FDA Approves Ocrevus (ocrelizumab) for Relapsing and Primary Progressive Multiple Sclerosis

Ocrevus is a CD20-directed cytolytic antibody. It binds to CD20, a cell surface antigen expressed on pre-B cells and mature B cells but not on hematopoietic stem cells or plasma cells. The antibody depletes B cells through antibody-dependent cellular cytotoxicity and complement-mediated lysis.

Ocrevus is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is also indicated for primary progressive MS in adults.

Before initiating Ocrevus, screen for hepatitis B virus, obtain serum quantitative immunoglobulins, aminotransferases, alkaline phosphatase, and bilirubin. Pre-medicate with 100 mg methylprednisolone (or equivalent) and an antihistamine (e.g., diphenhydramine) prior to each infusion. Administer by intravenous infusion: initial dose of 300 mg, followed two weeks later by a second 300 mg infusion. Subsequent doses: 600 mg every 6 months. Must be diluted in 0.9% Sodium Chloride Injection to a final concentration of approximately 1.2 mg/mL. Monitor patients closely during and for at least one hour after infusion.

Trial data not available in label.

Contraindicated in patients with active hepatitis B virus infection confirmed by positive HBsAg and anti-HBV tests. Warnings include infusion reactions, infections (including hepatitis B reactivation), and potential for increased risk of malignancies. Prior to each infusion, assess for active infection; delay if present. Live or live-attenuated vaccines are not recommended during treatment and until B-cell repletion.

Ocrevus is a first-line therapy for relapsing forms of MS and the first approved treatment for primary progressive MS. It offers a convenient every-6-month dosing schedule. Consider in patients with active disease, including those with progressive forms.