New FDA Specialty Approvals

✦ Dec. 14: The FDA approved a new dosing time for Roche Group unit Genentech USA, Inc.’s Ocrevus (ocrelizumab) to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, as well as primary progressive MS. Twice-yearly dosing via a shorter two-hour infusion is now available for people who have not experienced any serious infusion reactions. The initial dose is administered as two 300 mg two-and-a-half-hour infusions two weeks apart and then subsequent doses are 600 mg every six months. The agency initially approved the drug for subsequent infusions of three-and-a-half hours. The drug’s annual list price is $65,000, according to its website. Visit www.ocrevus.com.

✦ Dec. 16: The FDA approved MacroGenics, Inc.’s Margenza (margetuximab-cmkb) in combination with chemotherapy for the treatment of adults with metastatic human epidermal growth factor receptor 2-positive breast cancer who have received at least two anti-HER2 regimens, with at least one of them for metastatic disease. Dosing is via a 120-minute intravenous infusion at 15 mg/kg for the first dose and then over a minimum of 30 minutes every three weeks. The company says it expects the drug to be available in March. Visit www.margenza.com.

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