Novartis files leukemia drug Arzerra in the EU
- Arzerra (ofatumumab) was co-developed by Genmab and Novartis for treatment of relapsed chronic lymphocytic leukemia (CLL).
- Arzerra is already approved in Europe for use as part of combination therapy based on various indications.
- The application is based on interim data from a phase 3 trial.
According to Novartis, adding Arzerra to standard CLL chemotherapy (fludarabine and cyclophosphamide) increased overall progression-free survival by 54% in a phase 3 trial—the PROLONG study—the included a total of 365 patients with relapsed CLL. Specifically, PFS was 28.9 months in the Arzerra group, compared with 18.8 months in the standard chemotherapy group (P=0.0032).
In addition, patients who received Arzerra plus standard chemotherapy had a higher overall response rate, compared with patients treated with standard chemotherapy (84% vs. 68%, P=0.0003). To this point, Arzerra has been used as first-line treatment for CLL, not only in the U.S., but also in Russia, Iceland, Norway, Luxembourg and Brazil.
Based on the demonstration of efficacy in relapsed CLL, expansion of the label would make perfect sense given the exsiting knowledge of Arzerra's safety and tolerabilty profile, as well as the tremendous long-standing need associated with relapsed CLL.