FDA Accepts BLA for Subcutaneous Formulation of Rituximab

Article

The FDA has accepted the biologics license application from Genentech for a subcutaneous formulation of rituximab for multiple blood cancer indications.

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.

Related Videos
Whole psilocybin mushroom in a clear medication capsule | Image credit: Zim - stock.adobe.com
Patient suffering from atopic dermatitis -- Image credit: Nikkikii | stock.adobe.com
Image credit: Fabio Balbi | stock.adobe.com
Image credit: Melita - stock.adobe.com
Atopic dermatitis on a patient's hand -- Image credit: Ольга Тернавская | stock.adobe.com
cropped view of man performing chest compression on dummy during cpr training class - Image credit: LIGHTFIELD STUDIOS | stock.adobe.com
Medicine law concept. Judges gavel with pills | Image Credit: Iren Moroz - stock.adobe.com
Image credit: New Africa | stock.adobe.com
© 2024 MJH Life Sciences

All rights reserved.