The Food and Drug Administration (FDA) has approved the supplementary Biologics License Application (sBLA) for a shorter infusion time of 2 hours for Ocrevus® (ocrelizumab; Genentech) for patients with relapsed or primarily progressive multiple sclerosis (MS).
The approval was based on data from the randomized, double-blind phase 3b ENSEMBLE PLUS study, which compared the frequency and severity of infusion-related reactions for a 2-hour Ocrevus infusion time with the previously approved 3.5-hour infusion time in relapse-emitting patients MS. Patients received the approved initial dosing schedule of two intravenous (IV) infusions of 300 mg separated by 2 weeks, followed by subsequent doses of intravenous infusions of 600 mg over a shorter period of 2 hours every 6 months.
The primary endpoint was the proportion of patients with infusion-related reactions after the first randomized 600 mg infusion; The frequency and severity were assessed during and for 24 hours after the infusion.
The results showed that the incidence of infusion-related reactions was comparable between infusion times of 2 hours (24.6%) and 3.5 hours (23.1%). The majority of reactions were mild or moderate and more than 98% resolved without complications in both treatment arms. There were no interruptions due to infusion-related reactions and no new safety signals were identified.
Ocrevus, a CD20-directed cytolytic antibody, has been associated with infusion reactions such as pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnoea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache. Dizziness, nausea, tachycardia, and anaphylaxis. An incidence of infusion reactions in treated patients of 34-40% has been observed in several studies, with the highest incidence associated with the first infusion. To reduce the frequency and severity of infusion reactions, it is recommended that patients be treated previously with methylprednisolone and an antihistamine. An antipyretic can also be considered.
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1. The FDA approves Genentech Ocrevus (ocrelizumab) shorter 2-hour infusion for relapsed and primary progressive multiple sclerosis. [press release]. South San Francisco, Calif .: Genentech; December 14, 2020.
2. Ocrevus [package insert]. South San Francisco, Calif .: Genentech; 2020.
This article originally appeared on MPR