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GEN-1 immunotherapy demonstrated dose-dependent efficacy results in newly diagnosed patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer when treated in combination with the standard of care, according to results from the OVATION 2 study. Based on positive data in the phase I portion, the study is moving on to phase II with enrollment expected to begin in the second half of the year.

The FDA has granted a Fast Track designation for the evaluation of balstilimab in combination with zalifrelimab for the treatment of patients with relapsed or refractory metastatic cervical cancer, according to a press release from Agenus, Inc., the developer of balstilimab. Comprehensive data supporting the potential of the combination served as the basis for the designation.

The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.

In an interview with Targeted Oncology, Alexandra S. Bercow, MD, discussed the results from a retrospective study, which evaluated the role of palliative care in women who died from cervical cancer between 2000 and 2017 at 2 institutions. She also highlighted the benefit of palliative care and why this patient population could benefit more than those with ovarian or endometrial cancers.

In February 2020, the FDA gave indications to multiple therapies meant for treatment of solid tumor and hematologic malignancies. FDA action included 10 Priority Reviews, 2 Breakthrough Therapy designations, and 2 Fast Track designations.

In January 2020, the FDA approved new treatment options in gastrointestinal stromal tumors, bladder cancer, and epithelioid sarcoma. The FDA also granted several Priority Review Designations, orphan drug designations, and a Fast Track designation, as well as a Breakthrough Therapy designation.

Research has shown that patients with para-aortic lymph node metastasis, human papillomavirus-18, and those with certain histocompatibility genes in their cervical tumors also have a poor prognosis. Preclinical research suggests, however, that immune checkpoint blockade with radiation can enhance immune-mediated activity in patients who have up to stage IV disease.