Arizona Oncology Plays Pivotal Role in Securing FDA Approval of Zejula (Niraparib) for Treatment in Advanced Ovarian Cancer
Arizona Oncology physician, Bradley Monk, MD, is among the lead research investigators on this breakthrough therapy.
Phoenix, AZ, May 04, 2020 – Arizona Oncology, a premier provider of advanced cancer care throughout Arizona and a practice in The US Oncology Network, is excited to announce the FDA approval of Zejula® (niraparib) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.1 Practice doctor, Bradley J. Monk, MD, was a lead US research investigator on the study that led to this breakthrough therapy.
“This is an important step forward in the treatment of ovarian cancer. In my opinion, this new maintenance approval in newly diagnosed patients should be considered in all suitable patients and will undoubtedly impact more women now that it is available earlier,” said Dr. Monk, gynecologic oncologist with Arizona Oncology and medical director of The US Oncology Network Gynecologic Research Program.
According to the American Cancer Society, ovarian cancer is the leading cause of death of all gynecological cancers. In an effort to find new and effective treatment options, researchers began studying niraparib in cases of advanced ovarian cancer. Niraparib was granted fast track designation by the FDA, and Tesaro submitted a new drug application in 2016. It was approved in recurrent ovarian cancer in March 2017 in the U.S. The effectiveness of niraparib was investigated in PRIMA, a double-blind, phase III placebo-controlled trial. Based on the PRIMA data, niraparib gained FDA approval on April 29th, 2020. Results from the study were published in The New England Journal of Medicine article “Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer.”
The PRIMA trial enrolled 733 women with newly diagnosed, advanced ovarian cancer who were at exceptionally high risk of recurrence. Patients were randomized 2:1 to niraparib versus active surveillance. The data from the PRIMA study showed that niraparib led to a statistically significant improvement in progression-free survival (PFS) compared with placebo in the overall population.2
“Our investigators at The US Oncology Network played key and pivotal roles in this trial, including accrual, scientific guidance, strategy and regulatory support for this first-in-disease setting decision by the FDA. We are very proud of this accomplishment and what it means for patients,” said Robert Coleman, MD, chief scientific officer, The US Oncology Network.
Arizona Oncology is excited to have contributed such a crucial piece in this groundbreaking research and approval. Its multidisciplinary team of experts is dedicated to advancing cancer treatment options for patients throughout Arizona and the nation.
To schedule an appointment with the Arizona Oncology cancer care team or for more information on this exciting new treatment, contact the practice at 888-972-CURE (2873).
About Arizona Oncology
Arizona Oncology is one of the largest medical groups in Arizona. With more than 120 practicing clinicians devoted exclusively to providing comprehensive, compassionate and high-quality cancer care, Arizona Oncology specializes in medical, gynecologic, and radiation oncology, as well as hematology, stem cell transplant, breast surgical oncology, urology, colorectal, research, cancer genetic risk assessment, and patient ancillary programs. The physicians and their staff treat patients in many communities throughout the state including Deer Valley, East Valley (Tempe)Flagstaff, Glendale, Goodyear, Green Valley, Phoenix, Prescott, Prescott Valley, Scottsdale, and Tucson.
Arizona Oncology believes it is beneficial to provide cancer therapies in a community setting, close to patients’ homes and support systems. The physicians are supported by a talented clinical team sensitive to the needs of cancer patients and their caregivers. For more information, visit www.ArizonaOncology.com.
Arizona Oncology is a practice in The US Oncology Network (The Network). This collaboration unites the practice with more than 1,200 independent physicians dedicated to delivering value-based, integrated care to patients — close to home. Through The Network, these independent doctors come together to form a community of shared expertise and resources dedicated to advancing local cancer care and to delivering better patient outcomes. The Network is supported by McKesson Corporation, whose coordinated resources and infrastructure allow doctors in The Network to focus on the health of their patients, while McKesson focuses on the health of their practices. Arizona Oncology also participates in clinical trials through US Oncology Research, which has played a role in more than 95 FDA-approved cancer therapies.