First Patient Dosed in Ph 1a Trial of QN-302 in Advanced or Metastatic Solid Tumors December 11, 2023
Both FDA Fast Track and Breakthrough Therapy Designation for Cretostimogene Grenadenorepvec in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer December 11, 2023
TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer December 11, 2023
FDA Accepts for Priority Review Application for Opdivo + Cisplatin-Based Chemo for the 1L Treatment of Adult Patients with Unresectable/Metastatic urothelial carcinoma December 11, 2023
New Data Show Durable Response Following Treatment with ADSTILADRIN® (nadofaragene firadenovec-vncg) December 11, 2023
Data from Ph 1/2 APEX-01 Dose Escalation Study of ARX517 in metastatic CRPC announced December 11, 2023
FDA Grants Priority Review to Supplemental BLA for KEYTRUDA Plus PADCEV for the 1L Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer December 4, 2023
Subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types December 4, 2023
KEYTRUDA Significantly Improved OS Versus Placebo as Adjuvant Therapy for Certain Patients With RCC Following Nephrectomy November 7, 2023
Novartis confirms unconstrained supply for Pluvicto® and continues to significantly expand the number of treatment centers October 31, 2023
FDA Granted Fast Track Designation for ONCT-534 for the Treatment of Metastatic CRPC October 31, 2023
Resubmission of BLA for N-803 + BCG for the treatment of BCG-unresponsive NMIBC accepted; new PDUFA date of April 23, 2024 October 31, 2023
First Patients Dosed in First-in-Human Ph 1 Study of FX-909 in Advanced Solid Tumors, Including Urothelial Cancer October 25, 2023
Ph 3 CheckMate-67T Trial of SC Nivolumab (nivolumab and hyaluronidase) Meets Co-Primary Endpoints in Advanced/Metastatic ccRCC October 25, 2023
Interim Safety and Immune Response Data from Ph 1/2 Trial of PDS0301 + Docetaxel in Metastatic Prostate Cancer announced October 16, 2023
Lilly to Acquire POINT Biopharma to Expand Oncology Capabilities into Next-Gen Radioligand Therapies October 11, 2023
KEYTRUDA® Met Primary Endpoint of DFS in Certain Patients With Muscle-Invasive Urothelial Carcinoma (MIUC) After Surgery October 11, 2023
FDA Accepts for Priority Review Supplemental NDA for WELIREG® (belzutifan) in Certain Previously Treated Patients With Advanced RCC October 11, 2023
Ph 2 Study of Masofaniten (EPI-7386) + Enzalutamide in Patients with Metastatic CRPC initiated September 26, 2023
First Patient in Ph 1b/2 ADVANCED-2 Trial of TARA-002 in NMIBC Patients with High Grade Carcinoma in Situ September 26, 2023
PADCEV and KEYTRUDA Significantly Improve OS and PFS in Patients With Previously Untreated Advanced Bladder Cancer in Ph 3 EV-302 Trial September 26, 2023
