FDA News

FDA approves Rituxan Hycela subcutaneous injection for blood cancers

The FDA approved Rituxan Hycela subcutaneous injection to treat three blood cancers.

Rituxan Hycela (Genentech) — a combination of rituximab (Rituxan; Genentech, Biogen) and hyaluronidase human (Halozyme Therapeutics), is indicated for 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.

The combination may only be administered to patients who received at least one full dose of IV rituximab.

Rituxan Hycela can be administered in 5 to 7 minutes, whereas IV rituximab administration requires at least 90 minutes.

“With today’s approval of Rituxan Hycela, people with three of the most common blood cancers now have a new treatment option [that] provides efficacy comparable with intravenous Rituxan and can be delivered under the skin in minutes instead of hours through IV infusion,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a company-issued press release. “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.”

The FDA based its approval on results of four clinical trials that comprised nearly 2,000 patients. These studies included:

  • the phase 3 SABRINA trial, designed to evaluate Rituxan Hycela in combination with chemotherapy and as a maintenance therapy for previously untreated follicular lymphoma;
  • the phase 1b SAWYER study, designed to investigate the combination in previously untreated CLL;
  • the phase 3 MabEase trial, which evaluated the regimen for treatment of previously untreated DLBCL; and
  • the phase 3 PrefMab study, a patient preference study that included individuals with previously untreated follicular lymphoma and DLBCL.

These studies showed subcutaneous administration of Rituxan Hycela resulted in noninferior levels of rituximab in the blood and comparable clinical efficacy outcomes compared with IV rituximab.

In the PrefMab study, 77% of patients preferred Rituxan Hycela over IV rituximab due to the shortened amount of time required in the clinic for administration.

The most common adverse events associated with Rituxan Hycela varied by blood cancer. They included infections, low white blood cell count, nausea, constipation, cough and fatigue among patients with follicular lymphoma; infections, neutropenia, hair loss, nausea and low red blood cell count among patients with DLBCL; and infections, neutropenia, nausea, low platelet count, fever, vomiting and reddening of the skin at the injection site among patients with CLL.

The FDA approved Rituxan Hycela subcutaneous injection to treat three blood cancers.

Rituxan Hycela (Genentech) — a combination of rituximab (Rituxan; Genentech, Biogen) and hyaluronidase human (Halozyme Therapeutics), is indicated for 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.

The combination may only be administered to patients who received at least one full dose of IV rituximab.

Rituxan Hycela can be administered in 5 to 7 minutes, whereas IV rituximab administration requires at least 90 minutes.

“With today’s approval of Rituxan Hycela, people with three of the most common blood cancers now have a new treatment option [that] provides efficacy comparable with intravenous Rituxan and can be delivered under the skin in minutes instead of hours through IV infusion,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a company-issued press release. “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.”

The FDA based its approval on results of four clinical trials that comprised nearly 2,000 patients. These studies included:

  • the phase 3 SABRINA trial, designed to evaluate Rituxan Hycela in combination with chemotherapy and as a maintenance therapy for previously untreated follicular lymphoma;
  • the phase 1b SAWYER study, designed to investigate the combination in previously untreated CLL;
  • the phase 3 MabEase trial, which evaluated the regimen for treatment of previously untreated DLBCL; and
  • the phase 3 PrefMab study, a patient preference study that included individuals with previously untreated follicular lymphoma and DLBCL.

These studies showed subcutaneous administration of Rituxan Hycela resulted in noninferior levels of rituximab in the blood and comparable clinical efficacy outcomes compared with IV rituximab.

In the PrefMab study, 77% of patients preferred Rituxan Hycela over IV rituximab due to the shortened amount of time required in the clinic for administration.

The most common adverse events associated with Rituxan Hycela varied by blood cancer. They included infections, low white blood cell count, nausea, constipation, cough and fatigue among patients with follicular lymphoma; infections, neutropenia, hair loss, nausea and low red blood cell count among patients with DLBCL; and infections, neutropenia, nausea, low platelet count, fever, vomiting and reddening of the skin at the injection site among patients with CLL.