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

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!

@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.

@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.)

I'll be seeing my MO this week and will ask her about this Nerlynx.

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?

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

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?

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.

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.

How long do you have to take it for? One year

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%.

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.

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

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).

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.