The FDA announced on Friday that it has approved Obinutuzumab (also known as Gazyva) as a treatment for Follicular Lymphoma. This is good news.
Obinutuzumab is a humanized monoclonal antibody that targets CD20. So it's a lot like Rituxan, which also targets CD20. The big difference is that Obinutuzumab is humanized -- made from human cells, not mouse cells, like Rituxan. There is some feeling that this will make it safer than Rituxan and will cause fewer allergic reactions.
The specific treatment that was approved involves Obinutuzumab + Bendamustine, followed by Obinutuzumab on its own. It is meant for patients who took Rituxan + chemotherapy, but who have had the disease return within 6 months.
The approval was based on the GADOLIN study, which involved 321 FL patients (along woth some other NHLs), which compared the Obinutuzumab + Bendamustine + Obinutuzumab, to Bendamustine on its own. Patients who were given only Bendamustine had a median Progression Free Survival (the time it took for the FL to come back) of 13.8 months. The Obinutuzumab patients had a median PFS of 29.2 months -- more than a year, and more than double the Bendamustine results.
Those are good results.
It will be interesting to see if Obinutuzumab gets a lot of off-label use as a single-agent treatment, given that it is similar to Rituxan. But it's more likely that it will be used in combination treatments, the way Rituxan is used so often. there are already a bunch of trials for Obinutuzumab combinations.
So we have another arrow in the quiver. Cause for celebration.