Thursday, November 14, 2013

It's All Too Much: The Loss of a CLL Friend and the Approval of Ibrutinib for Mantle Cell Lymphoma

The world of CLL is unrelenting and demanding.

I tried to step away for a few days, but news, good and bad, swirled into the center of my vision, and if that didn't get my attention, it then whacked me off my seat with its wild and blunt force.

Like my six month old granddaughter saying with her fusses and her smiles, PAY ATTENTION TO ME, CLL craves to be the center of the universe.

We lost another CLL warrior today. A member of our Orange County support group, Susie Vercruse passed from complications from a stroke. This was not likely a direct CLL issue, as even with counts of a million or more lymphocytes, we don't get the dangerous hyperviscosity (the blood gets too thick) seen in other blood cancers than can lead to blood clots, but that doesn't ease the pain. I will miss her easy smile and friendly positive ways. Very sad.

And yesterday we gain a new warrior in our CLL battles. Well sorta. 

Ibrutinib or should I say now say Imbruvica was approved for relapsed and refractory mantle cell lymphoma (MCL).

This is very good news. It was as a friend in Houston said: a clean approval: No black box warnings concerning use with blood thinners (an early concern in some trials). 

The label says:

Five percent of patients with MCL had Grade 3 or higher bleeding events (subdural hematoma, gastrointestinal bleeding, and hematuria). Overall, bleeding events including bruising of any grade occurred in 48% of patients with MCL treated with 560 mg daily.
The mechanism for the bleeding events is not well understood.
Consider the benefit-risk of ibrutinib in patients requiring antiplatelet or anticoagulant therapies.
Consider the benefit-risk of withholding ibrutinib for at least 3 to 7 days pre and post-surgery depending upon the type of surgery and the risk of bleeding 


Importantly patients only have had to fail one prior drug before they can have access to Imbruvica (get used to that name). Often new and expensive treatments are held in reserve only for those who have failed all other therapies, not just one.

Also there are no restrictions as far as I can see on how it used, alone or in combination, unlike the more limited recent approval of obinutuzumab.

MCL is much rarer than CLL, less than 3,000 cases a year in the USA, and is generally a much nastier and faster moving cancer than most CLL, with until very recently, fewer good treatment options.

Both obinutuzumab and ibrutinib could benefit a ton of patient of patients "off label", which is an ethical and legal way that many cancer and other drugs are often used.

Of course, cost will be a big issue. At an estimated more than $90 a pill for Imbruvica, the annual price tag for those of us with CLL would be just a tad under $100,000 a year. It is a full third higher in MCL as they take four 140 mg tablets daily. To their great credit, I have read that Pharmacyclics will be offering some medication free to help patients while the insurance is being worked out and will offer co-pay support for others longer term.

These days, this is the typical cost of many new cancer drugs, and is actually lower than some. Some orphan drugs used to treat very rare disorders can cost $200,000 to $400,000 a year, making ibrutinib look like a bargain.

Still 99% of us will not able to pay for that, and insurance will likely balk or in the best case scenario, take a good arm wrestle to consent to lay out that kind of cash.

We need to hope from a very broad approval for Imbruvica for CLL, speedily to minimize these issue.

It is a brave new world we are entering, and there are no easy answers. Drugs are very very expensive to get to market and for every single chemical that succeeds in making it to market, scores and scores never make it to the pharmacy. 

We can't afford it and we can't afford not to do it. 

I will post more helpful interviews real soon from iwCLL 2013 (I promise), but as John Lennon said: Life is what happens to you, while you are busy making other plans.

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1 Comments:

Anonymous Anonymous said...

Just to let you know I'm here, Brian. I rarely post. Each of your blog entries are so important to your readers. Impossible to choose one
over another. An update: Kelly, my 78 year old sweetheart is in tx for a
second time. Couldn't wait
ibrutinib out, although he
tried, God bless him. Kelly
began his CLL adventure as
you did, the Myvax trial. I'm
with you. I hate this disease.
Blessings to you. Jan

November 20, 2013 at 3:58 AM  

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