FDA Accepts BLA for Subcutaneous Formulation of Rituximab

The FDA has accepted the biologics license application from Genentech for a subcutaneous formulation of rituximab for multiple blood cancer indications. The co-formulation, created with Halozyme’s proprietary recombinant human hyaluronidase enzyme, has been approved and marketed as MabThera SC outside the United States.

Rituximab is a cancer medication that can be used in combination with methotrexate to treat symptoms of adult rheumatoid arthritis. The most common side effects of the drug are headache, fever, chills, stomach pain, nausea, and diarrhea.

"We are excited to see Genentech and Roche taking steps to bring a subcutaneous formulation of rituximab to patients in the United States," said Dr. Helen Torley, president and chief executive officer of Halozyme, in a press release. "If approved, this formulation has the potential to reduce administration time for patients and health care practitioners."

The European Commission originally approved MabThera SC for people with untreated and relapsed/refractory chronic lymphocytic leukemia in May 2016 in a 1600-mg dose.

“MabThera SC provides patients with significantly faster treatment administration and the opportunity to enjoy more time outside the clinical setting compared to intravenous delivery of the medicine,” said Sandra Horning, MD, chief medical officer and head of Global Product Development for Roche/Genentech, in a press release.

The approval was based on data from the phase 1b SAWYER study, which exhibited the safety and efficacy of MabThera in patients.