On the 10th November 2016, the EMA CHMP gave a positive opinion for a change to the terms of marketing authorization for Arzerra®, ofatumumab, which was submitted by Novartis Europharm Ltd1. The new positive opinion extends the use of ofatumumab to adult patients with relapsed CLL, when used in combination with fludarabine and cyclophosphamide.
The new opinion is based on the open-label, randomized, Phase III COMPLEMENT 2 study2 which evaluated the efficacy of using ofatumumab in combination with both fludarabine and cyclophosphamide, compared with the combination without ofatumumab. The COMPLEMENT 2 study presented data that the median PFS of the group who received ofatumumab in addition to fludarabine and cyclophosphamide was 28.9 months, compared with 18.8 months in the group who did not receive ofatumumab (HR =0.67, p=0.0032).
The full positive opinion for Arzerra® (ofatumumab) now reads:
"Previously untreated chronic lymphocytic leukaemia (CLL):
Arzerra® in combination with chlorambucil or bendamustine is indicated for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy.
Arzerra® is indicated in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed CLL.
Arzerra® is indicated for the treatment of CLL in patients who are refractory to fludarabine and alemtuzumab."
- European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP) Opinion, Arzerra, 10th November 2016. EMA/CHMP/693024/2016
- Robak, T. et al. Ofatumumab plus fludarabine and cyclophosphamide in relapsed chronic lymphocytic leukemia: results from the COMPLEMENT 2 trial. Leuk Lymphoma. Oct 2016. 12:1-10. DOI: 10.1080/10428194.2016.1233536