Imbruvica Approved Frontline in the USA!

[bkoffman]

This changes everything. This is very good news in contrast to the bad news in the UK.

prnewswire.com/news-release...

[Peggy4]

Really glad for all our friends 'across the pond'. Bad times for us. Reading today in all our newspapers on the new 'cancer breakthrough' makes me wonder if we can't afford this excellent drug we have on offer now, how on earth are we going to afford that!! Peggy.

[thayer in reply to Peggy4]

Imbruvica approval by FDA: Article dated 3-4-16. This seems to be old news? I have been taking this drug for 1year + with great results, here in the USA.

What's new about the article?

[AussieNeil Administrator in reply to thayer]

This New news is HUGE. Prior to this FDA approval, you either needed to have had a prior (generally chemotherapy) treatment for your CLL, or have a form of CLL that would not respond well to traditional chemotherapy treatments to meet the criteria for treatment with Ibrutinib. This is the first time the FDA has approved any form of non chemo treatment of CLL for initial, i.e. 'front line' treatment of all CLL patients.

Neil

[Peggy4 in reply to thayer]

In our British newspapers yesterday it was said that they have found a 'cure for cancer' with a jab that kills cancer cells. I just wondered how (if we cannot afford some of the great drugs available now) we are going to fund that.

[bkoffman CLL CURE Hero in reply to Peggy4]

Don't believe what you read in the papers.

[Peggy4 in reply to bkoffman]

I know, I'm rapidly coming to realise that Brian. Peggy

[bkoffman CLL CURE Hero in reply to thayer]

Before this approval, Ibrut was only available for relapsed patients or 17 p deleted. Now anyone can get it.

[Hidden in reply to bkoffman]

> Before this approval, Ibrut was only available for relapsed patients or 17 p deleted.

That was not so and you as a doctor should know that. Once given any approval it could be used "off label" if any doctor prescribed it. The only issue is how to get it paid for; if you can afford to pay for it yourself no problem. Otherwise you have to talk your insurance company into paying for it. During my many hours in the Leukemia department waiting room at MD Anderson I have met serveral patients NOT in trials who managed exactly that.

[AussieNeil Administrator in reply to Hidden]

Lab_Rat,

Dr Koffman's post was concerning the FDA Approval of Ibrutinib and his reply above was in that context. FDA approval makes a world of difference with regard to both accessibility and affordability, which is why this is such big news. CLL patients desiring non chemo first line treatment no longer need to find a doctor who is willing to prescribe the drug off label and spend time fighting the insurance companies to make it affordable and can instead help more patients. I'm certain Dr Koffman is well aware of the off label process and how some patients have been able to access Ibrutinib in that way, as are many US members.

Neil

[bkoffman CLL CURE Hero in reply to Hidden]

This approval will make it much easier for patients to get ibrutinib prescribed and paid for. Doctors don't enjoy fighting with insurance companies to get drugs for their patients and we are too often not successful. Some private docs refuse to do all the paperwork demanded. This approval will obviate those concerns and is boon for many patients. It also will allow community doctors to be educated about ibrutinib as a frontline therapy beyond 17p del, another benefit as many patients don't get their CLL care at a tertiary center such as MDACC.