Shots: The approval is based on two prospective studies assessing Ga 68 PSMA-11 in 960 men with prostate cancer. The first trial enrolled 325 patients & the second trial enrolled […]readmore
Tags : Men
Shots: The EC’s approval is based on P-III ARAMIS study assessing Nubeqa (600mg, bid) + ADT vs PBO + ADT 1,509 patients in a ratio (2:1) with nmCRPC The P-III […]readmore
Shots: The approval is based on P-III ARAMIS study assessing Nubeqa (600mg, qd) + ADT vs PBO + ADT in 1,509 patients in a ratio (2:1) with nmCRPC The P-III […]readmore
Regulatory
Astellas’ Xtandi (enzalutamide) Receives NMPA’s Approval for Metastatic Castration-Resistant Prostate
Shots: The approval is based on P-III Asian PREVAIL study assessing Xtandi (160mg/day) vs PBO + GnRH therapy or after bilateral orchiectomy in patients with progressive metastatic mCRPC who had […]readmore
Shots: The P-III HERO study involves assessing of Relugolix (360mg loading dose followed by 120mg, qd) vs leuprolide acetate (3mos. depot injection) in men in ratio 2:1 with androgen-sensitive advanced […]readmore
Shots: Myriad to seek approval based on the P-III PROfound results assessing Lynparza vs enzalutamide or abiraterone acetate in patients with metastatic castration-resistant prostate cancer who have failed prior treatment […]readmore
Shots: The approval is based on P-III ARAMIS study results assessing Nubeqa (600mg, bid) + ADT vs PBO + ADT in 1,509 in patients in a ratio (2:1) with nmCRPC. […]readmore
Shots: Arvinas’ ARV-110 is an orally available PROTAC protein degrader used for targeting androgen receptor (AR) protein and is currently evaluated in P-I for its safety, tolerability, and PK in […]readmore
Shots: The P-IV PLUS study involves assessing of Mirabegron(25mg,50mg) vs PBO in 715 men patients with overactive bladder (OAB) symptoms receiving tamsulosin for lower urinary tract symptoms (LUTS) due to […]readmore
Shots: The approval is based on P-III inTUNE clinical trial assessing Jatenzo vs Axiron in 222 patients in ratio (3:1) for patients with hypogonadal male in adults The study resulted: […]readmore