Novartis’ radioligand therapy granted US Breakthrough Therapy Designation
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.
Patients receiving Lu-PSMA-617 also demonstrated a statistically significant 60% risk reduction for radiographic PFS or death compared to best SoC only arm.
However, there was a higher rate of drug-related treatment emergent adverse events reported in the Lu-PSMA-617 treatment arm – 85.3% – compared to SoC alone – 28.8%.
Read more:https://www.pharmatimes.com/news/novartis_radioligand_therapy_granted_us_breakthrough_therapy_designation_1371903
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.
Patients receiving Lu-PSMA-617 also demonstrated a statistically significant 60% risk reduction for radiographic PFS or death compared to best SoC only arm.
However, there was a higher rate of drug-related treatment emergent adverse events reported in the Lu-PSMA-617 treatment arm – 85.3% – compared to SoC alone – 28.8%.
Read more:https://www.pharmatimes.com/news/novartis_radioligand_therapy_granted_us_breakthrough_therapy_designation_1371903