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The following information helps you to find FDA Alerts and Pharmacist’s Applications to Practice quickly and easily. In cooperation with the Food and Drug Administration (FDA), and as a service to our members, HOPA periodically distributes information about newly approved therapies for cancer patients from FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur to inform oncologists and professionals in oncology-related fields in a timely manner. Links to product labels will take you to relevant clinical information on the indication, contraindications, dosing, and safety. In sending this information, HOPA does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.

Along with HOPA’s Publications Committee, members also review new drug updates and provide analysis and research on the application of these new drugs or indications. Pharmacist’s Applications to Practice, or PAP, are listed after drugs that include the additional analysis. If you are interested in helping the Publications Committee with creating a Pharmacist's Application to Practice, please contact Jeff Price at jprice@hoparx.org.

You can also find additional information on FDA Alerts and Updates by listening to FDA Drug Safety Podcasts.

January 19, 2016

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s062lbl.pdf

On January 19, 2016, the U.S. Food and Drug Administration approved ofatumumab (Arzerra® Injection, Novartis Pharmaceuticals Corporation) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was previously approved for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy was considered inappropriate and also for patients with CLL refractory to fludarabine and alemtuzumab.

This new approval was based on demonstration of an improvement in progression-free survival (PFS) in a randomized, open-label trial comparing ofatumumab to observation in patients whose disease had a complete or partial response after at least two lines of prior therapy.

A total of 474 patients were randomized (1:1) to ofatumumab (n=238) or observation (n=236). The median age was 64.5 years (range 33-87). Patients in the ofatumumab arm had received a median of 2 prior therapies (range 2-5). The investigator-assessed median PFS was 29.4 months (95% CI: 26.2, 34.2) and 15.2 months (95% CI: 11.8, 18.8) in the ofatumumab and observation arms, respectively [HR: 0.50 (95% CI: 0.38, 0.66), p-value < 0.0001].

The most common adverse reactions (greater than or equal to 10%) in patients treated with ofatumumab therapy were infusion reactions, neutropenia and upper respiratory tract infection. Thirty-three percent of patients treated with ofatumumab reported serious adverse reactions. The most common serious adverse reactions were pneumonia, pyrexia and neutropenia (including febrile neutropenia).  

The recommended dose and schedule for ofatumumab therapy is 300 mg by intravenous infusion on day 1 followed by 1,000 mg on day 8 and then 7 weeks later and every 8 weeks thereafter for up to a maximum of 2 years.

This application was granted Priority Review. A description of these expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics, available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf.

Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s062lbl.pdf

 Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

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