McKesson Specialty Health, a division of McKesson Corporation that works together with stakeholders across the healthcare delivery system to preserve and strengthen specialty care, has played a significant role in the recent approval of ZEJULATM (niraparib). Approximately ten practices affiliated with US Oncology Research, one of the largest community-based oncology research programs in the United States supported by McKesson Specialty Health, participated in the clinical trial that led to approval by the U.S. Food and Drug Administration (FDA) on March 27, 2017. ZEJULA marks the 66th FDA approval in which US Oncology Research has contributed.
ZEJULA is a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. The American Cancer Society estimates that more than 22,000 women will be diagnosed with ovarian cancer in 2017. Historically, there have been few treatment options for women with advanced ovarian cancer.
Clinical trial results demonstrated that treatment with ZEJULA reduced the risk of disease progression or death by 74% in patients with germline BRCA mutations (HR 0.26) and by 55% in patients without germline BRCA mutations (HR 0.45).
“The FDA approval for ZEJULA differs from the approval of the other 2 PARP inhibitors in that it is indicated in “all comers”. A unique molecular signature is not required for use,” said Bradley J. Monk, MD, FACS, FACOG, who was part of the development process as the clinical trial study was designed, enrolled, analyzed and published. “Although biomarkers are important in predicting clinical activity, the efficacy of ZEJULA is so broad that a companion diagnostic is not mandatory. However, germline BRCA testing is still important in identifying families at risk for hereditary breast and ovarian cancer.” Dr. Monk is an oncologist with Arizona Oncology, an affiliate of The US Oncology Network and US Oncology Research.
McKesson Specialty Health was also selected by TESARO as one of ZEJULA’s distributors of choice for in-office dispensing practices. Additionally, Biologics, Inc., a McKesson Specialty Health oncology pharmacy services company, was selected to be a specialty pharmacy provider in the ZEJULA distribution network. Eligible Onmark and Unity GPO members also have access to contract pricing.
In-office dispensing practices looking to access ZEJULA can place orders via McKesson Specialty Health’s Customer Center or by contacting their Customer Care team at 800.482.6700. Physicians may submit prescriptions to Biologics via phone (800.850.4306), fax (800.823.4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.
ZEJULA Important Safety Information
ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including some fatal cases, was reported in patients treated with ZEJULA. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia), as well as cardiovascular effects (hypertension and hypertensive crisis) have been reported in patients treated with ZEJULA. Monitor complete blood counts to detect hematologic adverse reactions, as well as to detect cardiovascular disorders, during treatment. ZEJULA can cause fetal harm and females of reproductive potential should use effective contraception. Please see full prescribing information, including additional important safety information, available at www.zejula.com.
About McKesson Specialty Health
McKesson Specialty Health, a division of McKesson Corporation, works together with stakeholders across the healthcare delivery system to preserve and strengthen specialty care, passionately driven by the benefits it provides patients and the system as a whole. Through innovative provider, practice management, manufacturer and payer solutions, McKesson Specialty Health focuses on improving the financial, operational and business health of our customers and partners so they may provide the best care to patients. At McKesson Specialty Health, we believe that we are all in this together. For more information, visit www.mckessonspecialtyhealth.com.
About US Oncology Research
Supported by McKesson Specialty Health and The US Oncology Network, US Oncology Research draws from a network of experienced investigators and dedicated clinical staff who specialize in oncology clinical trials. US Oncology Research serves 60 research sites and approximately 170 locations managing about 300 active trials at any given time. Physicians in the research network have enrolled more than 66,000 patients in over 1,500 trials since inception in 1992 and have played a role in nearly 70 FDA-approved cancer therapies, approximately one-third cancer therapies approved by the FDA to date. For more information visit https://www.usoncology.com/oncologists/us-oncology-research. To find clinical trials available through US Oncology Research visit http://trialfinder.usoncology.com
Biologics, Inc. is an oncology pharmacy services company that empowers healthcare providers, payers and biopharma to optimize cancer care for the best possible outcomes – clinical, financial and emotional. Unifying fragmented healthcare services, Biologics brings efficiency and humanity to oncology care management by focusing on the patient’s best interest as the surest path to managing cost and risk. Biologics is part of McKesson Specialty Health, a division of McKesson Corporation empowering the community patient care delivery system by helping community practices advance the science, technology and quality of care. Through innovative clinical research, business and operational solutions, facilitated by integrated technology systems, we focus on improving the financial health of our customers so they may provide the best care to their patients. Our combined organization will help better support patients and expedite access to oncology therapies. For more information, visit www.mckessonspecialtyhealth.com and www.biologicsinc.com.