An injected formulation of rituximab and hyaluronidase for treating certain blood cancers is one step away from U.S. approval.
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee has recommended the therapy for previously untreated follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), and relapsed or refractory low-grade follicular lymphoma. The FDA is expected to make a final decision on the formulation, which can be administered much quicker than the intravenous formulation, by June 26.
An intravenous version of rituximab and hyaluronidase has already won FDA approval. The injected formulation includes the same antibody as Rituxan (rituximab) plus hyaluronidase, a molecule that helps deliver medicines under the skin.
“Subcutaneous rituximab can be administered in five to seven minutes, compared to an hour and a half or more for intravenous Rituxan,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a press release. “The significant reduction in administration time could especially benefit people with blood cancer who may receive years of treatment, and we are pleased the [FDA] committee unanimously supported this new co-formulation.”
Currently, Rituxan is approved in the United States as an intravenous formulation for patients with previously untreated follicular lymphoma, previously untreated DLBCL, relapsed or refractory low-grade or follicular lymphoma, and previously untreated and relapsed or refractory chrolic lymphocytic leukemia (CLL).
The FDA committee’s recommendation was based on five clinical studies assessing subcutaneous rituximab’s ability to treat more than 2,000 patients for the same conditions that Rituxan was approved for.
The SparkThera Phase 1b trial (NCT00930514) assessed subcutaneous rituximab as a maintenance therapy in patients with previously untreated or relapsed follicular lymphoma.
The SABRINA Phase 3 study (NCT01200758) compared the effectiveness of Rituxan and subcutaneous rituximab as an induction and maintenance therapy in previously untreated follicular lymphoma patients.
The MabEase Phase 3 trial (NCT01649856) evaluated the effectiveness of Rituxan versus rituximab, both in combination with chemotherapy, in patients with CD20-positive DLBCL.
The PrefMab Phase 3 study (NCT01724021) evaluated patients’ preference for subcutaneous administration of rituximab versus intravenous injection. The participants included people with CD20-positive follicular lymphoma and DLBCL patients who had yet to receive therapy.
The SAWYER Phase 1b study (NCT01292603) examined subcutaneous versus intravenous rituximab in previously untreated CLL patients.
The studies revealed that subcutaneous rituximab works as well as intravenous Rituxan, generating similar rituximab levels in the blood. It also safe, the studies showed.
The injected formulation has been approved in the European Union since 2014 and in 50 other countries. If the FDA approves it, intravenous Rituxan will continue to be available to American patients.
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