FDA Accepts Supplemental BLA for PADCEV® (enfortumab vedotin-ejfv) + KEYTRUDA for 1L Locally Advanced or Metastatic Urothelial Cancer patients January 4, 2023
FDA approved Adstiladrin for High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer January 4, 2023
Lynparza + abiraterone approved in the EU in 1L metastatic CRPC based on Ph 3 PROpel trial results January 4, 2023
PDUFA date extended by three months to review Lynparza + abiraterone & prednisone supplemental NDA for metastatic CRPC December 19, 2022
European Commission Approves Pluvicto® For Treatment Of Progressive PSMA+ve metastatic CRPC December 19, 2022
Pluvicto™ shows statistically significant & clinically meaningful rPFS benefit in patients with PSMA+ve metastatic CRPC December 12, 2022
New Data from the OPTIMA II Study Shows mDOR of 24.4 Months for UGN-102 in patients with Low-Grade, Intermediate-Risk Non-Muscle Invasive Bladder Cancer December 12, 2022
Immutep Enters into 2nd Clinical Trial Collaboration Agreement with Merck & Pfizer for New trial of Eftilagimod Alpha and Avelumab to Treat Urothelial Cancer December 5, 2022
New Data from the OLYMPUS Trial Shows mDOR of 28.9 Months for JELMYTO for Adults with Low-Grade Upper Tract Urothelial Cancer December 5, 2022
U.S. indication of Tecentriq® for the treatment of cisplatin-ineligible, PD-L1+ve adults with locally advanced or mUC to be withdrawn December 5, 2022
Lantheus and POINT Biopharma Announce Strategic Collaboration and Exclusive License Agreements for the Commercialization of PNT2002 & PNT2003 November 23, 2022
Lynparza – abiraterone combo recommended for approval in the EU by CHMP in 1L metastatic CRPC November 23, 2022
Exelixis and Catalent Enter into New License Agreement for Three Antibody-Drug Conjugate Programs with the Potential to Accelerate Exelixis’ Biologics Pipeline November 16, 2022
First Patient Successfully Dosed in Ph 1 Study of Pindnarulex in Combination with Talazoparib for the Treatment of Prostate Cancer November 16, 2022
Enrollment into Ph 1 study of EPI-7386 with apalutamide/abiraterone acetate plus prednisone in metastatic CRPC patients suspended due to operational recruitment challenges November 16, 2022
TRITON3 Ph 3 Trial Of Rubraca Achieves Primary Endpoint In Men With metastatic CRPC With BRCA Or ATM Mutations October 12, 2022
Ph 3 TALAPRO-2 study of TALZENNA® + XTANDI® in metastatic CRPC patients met primary endpoint of rPFS vs placebo plus XTANDI October 12, 2022
Detailed Results from Ph 3 COSMIC-313 Pivotal Trial in Patients with 1L RCC announced September 13, 2022
Results of Clinical Trial Investigating PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA and PADCEV as Monotherapy in 1L Advanced Urothelial Cancer September 13, 2022
Modi-1 Ph 1/2 trial open for recruitment in patients with TNBC, ovarian cancer, head and neck cancer, and RCC April 12, 2022
