acalabrutinib gets Breakthrough Therapy Designation for CLL from FDA

[avzuclav]

astrazeneca.com/media-centr...

Hopefully FDA approval will follow within a few months. When V+O got the BTD in March 2019, it was approved in May 2019.

I miss Chris/CLLcanada because he was such an expert on these processes.

[Indolent]

Great news! This should give us some options. And given acalabrutinib's fewer side effects, this makes ibrutinib the less desirable option. Competition is wonderful!

[Jonquiljo]

Basically Acalabrutinib is now going to be accelerated through the approval process because of it's extremely good results in ongoing clinical trials. Or (from PR newswire ..)

"An FDA BTD is designed to accelerate the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results which may demonstrate substantial improvement on a clinically-significant endpoint over currently-available medicines."

So yes, it's likely to get FDA approval in the late fall or early winter. The statement from PR newswire above would indicate that it's patient tolerance and performance is even better than Ibrutinib. Someone else more familiar with the Acalabrutinib trials should chime in here .... Has that even been tested?

[nvp815 in reply to Jonquiljo]

I participated in an ibrutinib vs acalabrutinib trial in 2016. I was put into the ibrutinib arm but I only lasted 10 days, as the ibrutinib caused bleeding (I was on Xarelto at the time). I had to pull out of the trial because it did not allow crossover to the acalabrutinib. Don't know if those trial results were ever published or even if the trial is complete. I should look into that when I get a minute. Happy to say, I actually started acala off-label in January 2018 and have had fabulous results. So happy it will available to more patients soon.

[Fulart in reply to Jonquiljo]

I'm on acala, skipping the ibrutinib treatment based on so many reports of nasty side effects. I've been on the full dose, 2 pills a day, 100mg each pill, one in the am, one in the pm with a full glass of water, no food before or after needed. I started June 26, 2019, and the side effects I've had are headaches and fatigue. No joint pain, no a fib. It dramatically decreased the size of my lymph nodes within the first week. I had a blood draw and dr appointment 1 month later, and the WBC rose to 350 and hemoglobin dropped to 8.4. Everything else was normal. The rise of WBC represented a 200 spurt, which indicates that the med is flushing out the cancer into the bloodstream. My headaches are controlled 90% of the time with Excedrin Tension Headache with Caffeine (acetominophin). The fatigue is improving, and the headaches do not occur as frequently as in the beginning. Someone has posted recently that they had joint pain after 2 months of treatment on acala. They haven't elaborated on that as to severity. From what I understand, this 2nd generation BTK inhibitor is designed to have fewer side effects than ibrutinib. That's a good thing!

[Bill1288]

I have been on Acalabrutinib since May 1st this year. Was on Imbruvica approximately 20 months before. Doing well with very little side effects. Had just a few headaches in first month, but not serious. I take 2 pills , one in am one in pm. So far so good.

Bill1288

[cartwheels]

Very good news

[shazie]

I think your doctor can write prescription and your insurance most likely would approve it. I got approved without any question. I haven’t switch from Imbruvica but my doctor wanted to test the waters.

[nozha13]

I’m on acalibrutinib for a month now. My lymph nodes have shrunk and some have disappeared. My lymphocyte count went up from 19O to 250. Neutrophils and platelets are fine. However my hemoglobin went from 97 to 78 in a month and I might have to get a transfusion. I’m not too happy about that but I hope it’s temporary. Side effects have been minimal - a few mild headaches and some minor bruising on my leg.

[DrLV in reply to nozha13]

What is the cost of the drug? What insurance do you have?

[nozha13 in reply to DrLV]

I’m in a 3 year clinical trial so no cost