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The FDA approved Genentech’s CD20-targeting antibody obinutuzumab (Gazyva) for the treatment of adult patients with lupus nephritis who are receiving standard therapy.
The approval marks the fourth indication for the intravenously infused drug, joining its use in the treatment of patients with previously untreated chronic lymphocytic leukemia, in combination with chlorambucil; following bendamustine in the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab-containing regimen; and in adult patients with previously untreated stage II bulky, III, or IV follicular lymphoma who achieved at least a partial remission after receiving chemotherapy.
Obinutuzumab is just the third drug ever to be approved specifically for lupus nephritis, following belimumab (Benlysta) in 2020 and voclosporin (Lupkynis) in 2021.
The new indication is based on results from the phase 2 NOBILITY and phase 3 REGENCY studies. In the REGENCY trial, 46.4% of 135 patients in the obinutuzumab group had a complete renal response at 76 weeks compared with 33.1% of 136 patients who received a placebo plus standard therapy group. All patients in the trial received standard therapy with mycophenolate mofetil and oral prednisone, with a target prednisone dose of 7.5 mg/d by week 12 and 5 mg/d by week 24.
Obinutuzumab’s safety profile was consistent with the well-characterized profile observed in its indications for hematologic cancers, according to Genentech’s news release.
Obinutuzumab’s prescribing information says the recommended dosage for active lupus nephritis is 1000 mg at the initial infusion and at week 2, 24, 26, and every 6 months thereafter.
Genentech noted that the European Medicines Agency’s Committee for Medicinal Products for Human Use recently issued a positive opinion recommending the approval of obinutuzumab for adults with active lupus nephritis, with a final decision from the European Commission expected in the near future.
