FDA Approves Cancer Drug to Treat Relapsing Multiple Sclerosis

The US Food and Drug Administration (FDA) has approved the subcutaneous injection Kesimpta (ofatumumab, formerly OMB157) to treat adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Kesimpta was first approved in 2009 as an intravenous infusion for the treatment of chronic lymphocytic leukemia. The FDA’s approval of Kesimpta for relapsing forms of MS was granted following completion of the phase 3 ASCLEPIOS I and II studies, which demonstrated that Kesimpta was superior to teriflunomide in substantially reducing the annualized relapse rate, 3-month confirmed disability progression, and the number of gadolinium-enhancing T1, as well as new or enlarging T2 lesions.

“This approval is wonderful news for patients with relapsing multiple sclerosis. In the key clinical studies, this breakthrough treatment produced a profound reduction in new brain lesions, reducing relapses, and slowing underlying disease progression,” said Stephen L. Hauser, MD, director of the University of California, San Francisco Weill Institute for Neurosciences and co-chair of the steering committee for the ASCLEPIOS I and II studies, in a press release. “Through its favorable safety profile and well-tolerated monthly injection regimen, patients can self-administer the treatment at home, avoiding visits to the infusion center.”

The most common adverse effects with Kesimpta included upper respiratory tract infection, injection-related reactions, headache, and local injection site reactions. Safety profiles between Kesimpta and teriflunomide were similar, and the frequency of malignancies and serious infections were similar in both treatment groups.

—Christina Vogt

FDA approves Novartis Kesimpta (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis. News release. Novartis. August 20, 2020.