McKesson Selected by TESARO to provide ZEJULA (niraparib), Approved for the Treatment of Recurrent Ovarian Cancer
The Woodlands, Texas (May 12, 2017) — McKesson Corporation 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, 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 was also selected by TESARO as one of ZEJULA’s distributors of choice for in-office dispensing practices. Additionally, Biologics by McKesson, an independent specialty pharmacy with more than 24 years of experience connecting patients to life-changing medications in oncology and other complex therapeutic areas, 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’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 http://www.zejula.com/.
About US Oncology Research
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
About Biologics by McKesson
Biologics by McKesson is an independent specialty pharmacy with over 24 years of experience connecting patients to life-changing medications in oncology and other complex therapeutic areas. Built on the foundation of deep clinical expertise and a high-touch approach to patient care, Biologics by McKesson delivers seamless access and personalized engagement, so patients get the most out of the care they receive. As part of McKesson Life Sciences, a business within McKesson Corporation, Biologics by McKesson harnesses unparalleled reach and connectivity across the healthcare system to connect the dots between payers, providers and biopharma, so together, they can deliver better care and outcomes for every patient.
McKesson Corporation, currently ranked 6th on the FORTUNE 500, is a global leader in healthcare supply chain management solutions, retail pharmacy, community oncology and specialty care, and healthcare information technology. McKesson partners with pharmaceutical manufacturers, providers, pharmacies, governments and other organizations in healthcare to help provide the right medicines, medical products and healthcare services to the right patients at the right time, safely and cost-effectively. United by our ICARE shared principles, our employees work every day to innovate and deliver opportunities that make our customers and partners more successful — all for the better health of patients. McKesson has been named the “Most Admired Company” in the healthcare wholesaler category by FORTUNE, a “Best Place to Work” by the Human Rights Campaign Foundation, and a top military-friendly company by Military Friendly. For more information, visit www.mckesson.com.