FDA places partial clinical hold on Ph 1 ZN-c3-001 in solid tumors, Ph 2 ZN-c3-005 (DENALI) study in platinum-resistant ovarian cancer (PROC) and Ph 2 ZN-c3-004 (TETON) study in uterine serous carcinoma (USC) of azenosertib June 25, 2024
FDA Approves KEYTRUDA® + Carboplatin + Paclitaxel as Treatment for Adult Patients With Primary Advanced or Recurrent Endometrial Carcinoma June 25, 2024
Imfinzi plus chemotherapy approved in the US for mismatch repair deficient advanced or recurrent endometrial cancer June 18, 2024
Positive Topline Results from Ph 2 PICCOLO Trial of Mirvetuximab Soravtansine (ELAHERE) for High FRα Expressing Platinum-Sensitive Ovarian Cancer Announced June 11, 2024
Fast Track Designation Granted by the FDA for Lunresertib in Combination with Camonsertib for the Treatment of Platinum-Resistant Ovarian Cancer June 11, 2024
Rolling Submission of NDA to FDA initiated for Seeking Accelerated Approval of Avutometinib and Defactinib Combination for the Treatment of Adult Patients with Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer May 29, 2024
FAILED TRIAL: Ph 3 KEYNOTE-B21 trial of adjuvant KEYTRUDA + chemo +/- RT did not meet primary endpoint of DFS in newly diagnosed, high-risk endometrial cancer after surgery with curative intent May 15, 2024
Randomized Portion (Part 2) of REFRαME-O1 Trial of luvelta for patients with platinum-resistant ovarian cancer (PROC) initiated May 7, 2024
Stenoparib Shows Clear Clinical Benefit and Achieves Significant Milestone with Early Conclusion of Ph 2 Trial in Advanced Ovarian Cancer May 7, 2024
Ph 2 trial of VB10.16 with or without Tecentriq initiated for the treatment of HPV16+ve, PD-L1+ve, recurrent or metastatic cervical cancer May 1, 2024
US FDA accepts for priority review Supplemental BLA of Jemperli (dostarlimab) + chemo to include all adult patients with primary advanced or recurrent endometrial cancer May 1, 2024
Positive Top-Line, Protocol-Planned Interim Report Data from the Study of Ampligen + Pembrolizumab for the Treatment of Recurrent Ovarian Cancer Announced April 16, 2024
REJOICE-Ovarian01 Ph 2/3 Trial of Raludotatug Deruxtecan Initiated in Platinum-Resistant Ovarian Cancer April 9, 2024
Stenoparib development Toward Regulatory Approval in Advanced Recurrent Ovarian Cancer Accelerated April 2, 2024
First patient dosed in Ph 1b/2 trial of LB-100 + dostarlimab-gxly in ovarian clear cell carcinoma March 26, 2024
Lynparza and Imfinzi demonstrated strong clinical benefit and more than doubled median duration of response vs. chemo in patients with MMR-proficient advanced or recurrent endometrial cancer March 26, 2024
FDA Grants Full Approval for ELAHERE® (mirvetuximab soravtansine-gynx) for FRα-positive, platinum-resistant ovarian cancer (PROC) March 26, 2024
IDEAYA to Evaluate IDE161 in Combination with KEYTRUDA in Patients with Endometrial Cancer March 18, 2024
KEYTRUDA + CRT Significantly Improved OS Versus CRT Alone in Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer March 18, 2024
Debio0123 Monotherapy trial expanded In Gynecological Cancers And Other Biomarker-Driven Solid Tumors March 12, 2024