FDA Approves Rituxan Hycela to Treat Three Blood Cancers
The Food and Drug Administration (FDA) has approved Rituxan Hycela (rituximab and hyaluronidase human) for subcutaneous injection for the treatment of follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. The product combines the CD20-directed cytolytic antibody rituximab with hyaluronidase human, an endoglycosidase that increases the permeability of the subcutaneous tissue allowing for increased absorption of rituximab.
In the treatment of follicular lymphoma (FL), Rituxan Hycela is indicated for relapsed or refractory FL as a single agent; for previously untreated FL in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy; and for non-progressing (including stable disease) FL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.
Rituxan Hycela is also indicated for previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone or other anthracycline-based chemotherapy regimens and for previously untreated and previously treated chronic lymphocytic leukemia in combination with fludarabine and cyclophosphamide.
The approval of Rituxan Hycela was based on results from clinical studies which showed comparable clinical efficacy and pharmacokinetics between the subcutaneous product and intravenous (IV) Rituxan. Subcutaneous administration of Rituxan Hycela was also preferred over Rituxan IV by a majority of patients (77%) in one of the studies as the SC route shortens the administration time to 5–7 minutes compared to an IV infusion that can take 1.5 hours or more. With the exception of cutaneous reactions, the incidence and profile of adverse reactions for Rituxan Hycela were comparable with those for Rituxan IV.
“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, MD, 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 Hycela will be available within 1–2 weeks as individually packaged single-dose vials in 1400mg (rituximab)/23400 Units (hyaluronidase human) and 1600mg (rituximab)/26800 Units (hyaluronidase human). Rituxan Hycela treatment should be initiated only after patients have received at least one full dose of a rituximab product by intravenous infusion.
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