Acalabrutinib

[bayside64]

Is anyone on Acalabrutinib? Is it ever offered before taking Ibrutinib?

[lankisterguy Volunteer]

I don't believe that Calquence/Acalabrutinib is approved for CLL (yet) only previuosly treated Mantel Cell Lymphoma. So a USA doctor would probably be reluctant to prescribe it off label and treatment naive, when Ibrutinib is nearly the gold standard for previously untreated CLL in the USA.

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Why do you want to try that route? Most people tolerate Ibru well.

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Len

[bayside64 in reply to lankisterguy]

Possible issue with Afib.

[Lily_Pad_Master]

Only in trials, but I believe approval is forthcoming.

[bayside64 in reply to Lily_Pad_Master]

I agree.

[bhayes84]

Yes. My doctor prescribed it when I had major skin problems on Ibrutinib. Acalabrutinib is approved for Mantle Cell Lymphoma so doctors can prescribe it off label. Ibrutinib followed the same path of MCL approval before CLL approval.

As others have noted here IB is well tolerated by most patients and in fact it clears CLL faster than Acalabrutnib. And Acala is also 25% more expensive than IB.

Good luck whichever way you go.

Bill

[GratefulOne]

I am on Acalabrutinib, but I am part of a clinical trial. It has not been approved yet for CLL.

[bayside64 in reply to GratefulOne]

Hopefully soon.

[Davemich]

Not sure if a doctor would be willing to prescribe it prior to trying Ibruitnib unless you have other health issues and are afraid of side effects. I am currently on Acalabrutinib after Ibruitnib was too toxic for me. Hoping it works as well as Ibruitnib. Best of luck to you.

[Bill1288]

I was on Imbruvica 420 mg for one year. It caused me to have Afib. Had heart Dr. and my oncologist work together and stayed on full dose. Then dose was reduced to 280mg due to severe leg and joint pain. Was on that dose 9 months. I went to see a CLL specialist a few months ago and he put me on Calquence (Acalabrutinib) starting May 1st. Doing well so far.

Bill1288

[bayside64 in reply to Bill1288]

Hope it continues to work for you.

[Bill1288 in reply to bayside64]

Still doing good.

Bill

[bayside64 in reply to Bill1288]

So glad to hear that.

[HopeME]

A quick search shows that Johnson & Johnson owns Ibrutinib and AstraZeneca owns Acalabrutinib. I assumed I was going to find that both manufacturers were the same but that wasn’t the case. If I am understanding this correctly, Acalabrutinib does everything that Ibrutinib does but with less toxicity, especially as it pertains to heart problems. So it seems that eventually the FDA will approve this drug and Johnson & Johnson’s business of selling the profitable drug Ibrutinib will plummet. I’m not certain how much it took to get Ibrutinib to market but I’m certain it was a lot. I guess this fact at least partially explains the cost of Ibrutinib. Are my facts and thought process correct?

Thanks,

Mark

[AdrianUK in reply to HopeME]

Hi. The logic sounds correct. But look at the example of Rituximab. It was the first CD20 antibody and as such there was a lot of experience using it. When another one came along which was more specific and hence should be stronger efficacy and better side effect profile you’d think that everyone would have switched to it. And yet they haven’t. The reason is because nobody did head to head studies to

Prove it works better. It may be for example that people will use ibrutinib but be offered the chance to switch.

Of course venetoclax is in the mix as well and so it’s possible that will take over the limelight from both the nibs!

Use of drugs is complicated and doesn’t always follow simple logical rules.

[larrymarion in reply to HopeME]

Mark, allow me to offer some corrections/updates to your comments. Ibrutinib is owned by Abbvie for the past several years. check this link: en.wikipedia.org/wiki/Pharm...

The original company that launched ibrutinib (pharmacyclics) was a small company that when it first launched the drug and did a joint venture with the jensen division of J&J for U.S. marketing rights. That JV ends in a few years. While J&J is enjoying probably $1 billion+ in revenues each year from ibrutinib, that amount is a really small part of its overall business.

Hemocs i've talked to this month say acalabrutinib will be approved for CLL by the end of this year. Note that Astrazenca, the owner of acalabrutnib, reported last year that 75% of the Rx for its drug were for CLL patients, not MCL. And Astrazeneca also reported that many of those CLL scripts were for treatment naive patients. Abbvie and Jensen/J&J won't lose much revenue from the approval of Ibrutinib for CLL because the vast majority of hemocs will continue to prescribe the first to market and because there is a lot more research on I. Also, the new indications/approvals for ibrutinib will continue to increase the market for the drug. Hemocs will only defer to acalabrutinib, or the other novel agents, when side effect issues arise.

also note that abbvie also owns venetoclax, which is soaring in use. Note that the parade of other anti cll novel agents will ultimately reduce the cost of these drugs, as more competition enters the market.

Another factor behind the pricing of ibrutinib is how much it cost abbvie to buy the company. The wikipedia note mentioned $21 BILLION, so Abbvie has to charge a lot to get a return on that investment. Ibrutinib is generating billions of dollars in revenues each year for the JV partners, way beyond the cost of developing the drug. That development cost was insignificant compared to what Abbvie paid to buy the company.

[schmitthj007]

I am on Acalabrutinib within a trial setting. Had headaches for 2 weeks but basically no side effects since except perhaps easy bruising.

There are several trials going on with this drug including head to head comparison with Ibrutinib. These trials will tell us how effective it is. From my point of view if it indeed offers less side effects with the same effectiveness it should be the preferred drug. Time will tell and obviously Ibrutinib got a huge head start with excellent data.

Regarding costs this is a very different story. One would expect that the prices come down with competition but this is not necessarily the case at least in the US.

[ReneeSusan in reply to schmitthj007]

Hi Schmitthj007, I will be starting Acalabrutinib soon, any advice? Wondering if you had fatigue or weight gain on Acalabrutinib? How did you deal with the headaches?

Wishing you well!

Renee

[schmitthj007 in reply to ReneeSusan]

Hi Renee

This is a great drug. The headaches disappeared after 2 weeks and I did not have any other issues except low platelets. Yes there was some weight gain but I also was on high doses of steroid (90 mg). I took Tylenol 500 mg and this took the edge off. Continued to work full time in a very stressful job and did not miss a day. So overall very well tolerated. Reading on the side effects of Ibrutinib I think acalabrutinib is much better tolerated. My lymph nodes disappeared within 2-4 weeks. Wishing you all the best

Heiko

[ReneeSusan in reply to schmitthj007]

So good to hear the lymph nodes shrink quickly. Mine are bothersome and the fatigue is making hard to get thru my work day, also very stressful! I am looking forward to feeling better and the old - new back. Thanks for sharing your journey.

Renee

[uihwki]

I've been on it since July 2018 (no trial). I didn't want to deal with the potential side effects of ibrutunib so I asked my specialist if she would prescribe it off label. She supported my decision and my insurance (USA) approved. Results have been phenomenal with minor side effects for the first couple of weeks.

[bayside64 in reply to uihwki]

Good to hear. Thanks.

[Waligunda]

I am on Acalabutrinib since two months. Not on a trial, prescribed by local hematologist in the US and approved by Dr. Kipps, my CLL specialist (UCSD). As Dr. Kipps said to me, the results are “spectacular” in my case. This is not a first line treatment for me. I have no side effects so far, that I know of. Medicare approved the treatment and my doctor managed all financial issues.

[bayside64 in reply to Waligunda]

That’s great to hear. Thanks.

[Dksmith71]

I’m on a trial for Acalabrutinib. Only side effect I had when started was severe headache for a week. Have been in trial for almost three years and have been in remission for 2-1/2 years! Was diagnosed stage 4 with 13q deletion.

My doctor says it should be approved soon. Feeling blessed!!!

[bayside64 in reply to Dksmith71]

How wonderful to hear!

[kimiD]

To those already taking this drug, thank you for all of the information. I saw Dr. Weirda at MD Anderson yesterday and I will be switching to Acalabrutinib as soon as they get the approval from my insurance company. Ibrutinib was still giving me too many side effects, even after 2.5 years.

[bayside64 in reply to kimiD]

Thanks for responding. Good to hear that you will be starting Acalabrutinib.