SOUTHBOROUGH, Mass.--(BUSINESS WIRE)--Veristat, a full service Clinical Research Organization (CRO), congratulates TESARO, Inc. on the approval of ZEJULA™. TESARO’s novel oncology therapy niraparib (trade name, ZEJULA™) was approved on March 27, 2017 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 (CR or PR) to platinum-based chemotherapy. Niraparib is an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor that demonstrated a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status, in a randomized, prospectively designed Phase 3 clinical trial. Veristat worked closely with the TESARO clinical team and would like to congratulate TESARO on this great accomplishment.
Veristat worked with TESARO over the past 4 years to provide biostatistical, data standards, SAS programming and medical writing support for the New Drug Application (NDA) submission for niraparib.
“We were fortunate to have been brought in by TESARO at a critical point in the pre-analysis phase of their pivotal study, to assist with the development of the statistical methodology, including the appropriate hierarchical strategy to accommodate biomarker information in the key endpoint analyses. The Veristat team then provided the data analysis and medical writing for the pivotal study and the NDA summary documents, in a true collaboration with the TESARO clinical team.” said John Balser, PhD, President and Chief Biostatistician at Veristat.
“The Veristat team is honored to have worked with TESARO on this impactful treatment option for women with ovarian cancer,” stated Patrick Flanagan, Chief Executive Officer at Veristat. “We are hopeful to continue our collaboration with TESARO in the development of niraparib as a therapy for additional oncology indications.”
Ovarian cancer is the fifth-most frequent cancer causing death to women, where approximately 22,000 cases are diagnosed in the United States each year and more than 65,000 are diagnosed in Europe. FDA approval of niraparib was based upon data from an international, double-blind, placebo-controlled Phase 3 trial that enrolled 553 patients with recurrent ovarian cancer who had achieved either a PR or CR to their most recent platinum-based chemotherapy.
“We thank Veristat for their collaborative efforts and support of our NDA submission,” said Mary Lynne Hedley, Ph.D., President and Chief Operating Officer of TESARO, “The Veristat team accepted and achieved our rapid timelines so that we could meet our ultimate goal of bringing this meaningful new medicine to patients and their families as quickly as possible.”
Veristat is a consultative clinical research organization (CRO) that is committed to partnering with pharmaceutical, biotechnology and medical device firms to advance their therapies through the clinical development and regulatory submission process. Veristat helps clients solve the unique and complex challenges that arise when trying to accelerate therapies along the development pathway. Veristat provides experience-based strategic decision-making, the operational efficiencies to manage and monitor international trials, the biometrics expertise to collect, analyze & report clinical trial data to various regulatory agencies, and the therapeutic and medical proficiency to mastermind the entire process. Ultimately, we guide our clients to market success so that their therapies become available to improve and save people’s lives. For more information, visit www.veristat.com.
*ZEJULA™ is a trademark of TESARO, Inc.