FDA approves Arzerra in combination with chlorambucil for patients with CLL for whom fludarabine-based therapy is considered inappropriate

April 21, 2014

FDA has approved a new indication for ofatumumab (Arzerra, GlaxoSmithKline and Genmab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

FDA has approved a new indication for ofatumumab (Arzerra, GlaxoSmithKline and Genmab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

“With this new approval, Arzerra’s indications have been broadened which means that more patients may benefit from its use,” according to Bernadette King, director, US Oncology Communications, GlaxoSmithKline.

Arzerra is also indicated as a monotherapy for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.

CLL, the most commonly diagnosed adult leukemia in Western countries, accounts for approximately one-third of all cases of leukemia,” said King. “Treatment of CLL is complex and depends on a number of factors, including the extent of the disease, whether the disease has been previously treated, the patient’s age, symptoms, and the general health of the patient. The approval of additional first-line CLL treatment options are likely to be welcomed by patients, caregivers, and healthcare professionals; as such, would be of interest to formulary managers.” 

The approval of this new indication is based on results from a randomized, open-label, parallel-arm pivotal phase 3 study (COMPLEMENT 1) which demonstrated statistically significant improvement in median progression-free survival (PFS) in patients who received the combination of ofatumumab and chlorambucil compared to patients who received chlorambucil alone.

The results from COMPLEMENT 1 study, evaluating the combination of ofatumumab and chlorambucil (N=221) versus chlorambucil alone (N=226) demonstrated statistically significant improvement in median PFS in patients randomly assigned to ofatumumab and chlorambucil compared to patients randomly assigned to chlorambucil alone (22.4 months vs 13.1 months, respectively) (HR=0.57 [95% CI, 0.45, 0.72] P<.001).