt like I needed to do. I have recurrence anxiety so I decided I would try it. My philosophy during treatment is that if my cancer came back wanted to be able to say I did everything I could to fight it. I thought if the side effects get too bad I can quit. I obtained the drug through Walgreens specialty pharmacy. So I took it on a Thursday. As someone mentioned you have to take the Loperamide three times a day to go with Nerlynx each time you take it. the first couple of days I was fine. I was like this won't be so bad. Then the six day came, and it was awful. When I say everything ran through me, everything ran through me. My body wouldn't hold anything. It was violent diarrhea. It was so bad I was worried I was becoming dangerously dehydrated and might have to be hospitalized. I can't say I wasn't warned about the side effects, I just thought with the Loperamide they would be manageable. I should say I've had diarrhea before numerous times. This was a million times worst because it was un-treatable for a couple of days after I quit Nerlynx. I basically decided to quit the medicine, which my onc agreed with. Everyone has to do what's best for them, but for me those side effects weren't worth it. I'm hopeful that my treatment protocol was enough to keep my cancer at bay. I just wanted to give my perspective since I did take Nerlynx, albeit for a week lol. Maybe I'm an extreme outlier but this medicine was worst than anything I experience while undergoing chemo. I think it's awesome this drug is a new tool in the arsenal for battling HER-2 positive breast cancer, I just wish there was a drug with less strenuous side effects.

Ding dong here - I now see the Herceptin under Targeted Therapies... So sorry for the confusion Nclark

LKC,

Can you shed some light on the quality of life for the patients who had to manage the major side-effect of diarrhea. Do you have any patient stories?

Hi! Following this is as my onc has mentioned this Med to me. Curious how other ER- folks are being advised? Is there anyone hormone negative who is now taking this and what is your onc saying about the study results?

Thanks

Guys, so thankful for this thread. Synopsis, my DD has stage IV ER+PR+HER2+ FISH positive Her2neu. She is 33yrs old, a young mom. I am at the stage IV thread mostly, she is very assertive and lively young woman, but does not wanna deall with this monster details, so that's where i come in. She totally depends on me to get her on the right track.

She was on most treatments i'd say, even being on 2 trials this year already. Last week she had Hematuria, grossly ignored and mismanaged by her doctors and Hospital, but because of her symptoms after much suffering they ordered a CT and then they saw progression from just 3 weeks ago. They were able to cauterize the area, they took a biopsy they said it's a benign Hemangioma. She is off that trial. Onco left her high and dry, this is a chapter on it's own.

Current homework and hopefully new doctor, is recommending Neratinib. Actually they mentioned it would be on it's own, not with Herceptin. She has been on Herceptin for over a year at least, till June when she entered this new trial. And Xgeva. She is scheduled for a new PET/CT this week and Brain Mri. Her mets are in the brain also. Maybe maybe they would look into Keytruda instead. Was anyone here, that was offered Neratinib also had maybe a chance to be on Keytruda and opted one over the other?

I sure hope the Insurance won't give it hard time to confirm. I am very freaked out - BTW for you ladies that were offered this drug, is this something that is being offered sooner than in treatment, and not waiting for it to be a salvage tx?

The former Onco is not even bothering to follow up, my DD is so stunned that as soon as the heat is on, they are running away. Shame shame

Tadover thanks for being in the trial – good luck for u

Nclark, thanks so much for the heads up, so sorry it was so hard for u. What could be the right dosage for lomotil?

Knmtwins u made me laugh!! Big D or little d. Graphic is important, it's the reality, and it could help others.

I only read the last page so far, any info is gonna be great. Thanks.

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momallthe time - Neratinib is an FDA approved drug, which has now been approved to be given to early stagers after completion of their year of Herceptin - thus the announcement by the Mods and this thread.. The way it is administered for stage IV patients could be different and possibly in conjunction with other targeted therapy or chemotherapeutic agents. I am sure hoping it does some good for your daughter and that you can get the doc situation straightened out for her - you are doing a great job in difficult circumstances. ONT-380 - or Tucatinib - is an investigational drug, but has not been fully approved yet and is still in trials. Like neratinib, it is also a tyrosine kinase inhibitor. Here is some info on it:

https://www.sciencedaily.com/releases/2017/01/170111091449.htm

hi--i asked my oncologist about neratinib. She said that she isn't giving it to ER negative patients and the benefit is for ER positive patients only. Please let me know if the oncologists of any ER negative ladies is saying that it gives ER negative ladies benefit --if so, i will ask my oncologist again with this information

Thank you all ladies for sharing your experience

I am ER-. My oncologist is part of the trial study team for this drug. She has recommended this drug as being beneficial to reduce my risk of recurrence

If you haven't already, join the FB Nerlynx group.  Hope to see you there!

I met with my MO today for a 3-month followup after my final Herceptin treatment. He did not mention Nerlynx but I asked about it. It took him a minute to recognize what I was asking about. He described it as having just come into approval within the last couple of months. He did not have any patients taking it yet but recalled hearing that it may be beneficial.

We left it that he's going to research it more and we will talk early next month.

Misslil. I agree with you. I had BC 18 years ago, her2 neg. here I am again. Her2 positive this time. I am a nurse, my chemo nurse is two years post diagnosis, same diagnosis as mine, meaning stage, etc.She is taking nerlynx and I will too. She gave me a heads up on the diarrhea. I am a visiting nurse without access to a bathroom for immediate need. I will at least try nerlynx. I do well in the SE department so I will hope for the best. I also had precancerous issues due to tamoxifen. I feel the need to take whatever I can to not face round three! One is enough for anyone.

Tadover thank you for participating in the trial.

BTW - Along with lots of other people, I don't so Facebook either. Thanks to those of you who are keeping the discussion going on the BCO threads.

Kim: Thanks. Sounds like it's a better fit for those who are ER/PR positive. I too had a recurrence. That definitely makes us look at things differently. I did the first 6 rounds with Perjeta included and lost 60 lbs due to diarrhea. When do you finish the Herceptin? Please do keep us in the loop as you make your decision

Minustwo, yes, I agree with you about Facebook and appreciate the posts on BCO.