Shaily Arora, Preeti Narayan, Gwynn Ison, Tara Berman, Daniel L Suzman, Suparna Wedam, Tatiana M Prowell, Soma Ghosh, Reena Philip, Christy L Osgood, Jennifer J Gao, Mirat Shah, Danielle Krol, Sakar Wahby, Melanie Royce, Christina Brus, Erik W Bloomquist, Mallorie H Fiero, Shenghui Tang, Richard Pazdur, Amna Ibrahim, Laleh Amiri-Kordestani, Julia A Beaver
Over the last decade, there has been tremendous progress in the treatment of patients with gynecologic cancers with a changing therapy landscape. This summary provides an overview of U.S. Food and Drug Administration (FDA) approvals for gynecologic cancers from 2010 to 2020, totaling 17 new indications. For each of the approved indications, endpoints, trial design, results, and regulatory considerations are outlined. Among these 17 indications, six received accelerated approval (AA) and 11 received regular approval (RA)...
March 15, 2022: Clinical Cancer Research