FDA Approves Subcutaneous Version of Rituximab For Several Rare Blood Cancers

James Radke

The U.S. Food and Drug Administration (FDA) has approved Rituxan Hycela (rituximab and hyaluronidase human) for the treatment of adults with the following rare blood cancers:

The treatment will be administered subcutaneously as the addition of hyaluronidase helps deliver rituximab under the skin. The new route of administration can allow patients to be treated within minutes rather than the hours currently needed to administer rituximab intravenously.
Per a release by makers of the drug, Genentech, Sandra Horning, M.D., chief medical officer and head of Global Product Development at Genentech said, “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.”
The FDA approval is based on non-inferiority clinical studies showing the subcutaneous administration of Rituxan Hycela was not different than intravenous administration of Rituxan with regard to efficacy and pharmacokinetics. Furthermore, one study showed that 77% of patients stated they prefer the shorter subcutaneous route over the intravenous one. In total, over 2,000 patients have been tested with Rituxan Hycela.
With the exception of local skin reactions, the incidence and profile of adverse reactions for Rituxan Hycela were comparable with those for intravenous Rituxan. Common adverse events in people with follicular lymphoma were infections, low white blood cell count (neutropenia), nausea, constipation, cough and fatigue. The most common adverse reactions in people with DLBCL were infections, neutropenia, hair loss (alopecia), nausea and low red blood cell count (anemia). The most common adverse reactions in people with CLL were infections, neutropenia, nausea, low platelet count (thrombocytopenia), fever (pyrexia), vomiting and reddening of the skin (erythema) at the injection site.
According to Genentech, Rituxan Hycela will be available within the next two weeks, and Rituxan will continue to be available.
About Follicular Lymphoma
Follicular lymphoma is a slow-growing form of non-Hodgkin’s lymphoma (NHL). It is considered incurable and relapse is common. In the United States, approximately 14,000 new cases of follicular lymphoma will be diagnosed in 2017.
About Diffuse Large B-Cell Lymphoma (DLBCL)
DLBCL is another form of (NHL) accounting for about 1 in 3 cases of NHL. DLBCL is an aggressive type of NHL with about 40% of patients relapsing. In the United States, about 24,000 new cases of DLBCL will be diagnosed in 2017.
About Chronic Lymphocytic Leukemia (CLL)
CLL is a slow growing blood cancer of the white blood cells (lymphocytes with a prevalence of about 115,500 patients in the United States and 20,000 new cases predicted for 2017.
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