Nerlynx Approved by FDA to Treat Early-Stage, HER2-Positive BC
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I believe if you are more than 2 years out from Herceptin you don't qualify to take Nerlynx.
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@suemed8749 - thank you! I'm the first to take outside the clinical trials, and I have no diarrhea! Stopped taking the Imodium. I'm going to search for that thread.
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@edu it won't let me post a link. It's Nerlynx Neratinib support group. It's the only one there. You can also search for me and friend me if you want.
(Edited by Mods to delete member's personal information. We strongly recommend not posting personal information on a public forum, for your own privacy and security. Please exchange contact information using the Private Message feature.)
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Found it!
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I'll be seeing my MO this week and will ask her about this Nerlynx.
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I was in the clinical trial years ago. I made it about 4 months. The diahrea was ridiculous - just constant. They prescribed loperamide, to relieve and that did help a little. They also reduced my dosage after a bit. They were trying to find toleration levels. I got dizziness and cold sweats too. I am glad I did it as long as I did though from the outcomes involved.
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geewhiz, sorry to hear that, but thank you for participating in the trial.
Was the SE worse than if you did Herceptin with Perjeta in your chemo phase?
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yes indeed many thanks to the ladies who participate in clinical trials and pave the way for the rest of us -- much respect
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Hi all,
I spoke to my MO yesterday and asked about this drug. She indicated that she was just starting one of her patients on this drug. She said that I would also be a good candidate given my history and that she'd revisit it in December when I completed Herceptin.
Has anyone here actually started taking this drug?
~Dee
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does anyone know if it's two years after the END of herceptin, or two years after the START of herceptin? I completed in June 2016, but started June 2015...wondering if I would qualify?
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I discussed this drug with my mo at my followup appointment this week. She did not think it was appropriate for me for several reasons.
- She thought the trial did not include women who received perjeta.
- The results were very modest.
- The side effect (diarrhea) was pretty severe.
The center she is at had some patients in the trial so she was very familiar with the drug. From doing a Google search, it looks like this drug is going to be very expensive just like herceptin/perjeta. Also, I think it is a daily pill which for me would mean it would be covered under my prescription plan rather than my regular health plan (ie more money out of my pocket).
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This FDA site indicates the trial was based on women who were within 2 years of completing Herceptin.
Women (n=2,840) with early-stage HER2-positive breast cancer and within two years of completing adjuvant trastuzumab were randomized to receive either neratinib (n=1420) or placebo (n=1420) for one year.
I also ran across this, with discussion as FDA was looking at whether to approve the drug.
https://www.forbes.com/sites/matthewherper/2017/05...
Seems to be most support for within 2 years and HER2+/ER+ with bias within that group to node-positive more than node negative patients? But a wide range of opinions and the drug approval doesn't seem to have had narrow restrictions on population that could try it.
Not that I could do a comprehensive search, but not easily finding any discussion of Perjeta in in direct context of the Nerlynx study. This article has a mention trying to compare the results of the Nerlynx study against a different study which had Herceptin + Perjeta used adjuvantly. Seems to suggest the results were comparable or slightly in favor of the Nerlynx result, but difficult to directly compare given differences in the studies, patient groups, etc.
Interesting reading but I guess as always it gets to talking with your medical team on your specific case. Personally I seem like a possible but not slam-dunk case if you ignore the Perjeta question mark. Took TCHP, finishing with Herceptin next week; was strongly ER+; but node-negative. This was my second BC situation, so I'd be inclined to take whatever to prevent recurrence and see how the SEs fare. Sticking with it in the event of week after week of strong diarrhea would be formidable, but I had some of that with TCHP (probably Perjeta?) and made it through.
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Does anyone knows if this drug has been approved in Europe aleady? I live in Brussels and don'tsee my oncologist until October
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My onc spoke to me at my last treatment. Right now, she does not think the side effects outweigh the benefit in my case because I am not ER+, only PR+. She wants to see more research first. I just started Herceptin in March, so if the window is 2 yrs (from start? from finish?) I have some time. The thing that makes me pause is that she is all for me taking Tamoxifen as a PR+ only person because she says the PR will mimic ER. If that is the case for hormonal therapy, then it should also be the case for this drug as well, I would think.
She will keep me informed on what she finds and thinks.I just missed Herceptin the last time I had breast cancer and I will always wonder would it have recurred if I'd have been diagnosed after Herceptin became standard.
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Man, I am so on the fence now about this. I saw my onc today to talk about this, and even though I am a candidate for it (kinda just barely due to the length of time it's been since H&P), she said the side effects can be crazy debilitating, and that it may not be worth that for such a modest benefit. Also, along with the Nerlynx they give you essentially Imodium which you have to take 3 times a day (!), and she also said due to the chance of liver toxicity you have to be monitored for that every few months in the beginning. Basically, she said she supports me if I feel strongly that I want to do it, but medically she's not strongly recommending it due to the aforementioned reasons. I am leaning towards no because it sounds like a pain in the ass (literally and figuratively), but I hate to leave a tool out of my toolbox, so to speak. I just don't know.
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How long do you have to take it for? One year
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HI All,
Puma Biotechnology has patient communication material about the newly approved drug NERLYNX . They are looking for people currently on Herceptin to review this 3 page communication and answer the questions below. However, the document is still confidential, so all who review (including us) need to sign a confidentiality agreement.
If you are interested, please PM us and we'll get you the confidentiality agreement, and the document.
We, and Puma Biotechnology, greatly appreciate your help with this!
Best,
The Mods
Some of the feedback questions that they would be interested in receiving are the following:
- Is this language simple enough to be understandable? If not, what specifically needs to be simplified?
- Is there anything we're not explaining fully or clearly enough?
- Are there any messages missing?
- Are there any messages that are unnecessary?
- Are there any messages that raise questions for you?
- Are the messages in Stage 1 hitting the right tone and providing the right information for women who are just diagnosed/just starting to plan their treatment?
- Are the messages in Stage 2 hitting the right tone and providing the right information for women who are just finishing their Herceptin therapy?
- What is the best term to use with care partners when referring to their patients/loved ones?
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Magnolia - I'm one of those people that this drug might not have little effect on (er/pr-) but I'm starting today. Worst case scenario the side effects will be too much and I'll quit and.... oh well. The way I see it, there's no harm in at least trying. With the blood test they'll see if the liver is getting affected and you can always quit. The liver is usually pretty good to repair itself. Who knows, maybe I (or you) will be one of the folks that handles the SE's just fine? I'm gonna give it a try. Also, as far as cost, my insurance covered it 100%.
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PezGal, let us know how you're doing on Nerlynx.
I had a followup with my MO today and asked her about Nerylnx. She said from what she knows so far, she wouldn't recommend it for me because it doesn't appear to be very effective for ER-/PR- and the SEs can be rough. My last Herceptin is 10/20/17 so there is plenty of time to decide.
I have mixed feelings. I'm glad that treatment will be over soon, but I'm also afraid of not having any more treatment.
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My MO was thumbs down on Nerlynx. She said she couldn't believe the FDA approved it, and that the side effects are horrible for not much benefit. She also pointed out that the long term safety profile is just too uncertain. She she was a no for me taking it.
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Anyone taking this drug? How are you monitored for problems? How long will you be on it? Do you take Tamoxifen as well?
I still have Herceptin through December and not sure if I want anything else. Just recently got around to starting the Tamoxifen! But always thinking about the future ...
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I am on the fence too. My onc feels I should take it and she stayed if I were her relativeshe would tell me to take it also. I am only HER2 + (ER/PR -) . She feels that this is more beneficial since I am ER-. I finished herceptin and perjeta in January , 2017. I am worried about the diarrhea
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I haven't started the drug yet, but I do have it on hand. It gets shipped to you from a specialty pharmacy. I am not starting for about 2 weeks due to a couple big trips that I had planned. I understand the skepticism since we have all been through so much & don't feel like going down the side effects path again. Also the newness of it. I am putting my game face on and will go for it. 34% seems like a big number for me (and I know people doubt those #'s, however those of us with the drug got a nice big welcome pack which included explanations, as well as the clinical trial data). And worst case scenario, if it affects my daily life horribly - I will stop. From what others are saying on other groups, its doable. First 2 months are the worst as your body adjusts, but most people have said the continue as normal working, being a Mom, etc etc.
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I didn't answer some of the questions that I meant to! My MO said that he was looking at patients who were within 1 year of Herceptin completion. I believe it had to do with how the study was run, as insurance was re-imbursing based on study guidelines. He felt that as time went on, that this 1 year timeframe might relax. Also you take Nerlynx for one year, and yes you continue your tamoxifen or AI (I am on tamoxifen).
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"And worst case scenario, if it affects my daily life horribly I will stop" - that's my feeling if my MO agrees I should try it. Having been through versions of BC twice now, I'm not feeling overly lucky to avoid another round eventually - open to most any reasonable idea that might cut down the odds.
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Yes Misslil - thats how I feel. The fear is always there - sometimes in the back of your mind, sometimes a lot closer to the front.
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My next door neighbor had two rounds of BC and talked with me about it when I had my first diagnosis. Sadly, she had a third situation arise and despite treatment is no longer with us. Having seen that unfold right next door, I'm afraid that contingency is always somewhere in my mind. Along with my getting BC again despite aggressive treatment of DCIS originally (mastectomy with radiation), and getting a gyn pre-cancer that might have been an uncommon side effect from tamoxifen.
It's hard to know what causes what in any individual case, I think. But my overall history and seeing cases like my neighbor makes me want to have a hard look at trying the Nerlynx. Plus continuing to talk with the dr teams about getting an MRI every year even if I have to pay for it (alternating with mammogram if it were up to me so I'd get one scan every 6 mos).
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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.
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Thank you for being one of the brave people who go on trials tadover. I appreciate you so much!
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