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Jonathan Ledermann, MD, professor of medical oncology, UCL Cancer Institute, London, United Kingdom, discusses phase III results of a study of rucaparib versus placebo following response to platinum-based chemotherapy for recurrent ovarian cancer.

According to research recently reported at the European Society of Gynaecological Oncology 2017 Congress, deleterious mutations in the PALB2 gene may account for development of breast cancer in women with an elevated risk due to a family history of breast or ovarian cancer, but who test negative for the BRCA1 or BRCA2 genes.

Based on results from the phase III ARIEL3 trial, in which maintenance rucaparib improved median progression-free survival by 11.2 months versus placebo for patients with <em>BRCA</em>-mutant platinum-sensitive ovarian cancer, the FDA has granted the PARP inhibitor a priority review.

According to results of a survey reported at the European Society of Gynaecological Oncology 2017 Congress, patients with ovarian cancer are more likely to opt to receive maintenance therapy if it could offer delay of disease progression and allow them to maintain or improve their quality of life.

Jonathan Ledermann, MD, discusses results of the phase III ARIEL3 study, as well as the future of PARP inhibitors in the maintenance setting for patients with ovarian cancer.

Niraparib (Zejula) has been approved by the European Commission as a maintenance therapy for women with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy, Tesaro, the manufacturer of the treatment, has announced.

Maurie Markman, MD, president of medicine and science, Cancer Treatment Centers of America, discusses valuable endpoints beyond overall survival (OS) that can be used in ovarian cancer clinical trials.

Maurie Markman, MD, president of medicine and science, Cancer Treatment Centers of America, discusses overall survival as an endpoint in ovarian cancer.

According to results reported at the 2017 international meeting of the European Society of Gynaecological Oncology (ESGO 20), maintenance therapy with olaparib monotherapy was safe and provided clinically significant, long-term treatment benefits in patients with platinum-sensitive relapsed serous ovarian cancer.

PARP inhibitors offer great potential to improve outcomes for patients with ovarian cancer, and evidence will hopefully support their use in the first-line management of these patients, said Susana M. Campos, MD, a gynecologic oncologist at Dana-Farber Cancer Institute and an assistant professor at Harvard Medical School, during her talk at the 35th annual CFS<sup>®</sup> meeting.

Ovarian cancer is the most lethal of the gynecologic malignancies. Over 22,000 new cases of ovarian cancer are diagnosed each year in the United States, resulting in more than 14,000 deaths per year.

A supplemental biologics application for bevacizumab (Avastin) has been accepted by the FDA for the first-line treatment of advanced ovarian cancer, according to Genentech, the manufacturer of the angiogenesis inhibitor.

Julia Elvin, MD, PhD, vice president and senior associate medical director, Foundation Medicine, discusses a study that explored the different characteristics of subtypes of ovarian cancer, peritoneal tumors, and fallopian tube tumors.

Peter R. Dottino, MD, discusses the utilization of molecular methods to identify ovarian cancer following treatment with chemotherapy, and how this type of research impacts the field going forward.

Researchers in the Perelman School of Medicine at the University of Pennsylvania evaluated the genetic profiles of 160 breast and ovarian cancers associated with germline mutations in <em>BRCA1 </em>and <em>BRCA2 </em>and determined that there is a relationship between the genetics of <em>BRCA 1/2 </em>mutations and the risk of resistance to platinum-based chemotherapy.

Based on findings from the phase III ARIEL3 trial, a supplemental new drug application has been submitted to the FDA for rucaparib as maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Douglas A. Levine, MD, professor, Department of Obstetrics and Gynecology, and director, Division of Gynecologic Oncology, NYU Langone Medical Center, discusses the efficacy of niraparib (Zejula) on progression-free survival in patients with recurrent ovarian cancer with partial response to the last platinum-based chemotherapy.

Dmitriy Zamarin, MD, PhD, discusses the potential for immunotherapy in the treatment of ovarian cancer.

There is genuine excitement within the gynecologic cancer clinical and research communities for the potential role of PARP inhibitors in the management of ovarian cancer.

Michael J. Birrer, MD, PhD, discusses the introduction of poly ADP-ribose polymerase inhibitors to the ovarian cancer treatment landscape.

Investigators recently evaluated the genetic profiles of 160 breast and ovarian cancers associated with germline mutations in <em>BRCA1 </em>and <em>BRCA2 </em>and<em> </em>determined that there is a relationship between the genetics of <em>BRCA</em>1/2 mutations and the risk of resistance to platinum-based chemotherapy.

Today, ABP-215, a biosimilar for bevacizumab developed by Amgen and Allergan, received FDA approval for the treatment of several different cancer types, making it the first biosimilar approved for the treatment of cancer.

The PARP inhibitor Rucaparib (Rubraca) improved median progression-free survival by 11.2 months compared with placebo as a maintenance treatment for patients with <em>BRCA</em>-mutant platinum-sensitive ovarian cancer, according to findings from the phase III ARIEL3 trial presented at the 2017 ESMO Congress.

Jonathan Ledermann, MD, professor of medical oncology in the University College London Cancer Institute and director of Cancer Research UK and UCL Cancer Trials Centre, discusses the toxicities associated with rucaparib (Rubraca) for the treatment of ovarian cancer.

A look back at all the FDA news that occurred in the month of August.



































