FDA Approves Ofatumumab for Recurrent or Progressive Chronic Leukemia

Share this content:
The FDA has approved ofatumumab (Arzerra) for extended treatment of recurrent or progressive chronic lymphocytic leukemia.
The FDA has approved ofatumumab (Arzerra) for extended treatment of recurrent or progressive chronic lymphocytic leukemia.

The U.S. Food and Drug Administration (FDA) has approved ofatumumab (Arzerra) for extended treatment of patients who are in complete or partial response after at least 2 lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL).1

This indication is based on findings from an open-label trial that compared ofatumumab with observation in 474 patients who achieved a complete or partial response after at least 2 lines of prior therapy.

Results of that study showed that investigator-assessed median progression-free survival was 29.4 months (95% CI, 26.2 - 34.2) with ofatumumab vs 15.2 months (95% CI, 11.8 - 18.8) with observation (HR, 0.50; 95% CI,  0.38 - 0.66; P < .0001).

The most common adverse events in patients treated with immunotherapy were infusion reactions, neutropenia, and upper respiratory tract infection. A total of 33% of patients treated with ofatumumab experienced serious adverse events, the most frequent of which were pneumonia, pyrexia, and neutropenia, including febrile neutropenia.

RELATED: Patients With CLL Who Discontinue Alternate Kinase Inhibitor Treatment May Respond to Other Therapies

The recommended dose and schedule of ofatumumab therapy is 300 mg administered intravenously on day 1, followed by 1000 mg given on day 8 and a dose 7 weeks later, and then every 8 weeks thereafter for a maximum of 2 years of therapy.

Ofatumumab is already approved for the treatment of previously untreated patients with CLL who are not eligible to receive fludarabine-based therapy and for patients with CLL refractory to fludarabine and alemtuzumab.

Reference

  1. Ofatumumab (Arzerra Injection). U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm482308.htm. Published January 19, 2016. Accessed January 19, 2016.

Related Resources

You must be a registered member of Cancer Therapy Advisor to post a comment.

Regimen and Drug Listings

GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION

Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Prostate Cancer Regimens Drugs
Rare Cancers Regimens
Renal Cell Carcinoma Regimens Drugs
Skin Cancer Regimens Drugs
Urologic Cancers Regimens Drugs

Sign Up for Free e-newsletters