#fdabreakthrough

Novartis’ radioligand therapy granted US Breakthrough Therapy Designation #Novartis #prostatecancer #FDAbreakthrough “Swiss pharma company Novartis has scored a Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration for its investigational radioligand therapy Lu-PSMA-617. The BTD has been granted for Lu-PSMA-617 as a potential treatment for metastatic castration-resistant prostate cancer (mCRPC). It was granted based on data from the Phase III VISION study, evaluating Lu-PSMA-617 plus standard of care (SoC), versus SoC alone, in patients with progressive PSMA-positive mCRPC. In this study, Lu-PSMA-617 demonstrated a significant improvement in overall survival (OS) and radiographic progression-free survival (PFS) for men with progressive PSMA-positive mCRPC. In the Lu-PSMA-617 arm, there was an estimated 38% reduction in the risk of death compared to the best SoC only arm.” #MSL #FSTP #MSLcert #medicalscienceliaison medical science liaison #Medicalaffairs medical affairs #Pharmacist #phd https://lnkd.in/d9Z3xEp https://www.instagram.com/p/CQanGdxjsiF/?utm_medium=tumblr