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The FDA approved several indications in the month of June, including venetoclax (Venclexta) in chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL), the combination of binimetinib (Mektovi) plus encorafenib (Braftovi) in melanoma, and bevacizumab (Avastin) in ovarian cancer. The FDA also accelerated approvals for pembrolizumab (Keytruda) in cervical cancer and in primary mediastinal large B-cell lymphoma, while also granting a priority review to glasdegib for acute myeloid leukemia.

In findings from the randomized phase III SOLO-1 trial, olaparib (Lynparza) tablets reduced the risk of disease progression or death compared with placebo as frontline maintenance therapy for women with <em>BRCA</em>-positive advanced ovarian cancer.









Christa Dominick, MD, a gynecologic oncology fellow at University Hospitals, discusses the rationale behind this trial and the results. She also highlights her plans moving forward with other trials involving the cowpea mosaic virus in ovarian cancer.<br />

Mario M. Leitao, Jr, MD, FACOG, FACS, program director of Gynecologic Oncology at Memorial Sloan Kettering Cancer Center, highlights some of the phase I and II clinical trials in ovarian cancer currently enrolling at his institution. He also discusses the rationale behind a new trial that is expected to open soon.

Based on results from the phase III GOG-0218 trial, bevacizumab (Avastin) has been approved by the FDA for use in combination with carboplatin and paclitaxel, followed by bevacizumab monotherapy, for the treatment of women with advanced ovarian cancer following initial surgical resection.

An important step for treatment of patients with ovarian cancer has been testing for genetic alterations. Mike Janicek, MD, says that the use of genetic testing must become more common in order to push the field of ovarian cancer forward.

Patients with relapsed, advanced, high-grade ovarian cancer achieved durable responses with the PARP inhibitor niraparib (Zejula) as fourth-line therapy and beyond, the phase II QUADRA trial showed.

Ursula A. Matulonis, MD, director, Gynecologic Oncology, Dana-Farber Cancer Institute, professor of Medicine, Harvard Medical School, discusses results from the phase II open-label, single-arm QUADRA study evaluating niraparib in patients with relapsed ovarian cancer who have received ≥3 prior chemotherapy regimens during the 2018 ASCO Annual Meeting.

The frontline treatment of patients with ovarian cancer may potentially change in the near future, with targeted and immunotherapy strategies showing promising signals of activity.

Brian Burgess, DO, PhD, a first-year fellow at the University of Kentucky, discusses the biggest challenge with targeted therapies in ovarian cancer. PARP resistance has become a huge barrier in this treatment paradigm.

Mario M. Leitao, Jr, MD, FACOG, FACS, program director of Gynecologic Oncology at Memorial Sloan Kettering Cancer Center, discusses what is currently being investigated in the treatment landscape of ovarian cancers.

According to top-line results from the QUADRA study, niraparib met the primary endpoint of overall response as a fourth-line or later treatment in patients with ovarian cancer, regardless of <em>BRCA</em> status.

Olaparib tablets have been approved been the European Commission as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy, regardless of <em>BRCA</em> status.

Kathleen Essel, MD, a fellow at University of Oklahoma Health Science Center, discusses the findings from a recent trial investigating the safety of long-term treatment with bevacizumab in patients with ovarian cancer.

The FDA approved several indications throughout the month of April 2018. A number of drugs were granted priority review and Fast Track designation. The FDA also halted all clinical trials using tazemetostat as treatment, and new initiatives were introduced to help ease the development of genetic and genomic-based tests. Check out our list of all FDA happenings from April 2018.

Based on findings from the phase III ARIEL3 trial, rucaparib (Rubraca) tablets have been approved by the FDA for use as a maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, according to Clovis Oncology, the manufacturer of the PARP inhibitor.

According to initial results presented at the 2018 Society of Gynecologic Oncology Annual Meeting, 43% of the first 14 patients with platinum-resistant epithelial ovarian cancer treated with the combination of pembrolizumab (Keytruda) and mirvetuximab soravtansine (IMGN853), a folate receptor-alpha antibody drug conjugate, had partial responses.




















































