Tuesday, August 5, 2014

Subcutaneous Rituxan

The United Kingdom's equivalent of the FDA has approved subcutaneous injections of Rituxan (known as MabThera over there). That means a 5 minute shot in the arm, rather than a 4 hour IV.

As someone who sat through 6 treatments of Rituxan, I think that's great news. They estimate it will save about 2.5 million Pounds Sterling (over $4 million), adding up the time and human power it takes to administer by IV. That's not a huge amount (about $2000 per patient), but it all adds up when you consider how many people get Rituxan in the U.S. -- and how much that would save for someone who self-pays.

Of course, the subcutaneous option is not available in the U.S. And as far as I can tell, there isn't a clinical trial in the U.S. that is testing it out, either -- none that I could find in my search. (This one, for example, is recruiting patients in a bunch of other countries -- Algeria, Argentina, Belgium, Brazil, Bulgaria, Canada, Colombia, Finland, France, Greece, Ireland, Israel, Italy, Netherlands, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, South Africa, Spain, Thailand, Turkey, Ukraine, United Kingdom, and Venezuela -- but not the U.S.

I'm not sure what the problem is, though I remember reading discussions about this (I think when the results for the trial that led to the UK were reported at ASH is 2012). I think there was still some fear about what would happen if a patient had a reaction; you can slow down a 4 hour infusion, but a subcutaneous injection is over in a few seconds -- no slowing it down.

But that seems like a problem that could be dealt with in trial design. Maybe the first infusion is an IV, and the rest of that course, the next 3 or 5 or 7 treatments, are injections?

I guess it's also possible that, with the patent for Rituxan expiring soon, the manufacturer just doesn't want to put more resources into it?

Whatever the case, cheers to you in the UK who might benefit from this. Bob's your uncle. (And your cancer blogger....)

4 comments:

Anonymous said...

Bob, I thank you for your blog as always.


NHS has approved? The way I understand from the article below is that Subcutaneous Injection has a step closer to approval = "Green Light".

Roche's MabThera SC to be funded on NHS
http://pharmatimes.com/Article/14-08-05/Roche_s_MabThera_SC_to_be_funded_on_NHS.aspx

NHS England has approved funding for a new sub-cutaneous formulation of Roche’s cancer drug MabThera (rituximab) which offers patients with follicular lymphoma a more convenient treatment option while potentially saving the National Health Service a lot of cash.

BR
AppleTree

Lymphomaniac said...

AppleTree,
I'm going by the statement by Roche, the company that manufactures Rituxan/MabThera: http://www.firstwordpharma.com/node/1228443#axzz39jtcoU4n. They start with the statement "Patients with one of the most common forms of blood cancer4 can now benefit from a new injection." That sounds to me like it's now available. My understanding (and I'm no expert on matters outside the U.S.) is the the European Commission approved subcutaneous MabThera in March; the NHS has now taken that EC approval and confirmed that they will pay for it.
If I'm misunderstanding all of that, please let me know.
But my bigger point is, why aren't we seeing this in the U.S?
And thanks for reading, AppleTree.
Bob

Anonymous said...

Bob,
Thank you for the detailed explanation. I now believe your understanding is right. As you may know we are suffering from "drag lag" in Japan, comparing with US and EU. For example, Rituximab maintenance for NHL has not yet approved here. (I happened to be participating stage 3 crinical trial of GA101 and am now in the midst of maintenance after CR last year).
AppleTree

Lymphomaniac said...

CR is awesome, Apple Tree. And thanks from all of us for participating in the trial. I hope that maintenance works for a good long time!
Bob