Good news for those of you in Europe -- The EMA (European Medicines Agency, the equivalent of the FDA in the US) has approved a shorter infusion time for Obinutuzumab. Now, instead of taking 3 to 4 hours for an infusion, it should be done in about 90 minutes.
The change comes from the results of the GAZELLE study, which involves patients with Follicular Lymphoma, some who have not had a treatment yet. The purpose of the study was to find out if the Obinutuzumab infusion could be shortened, and was given as part of a treatment with chemotherapy.
Patients were given the first round as usual, with the longer time. Those patients who did not have a serious reaction were then given the shorter version for the other rounds of treatment. About 62% of the patients in the study had an infusion-related reaction, but only about 6% has a grade 3 (serious) reaction, and none had a grade 4 or 5 (most serious).
The faster infusion was based on infusion-related side effects, not side effects that came later (and 99% of patients in the study had some kind of side effect -- it's to be expected).
Obinutuzumab is given as an alternative to Rituxan. It's very similar -- a monoclonal antibody that targets the protein CD20. It is made a little bit differently, using human cells rather the mouse cells used in Rituxan. It has been approved in FL in combination with Bendamustine, followed by Obinutuzumab maintenance. It is slightly more effective that Rituxan, with slightly worse side effects.
I've never had Obinutuzumab, but I know what it's like to sit in a chair in the treatment room for 6 hours to get Rituxan. I had an allergic reaction to my first dose (which is fairly common), so the rest of my doses had to be slowed down. It would have been pretty great to have it all cut down to 90 minutes.
And, of course, that would have other benefits, too, besides the important Quality of Life changes that come with not having to spend all day in a chair. Shorter infusion times should mean a lower cost, which is good for everyone. It also could mean more safety in a more general way -- with a pandemic still going on, it would be great for someone who is immunocompromised to be able to spend less time in a hospital or doctor's office, or anywhere else with lots of people around. And less time in the chair means more space open for other patients.
The approval covers Europe, and starts immediately. No word on when the maker of Obinutuzumab plans to apply for FDA approval as well. But it's good news for a lot of you from Europe.
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