FDA Committee Unanimously Recommends New Subcutaneous Dose of Rituxan

An FDA advisory committee unanimously voted to recommend approval of Genentech’s new subcutaneous formulation of Rituxan for several blood cancer indications.

The FDA’s Oncologic Drug Advisory Committee quickly voted 11-to-zero that Rituxan (rituximab) SC had a favorable risk-benefit profile; there was little discussion.

The main questions focused on possible changes in safety and effectiveness when using a fixed dose on patients with different body sizes — but committee members still found the company’s data compelling.

Genentech’s BLA is pursuing approvals in follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia — all previously indicated for standard IV rituximab, which was first approved in 1997, and is also approved in rheumatoid arthritis.