FDA Approves RITUXAN HYCELA for Subcutaneous Injection in Certain Blood Cancers
- Amanda Bridges
- June 23, 2017
- News
The FDA approved RITUXAN HYCELA™ (rituximab and hyaluronidase human) for subcutaneous injection for the treatment of adults with the following blood cancers: 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 Genentech press release including Important Safety Information is linked here, and a statement posted by the FDA about the approval is linked here.
RITUXAN HYCELA is an important new option for physicians and their patients:
- Treatment can be administered in 5 to 7 minutes, compared to 1.5 hours or more for IV Rituxan.
- It includes the same antibody as IV Rituxan in combination with hyaluronidase human, an enzyme that helps deliver Rituxan under the skin. It also comes in fixed-dose vials that do not require dilution or dose calculation based on body size.
- The approval was based on results from clinical studies that together represented nearly 2,000 people.
The press release is below as well as a statement from Meghan Gutierrez, CEO, Lymphoma Research Foundation. Visit Genentech’sHematology page on gene.com for more on our approach to hematology.
“Today’s approval of subcutaneous rituximab marks an important advance in the development of new treatment options for people with lymphoma,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “Novel therapies and new methods of administration are important to ensuring that patients and their physicians, through shared decision making, are able to access the right treatments at the right time.”
