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FDA approves Arzerra combination for relapsed CLL
The FDA today approved ofatumumab for use in combination with fludarabine and cyclophosphamide to treat patients with relapsed chronic lymphocytic leukemia, according to the drug’s manufacturer.
“This is the fourth CLL indication approved in the U.S. for ofatumumab, and we are pleased to see the availability of this treatment expand to a wider number of patients,” Jan van de Winkel, PhD, CEO of Genmab, said in a press release.
The phase 3 COMPLEMENT 2 study — designed to evaluate the addition of ofatumumab (Arzerra, Genmab) to fludarabine and cyclophosphamide — included 365 patients with relapsed CLL who researchers randomly assigned 1:1 to receive six cycles of the ofatumumab combination therapy or fludarabine and cyclophosphamide alone.
PFS served as the primary endpoint. ORR, OS, patient-reported outcomes, time to response, DOR, time to progression, time to next therapy, safety assessments and quality of life served as secondary outcomes.
Median PFS was 29.9 months among patients who received the ofatumumab combination compared with 18.8 months in patients who received fludarabine and cyclophosphamide alone (HR = 0.67).
Researchers observed no new or unusual safety issues.