FDA accepts NDA for UGN-102 (mitomycin) for intravesical solution for the treatment of LG-IR-NMIBC; PDUFA goal date: Jun 2025 October 22, 2024
Accelerated approval for Trodelvy® (sacituzumab govitecan-hziy) for patients with locally advanced or metastatic urothelial cancer refractory to platinum-containing chemo and PD-1/PD-L1 inhibitor withdrawn October 22, 2024
Multiple Clinical Complete Responses Demonstrated Following Single Low Dose Administration of Bel-sar in Patients with NMIBC in Ongoing Ph 1 Trial October 22, 2024
Positive guidance from the U.S. FDA on 64Cu-SAR-bisPSMA Ph 3 trial in patients with recurrence of prostate cancer October 22, 2024
Ph 3 SunRISe-2 trial in MIBC patients discontinued for not showing superiority versus chemoradiation October 15, 2024
Exelixis and Merck to Evaluate Zanzalintinib in Combination With KEYTRUDA in Head and Neck Cancer and in Combination With WELIREG in RCC October 15, 2024
IV Opdivo Approved in Taiwan in Combination with Cisplatin & Gemcitabine for the 1L Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma October 15, 2024
First Patient Dosed in Ph 3 Clinical Trial of UGN-103 in patients with Low-Grade Intermediate-Risk NMIBC October 8, 2024
ERLEADA® (apalutamide) demonstrates statistically significant and clinically meaningful improvement in OS compared to enzalutamide in patients with mCSPC October 8, 2024
Arcus Biosciences Announces Clinical Trial Collaboration Agreement to Evaluate Casdatifan in Combination with Volrustomig in RCC October 8, 2024
Supplemental NDA submitted to FDA for darolutamide + ADT combo in patients with mHSPC October 1, 2024
KEYTRUDA Receives New Approvals in Japan for perioperative Patients With NSCLC and in Radically Unresectable Urothelial Carcinoma October 1, 2024
Ph 2 Results for Two Additional Cancer Cohorts and Correlative Biomarker Data from 23ME-00610 Study Announced September 24, 2024
Trials evaluating ONCT-534 in metastatic CRPC & ONCT-808 in BCL discontinued to explore strategic alternative September 18, 2024
GI Innovation Announces New Clinical Trial Collaboration and Supply Agreement to Evaluate GI-102 + KEYTRUDA in Patients with IO-Resistant HCC, Melanoma, and RCC September 3, 2024
CDE of NMPA Approves to Initiate Ph 3 Trial of 9MW2821 for Urothelial Carcinoma in Combination with PD-1 Inhibitor September 3, 2024
European Commission Approves PADCEV (enfortumab vedotin) + KEYTRUDA (pembrolizumab) for First-Line Treatment of Advanced Urothelial Cancer September 3, 2024
European Commission approves BALVERSA (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma August 27, 2024
Vobramitamab Duocarmazine Update Provided; treatment recently discontinued for TAMARACK metastatic CRPC patients who remained eligible for further dosing August 7, 2024
Positive EU CHMP Opinion for KEYTRUDA + Padcev as 1L Treatment for Patients With Unresectable or Metastatic Urothelial Carcinoma July 30, 2024
Darolutamide meets primary endpoint in Ph 3 ARANOTE trial in men with metastatic hormone-sensitive prostate cancer July 23, 2024
