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

I'll have to see of course what my MO says. My thought on the D issue is if that happens with me, it may be controllable based on what the study results seemed to show. Or worst case I could drop out of the drug.

I'm meeting with my MO in early December. One thought that has occurred is trying it around the holidays (I know, lol ugh) where if I have D issues I'd be more at home than at work, and able to experiment to see if I could get it balanced between the drug and imodium or other recommendations. I did have D issues during TCHP especially the middle rounds, it tapered off toward the last couple treatments. It was not great, but it was mostly in the mornings and did not affect me if I went in late to work after taking some extra time at home to get through it.

One goal in 2018 is to travel as I was not able for a year going through all the BC steps. With this is if it does induce D episodes, am curious if you could you take a break from it for a week or two then resume later. Would that mitigate the D for important times, would it breach the effectiveness?

Looking at the Forbes paper and quotes like this: "The question for patients with early-stage HER2+ breast cancer is if it's worth taking a treatment (Nerlynx) that lowers the risk of distant recurrence by less than 2% at 5 years, and which has not yet been studied over the long term."

If you think you are in the 90% who are fine after 2+ years - the improvement probably seems marginal. If you think you have a significant risk of being in the 10% bad luck situation, the improvement benefit strikes me as a lot better. If 10% have odds to recur with invasive disease and that reduces by 2% in absolute terms, it's a 20% reduction in the unfavored group. And then some subset of that risk is "distant recurrence" which would extremely serious / life-threatening, so the chance to reduce risks of that outcome would be very valuable.

Or am I looking at this wrong.

I met with my MO earlier in the week to discuss Nerlynx. He recognized the reports are showing a benefit but was little skeptical of its long-term benefit as the published results don't go out to 5- or 10-year histories. He also talked about the side effects, of course. And the price, which is around $10,000/month similar to what i saw for individual doses of Herceptin or Perjeta.

Given my history, we decided he would submit it to my insurance and see if they'll cover it.

One thing he mentioned that I didn't recall hearing before is that this is in pill form but you take 6 pills a day? He wasn't specific if they have to be spread out every so often, or you gulp a big pile o' pills at a time?

thanks, wellshoot. How has it been going for you with the Nerlynx treatment?

This past year, I max'ed out my insurance cap on co-pays/deductibles in January lol - courtesy of the big bill for a Herceptin treatment and some smaller things thrown in for fun.

I'm pretty much resigned one way or another that may happen again in 2018, and budgeting for it. Would like to be wrong.

If Nerlynx gets approved, assuming I'll have another quick buyoff on the max copays to cope with in early 2018. Or maybe a "free' round if the first doses get charged this month when I'm long since over the 2017 cap.

I have done fairly well on the drug. I am on my fourth month and I may have had four or five “bad” days. I take an Imodium and then I’m fine. My insurance has covered it but I think the drug company has a coupon program to reduce the cost dramatically.

No big problems with my insurance but a little back and forth on paperwork before I got the Rx shipment yesterday. Debated waiting for an appt with my MO first, but they were hard to schedule with given the holidays. Decided to bite the bullet and take the first dose today so I''ll have a week to see how any SEs develop before I'm due back on a full work schedule the Monday after New Year's.

From the instructions, it seemed that it could be 8 days before significant D reactions occur? Would be interested what anyone else's experience has been taking this together with the Imodium precautions. I'm hoping it's not too bad or will settle down in a few weeks as I have travel plans toward end of January.

Someone I know was diagnosed HER2+ shortly before I was, and we've been tracking through roughly similar treatment plans. Her doctor strongly recommended she do the Nerlynx but she hasn't started yet.

I saw just recently some 5-year results being discussed, which seem to hold up reasonably well (?) for the idea to take this drug. When I saw my MO, he'd raised concern with just 2 years or less of data that longer-term the benefits might fizzle out. I don't get that impression reading the study summary.

http://www.onclive.com/web-exclusives/longterm-data-published-for-neratinib-in-her2-breast-cancer

Thanks - I was reading something about the different sub-groups, wasn't sure how to interpret it where any of us may cross into more than one of the groups. The hormone positive group seemed to fare relatively well, the node-negative results not as great and I fit into both categories ...

I'm thinking I will plug away at this unless the SEs become too severe, as I've been treated BC twice now (DCIS back in 2008 and HER2+ IDC found in 2016). Not at all keen to push my luck with a third incidence.

I am very interested in reading all of the information that you all have written.  My doctor wants me to take this when I am done with Herceptin.  

From the small mountain of literature attached with my package, it did seem to suggest highest benefit if you start Nerlynx within a year after finishing Herceptin, and with a significant wait the effect (on average) can be considerably lessened. How statistically meaningful the latter data is, I'm not sure as the sample size was much smaller for the >1 year group. Always best to ask your medical team. Now that it is becoming better known, I'd guess that starting it not long after Herceptin finishes will become fairly common?

This was another article I found today. I assume since it's from the manufacturer's data it's not as verified as the clinical trial but some stats on taking Imodium upfront in the process. It looks encouraging if you take the preventives, and can stick the treatment out over the first month, it gets a lot better from there. Hope so, anyway.

https://www.fiercepharma.com/pharma/puma-s-neratin...

All my admiration and appreciation to those who took this in the clinical trial phase without any mitigating treatment -- it must have been rough.

here we go :

http://www.ascopost.com/issues/december-25-2017/ne...

Thank you Brave for telling me your thoughts. I think we'll contact our breast centre. Bevorehand, I'll have to discuss that with my daughter. Wishes to you.

Suburbs, me too! Hope we fare well.

Please do let us know how this new treatment goes.

my oncologist says he will be putting me on this when I'm done with my 17 herceptin treatments. He was first looking at perjeta but because my nodes were clean he said showed better results.