FDA News

FDA advisory committee recommends Rituxan coformulation for blood cancers

An FDA advisory committee unanimously recommended approval of subcutaneous rituximab plus hyaluronidase for the treatment of several blood cancers.

The advisory committee determined the risk–benefit ratio was favorable for the following indications: previously untreated follicular lymphoma or diffuse large B-cell lymphoma; relapsed or refractory low-grade or follicular lymphoma; and previously untreated or relapsed/refractory chronic lymphocytic leukemia.

The coformulation includes the same monoclonal antibody as IV rituximab (Rituxan; Genentech, Biogen) and hyaluronidase, a molecule that helps deliver medicine 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 company-issued 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 committee unanimously supported this new coformulation.”

The FDA’s Oncologic Drugs Advisory Committee reviewed results of a clinical development program that included five studies with more than 2,000 patients with blood cancers.

The studies demonstrated subcutaneous administration of the coformulation resulted in noninferior levels of rituximab in the blood compared with IV rituximab.

In addition, clinical efficacy and safety outcomes of subcutaneous administration were consistent with IV administration.

The FDA — which is not obligated to follow the advisory committee’s recommendation — is expected to make a decision by June 26.

Rituximab — a monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells — already is approved as an IV formulation for untreated follicular lymphoma, previously untreated DLBCL, relapsed or refractory low-grade or follicular lymphoma, and previously untreated or relapsed/refractory CLL.

An FDA advisory committee unanimously recommended approval of subcutaneous rituximab plus hyaluronidase for the treatment of several blood cancers.

The advisory committee determined the risk–benefit ratio was favorable for the following indications: previously untreated follicular lymphoma or diffuse large B-cell lymphoma; relapsed or refractory low-grade or follicular lymphoma; and previously untreated or relapsed/refractory chronic lymphocytic leukemia.

The coformulation includes the same monoclonal antibody as IV rituximab (Rituxan; Genentech, Biogen) and hyaluronidase, a molecule that helps deliver medicine 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 company-issued 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 committee unanimously supported this new coformulation.”

The FDA’s Oncologic Drugs Advisory Committee reviewed results of a clinical development program that included five studies with more than 2,000 patients with blood cancers.

The studies demonstrated subcutaneous administration of the coformulation resulted in noninferior levels of rituximab in the blood compared with IV rituximab.

In addition, clinical efficacy and safety outcomes of subcutaneous administration were consistent with IV administration.

The FDA — which is not obligated to follow the advisory committee’s recommendation — is expected to make a decision by June 26.

Rituximab — a monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells — already is approved as an IV formulation for untreated follicular lymphoma, previously untreated DLBCL, relapsed or refractory low-grade or follicular lymphoma, and previously untreated or relapsed/refractory CLL.