An FDA committee has recommended that subcutaneous Rituxan be approved.
Subcutaneous -- "under the skin" -- Rituxan is given by an injection rather than through an IV. A shot in the arm (though I guess it could be a shot somewhere else).
The subcutaneous Rituxan should take about 5-7 minutes to administer, rather than the 90 minutes it takes for IV Rituxan. (And that 90 minutes assumes that everything is going well. When I had it, I had an allergic reaction, so the first infusion took about 4 or 5 hours.)
The recommendation comes because of results from 5 clinical trials that used subcutaneous Rituxan, and found that the results were very similar to IV Rituxan. For example, in the phase III SABRINA trial, patients were given R + Chemo, with some patients getting Rituxan through an IV and some getting the Rituxan in subcutaneous form.The results were almost identical -- an Overall Response of 89.9% for the IV and 89.4% for subcutaneous, with Complete Response rates of 32.2% for both.
About 50 countries already use subcutaneous Rituxan (so if you didn't get the "shot in the arm" joke, all of this is probably old news to you.) It saves time, saves money, and generally makes a bad thing just a little less bad.
One question I have about all of this: does a subcutaneous administration re-start the clock on the manufacturer's proprietary ownership of Rituxan? In other words, other companies are allowed to make biosimilars of Rituxan now, which will mean fewer people will use actual Rituxan. Can those companies immediately start making or using biosimilar subcutaneous Rituxan, too? Or is this a new treatment altogether, and they'll have to wait a while, giving subcutaneous Rituxan no competition? If anyone has an answer, I'd appreciate it.
The FDA will make a final decision on approving subcutaneous Rituxan by June 26. I hope none of us need it any time soon, but it will be nice to know that it's there if we do.
The
phase III SABRINA trial compared the rituximab formulations in
combination with CHOP or CVP chemotherapy in previously untreated
patients with FL. The ORR was 84.9% in the IV arm (205 patients) and
84.4% in the SC arm (205 patients; P = 0.8911). The CR rates were 32.2%
versus 32.2%, respectively. The HR for PFS was 0.84 (95% CI, 0.57-1.23; P
= 0.3696) and the HR for OS was 0.81 (95% CI, 0.42-1.57; P = 0.5398). -
See more at:
http://www.onclive.com/web-exclusives/fda-panel-supports-subcutaneous-rituximab-for-blood-cancers#sthash.eNwNMEeQ.dpuf
4 comments:
Hi Bob, I had sub cut half way through my ritux only treatment, it is administered by a tummy injection, I often joked with the nurses that I removed my six pack for a 24 pack so they had a fatter tummy to inject. It is a fantastic advance in and out in 15 minutes pretty painless sits under the skin like a gel for a day or so, I could make a smiley face by drawing with my finger on the injection site that would last for 15 mins or so lol, a bit strange you may think but I always try to bring humour to my diagnosis, especially in front of my very much loved family, i think when I smile and laugh they smile and laugh inside that Dad/ Husband/son is coping, privately it's hard but I won't let it be hard on them through me. Hope this makes sense 😉
Popplepot, that smiley face drawing is disgusting and hilarious, and I wish I had been able to do it for my kids. That's great. You know how important I think humor is when dealing with all of this.
Thanks for the information. It's very helpful.
Bob
Very cool. My understanding was that they have been using the shot in Europe for awhile now.
Thanks for this! I due to be finished with my 6 R-CVP cycles in June & will the start the Ritux maintenance afterwards every 2 months for 2 years after that to my doc. Maybe I'll get lucky & my HMO will have this by then!
Liz
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