GYNECOLOGIC CANCERS

The FDA has granted priority review to 2 supplemental new drug applications for the combination use of pembrolizumab and lenvatinib.

In an interview with Targeted Oncology, Ursula A. Matulonis, MD, discusses results from further follow-up of patients with ovarian cancer treated in the ENGOT-OV16/NOVA.

Here is a look back at the FDA happenings from the month of April 2021.

A leader in gynecologic oncology, Chirag Shah, MD, MPH, provides insight into the future of ovarian cancer by discussing the potential for immunotherapy, TP53 inhibition, and novel therapeutics on the horizon.

Chirag Shah, MD, MPH, discusses platinum sensitivity vs resistance impact treatment selection in subsequent lines of therapy.

An expert in gynecologic oncology reviews the PRIMA and NOVA clinical trials and discusses their implications for the management of ovarian cancer.

Chirag Shah, MD, MPH, provides key insights into factors to consider when counseling patients with ovarian cancer on the available treatment options for maintenance therapy.

Key opinion leader in obstetrics and gynecology Chirag Shah, MD, MPH, discusses best practices for molecular testing and genetic counseling for patients with newly diagnosed or relapsed ovarian cancer.

Chirag Shah, MD, MPH shares insight into factors influencing the prognosis of patients with ovarian cancer.

Chirag Shah, MD, MPH, an expert in gynecologic oncology, provides an overview of the case of a 67-year-old woman with ovarian cancer by reviewing the patient’s initial presentation, clinical work-up, and treatment.

Chirag Shah, MD, MPH, an expert in gynecologic oncology, reviews the case of a 67-year-old woman with ovarian cancer and discusses factors to consider when selecting therapy including the recent results of the PRIMA and NOVA trials of niraparib in patients with ovarian cancer.

The FDA has approved the VENTANA MMR RxDX panel, a device that determines if patients with advanced or recurrent endometrial cancer are eligible for treatment with dostarlimab-gxly monotherapy.

The FDA has granted accelerated approval to dostarlimab-gxly for the treatment of adult patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR, as determined by an FDA approved test.

William H. Bradley, MD discusses the 5-year follow-up of the ongoing SOLO-1 trial, which is determining the efficacy of maintenance olaparib in patients with BRCA1/2-mutated advanced ovarian cancer.

In an interview with Targeted Oncology, Katelyn Handley, MD, discussed two studies on ovarian cancer subtypes and the use of a frailty index to determine patient outcomes before, during, and after ovarian cancer debulking surgery.

A patient with ovarian cancer has begun treatment with oral endoxifen, an active metabolite of tamoxifen, after a Safe to Proceed Letter was granted by the FDA, according to a press release by Atossa Therapeutics, Inc.

The FDA has accepted a biologics license application and granted it a priority review for tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

In women with advanced epithelial ovarian cancer treated in a single-institution study at the Cleveland Clinic, the addition of paclitaxel to cisplatin for hyperthermic intraperitoneal chemotherapy during interval debulking surgery was associated with improved oncologic outcomes compared with cisplatin alone.

No statistically significant difference was seen with the combination of olaparib and cediranib compared to cediranib alone in patients with recurrent, metastatic or persistent endometrial cancer.

Data from the KEYNOTE-158 study, presented at the Society of Gynecological Oncology 2021 Virtual Annual Meeting on Women’s Cancer, showed durable responses in heavily pretreated patients with vulvar squamous cell carcinoma regardless of their PD-L1 status.

Patients with advanced or recurrent endometrioid endometrial cancer had promising clinical outcomes following treatment with the combination of enzalutamide and carboplatin plus paclitaxel in the phase 2 ENPAC clinical trial.

Niraparib administered as maintenance therapy showed clinical benefit lasting beyond first progression in patients with platinum-sensitive recurrent ovarian cancer with or without germline BRCA mutations, according to the final results of the ENGOT-OV16/NOVA study.

Olaparib maintenance continues to show clinical activity in platinum-sensitive ovarian cancer, including in patients with somatic BRCA mutations and non-BRCA homologous recombination repair mutations.

In a phase 2 trial treatment with eribulin led to disease control and a favorable safety profile among patients with recurrent or advanced cervical cancer.

At the Society of Gynecological Oncology Virtual Annual Meeting on Women’s Cancer data from the phase II OVARIO study continued to show the progression free survival benefit for heavily pretreated patients with advanced ovarian cancer.