Progress In Record Numbers Of Approved Therapies For Gynecologic Cancers: The Lack Of Upfront Approval For Newly Diagnosed Cases.

e14551 Background: To determine progress in FDA approved drugs for cancer therapies in over the past 12 years. Methods: Data from all approved oncologic or malignant hematologic indications were obtained from the FDA between 2006 and 2017. Results: Of 186 FDA approved oncologic New Drug and Biologic License Applications, 68% (n = 127) for solid and 32% (n = 59) liquid tumors. Based on the classes of drugs, 69 were small molecule, 67 monoclonal antibodies, 36 cytotoxics, 31 immunotherapies, 3 antibody drug conjugates, 5 hormones, 2 were others. 12% (n = 22) were for female cancers and 3% (n = 5) were for male cancers. To evaluate trends, we divided the study into three time periods based on the year of submission: 2006–2009, 2010–2013, and 2014–2017 and showed that the number of drugs approved increased from 44 (24%), 59 (32%), and 83 (45%) respectively. Drugs approved for female cancers increased from 6(27%), 7(32%), and 9(41%). Based on class of drug, there was an increase in small molecules (12 to 27 to 30) and monoclonal antibodies (12 to 11 to 17), immunotherapeutics (2 to 4 to 25) with corresponding decrease in chemotherapies (16 to 11 to 9) (p < 0.001). Over the three time periods, 2, 1, and 5 drugs were approved for gynecologic cancers; including 2 (topotecan and gemcitabine combination for cervix), 1 (liposomal doxorubicin generic for ovary), and 5 (bevacizumab for cervix, recurrent ovary, olaparib for recurrent and maintenance ovary, rucaparib for recurrent ovary, niraparib for maintenance ovary, and pembrolizumab for MSI positive uterine cancer). Although there is a significant increase in the new drug licenses with 8 new indications over the last 3 years, these approvals have been restricted to those with metastatic, recurrent, refractory, and biomarker only and after multiple failed lines of therapies. In fact, there were no approvals for gynecologic cancers in the upfront and setting, whereas 3 of 14 (21%) of breast cancer approvals were newly diagnosed disease. Conclusions: The FDA approval of new drugs and indications for gynecologic cancers have increased significantly over time; however, novel treatment are warranted for those with upfront and newly diagnosed cancers