Rituxan Hycela (rituximab and hyaluronidase human) is an approved treatment for follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL). It was developed by Genentech, a member of the Roche Group.
How Rituxan Hycela works
Lymphoma and leukemia are blood cancers that tend to affect the white blood cells (or lymphocytes) that are an important part of the immune system. There are two main types of lymphocytes, T- and B-cells.
The active component is Rituxan, a monoclonal antibody, or a protein that has been designed to target and bind to a specific protein. Rituxan Hycela targets the CD20 antigen, a substance found on the surface of B-cells. By binding to CD20, it triggers the death of the B-cells to reduce the number of cancerous ones present in the body.
Hylenex allows the drug to pass through the layer of tissue under the skin (subcutaneous layer) to get to the blood vessels. It temporarily breaks down the network of hyaluronan, a substance found between cells in the subcutaneous layer, allowing the drug’s passage.
Rituxan has been approved by the U.S. Food and Drug Administration (FDA) to treat certain blood cancers since 1997. However, the drug can only be administered through an intravenous drip, a long and often inconvenient process. The addition of Hylenex to the formulation allows the drug to be administered by subcutaneous injection (injection into the tissue layer under the skin), a process that typically takes less than 10 minutes.
Rituxan Hycela in clinical trials
Rituxan Hycela was approved as a first-line and second-line treatment of follicular lymphoma, DLBCL and CLL on June 22, 2017. This combination therapy has been approved in Europe, under the brand MabThera SC, since 2014.
The approval was based on four clinical studies that included just under 2,000 participants, comparing Rituxan Hycela to Rituxan alone. All four confirmed that Rituxan Hycela was well-tolerated and safe to be used in blood cancer patients, and that there was no significant difference in the response compared to patients treated with Rituxan alone.
The Phase 1 SAWYER trial (NCT01292603) demonstrated the safety and tolerability of Rituxan Hycela in previously untreated CLL patients.
The Phase 3 SABRINA trial (NCT01200758) showed the effect of Rituxan Hycela in combination with chemotherapy to treat 410 patients with untreated FL, compared to Rituxan alone.
The Phase 3 MabEase trial (NCT01649856) assessed Rituxan Hycela compared to Rituxan alone in 576 total patients with DLBCL.
Finally, the Phase 3 PrefMab trial (NCT01724021) assessed the response of patients with FL or DLBCL, treated with either Rituxan Hycela or Rituxan alone.
Rituxan Hycela treatment is only to be initiated after the patient has completed a full course of Rituxan treatment, administered by intravenous infusion. This process can take several hours.
Rituxan Hycela can cause infections, neutropenia (a low white blood cell count), and nausea when used to treat blood cancers. When treated with Rituxan Hycela, patients with FL may experience constipation, coughing, and fatigue. DLBCL patients may experience hair loss and iron deficiency. For CLL patients, side effects include a low platelet count in the blood, fever, vomiting, and redness at the injection site.
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