The U.S. Food and Drug Administration has granted priority review designation to Arzerra (ofatumumab) as maintenance therapy for patients with relapsed chronic lymphocytic leukemia (CLL). Arzerra is a human monoclonal antibody designed to target the CD20 molecule found on the surface of CLL cells and normal B lymphocytes.
Arzerra, which is marketed under a collaboration agreement between Genmab and Novartis, has previously been approved in combination with chlorambucil for the treatment of patients with previously untreated CLL for whom fludarabine-based therapy is considered inappropriate (OT 5/10/14 issue).
The approval will be based on data from the Phase III PROLONG (OMB112517) study, which evaluated the response to maintenance therapy with Arzerra compared with no further treatment in patients with relapsed CLL who had a partial or complete response to second- or third-line treatment. Interim results from this study were presented at last year's American Society of Hematology Annual Meeting.
The Priority Review designation shortens the time to complete a drug's review and aims to deliver a decision on marketing approval designation for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists within six months under the Prescription Drug User Fee Act (PDUFA). The FDA action date for Arzerra for this indication is January 21.
Also receiving the designation is Kyprolis (carfilzomib) for the treatment of patients with relapsed multiple myeloma. The FDA action date for Kyprolis for this indication is January 22.
Kyprolis, marketed by Onyx Pharmaceuticals, was approved earlier this year for use in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. The drug was also previously approved for the treatment of patients with multiple myeloma who have received at least two prior therapies, including treatment with bortezomib and an immunomodulatory therapy (OT 8/25/12 issue).
Approval for the new indication will be based on data from the Phase III head-to-head ENDEAVOR study (which were presented at the American Society of Clinical Oncology Annual Meeting earlier this year) that showed progression-free survival was nearly twice as long (18.7 months) for patients with relapsed multiple myeloma who were treated with Kyprolis and low-dose dexamethasone compared with patients treated with bortezomib and low-dose dexamethasone (9.4 months) (OT 7/25/15 issue).