FDA says yes to rapid-acting Rituxan
- The Food and Drug Administration has said yes to Genentech's Rituxan Hycela (rituximab and hyaluronidase human) for under the skin administration in three blood cancers, a little ahead of its PDUFA date of June 26. The rapid-acting reformulation will cut time for dosing from an hour and a half or more to five to seven minutes.
- The approval covers previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma (DLBCL), and previously untreated and previously treated chronic lymphocytic leukemia (CLL). The new formulation isn't indicated for use in non-malignant conditions.
- Clinical studies showed non-inferior levels of rituximab in the blood and comparable levels of efficacy when comparing Rituxan Hycela and intravenous Rituxan. Side effects were similar, except for local skin reactions, which were higher for Rituxan Hycela.
“With today’s approval of Rituxan Hycela, people with three of the most common blood cancers now have a new treatment option which provides efficacy comparable with intravenous Rituxan and can be delivered under the skin in minutes instead of hours through IV infusion,” said Sandra Horning, chief medical officer and head of Global Product Development. “People who benefit from Rituxan may receive years of repeated treatments for their blood cancer, so an option that reduces the administration time can be important.”
Rituxan is facing global biosimilar competition, and while Roche claims to be confident in its ability to defend itself, it is very much dependent on sales of its top three cancer drugs, which includes Rituxan (called MabThera in Europe). Just this week, Sandoz snagged approval for Rixathon, a Rituxan copycat, in Europe. While biosimilar competition hasn't yet hit the U.S., Sandoz has plans to submit Rixathon in the U.S. later this year.
So the launch of Rituxan Hycela, expected in the next few weeks, could give the company a sales boost in its U.S. oncology franchise, as well as making life easier for patients and physicians. It has already been shown as a driver in markets outside the U.S. In the first quarter 2017, Roche's oncology sales grew by 4% year on year.
"The entire [oncology] franchise grew 4%... MabThera and Rituxan in oncology grew at 3%. That growth was essentially driven by increased demand in the U.S., EU and international… MabThera subcutaneous sales contributed around half the sales growth. The subcutaneous formulation was launched in the first quarter in additional 18 countries in quarter one, bringing the total to 41 countries," said Daniel O'Day, CEO of Roche Pharmaceuticals during first quarter earnings.
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