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