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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%.
“Men with metastatic prostate cancer have an approximately 3 in 10 chance of surviving 5 years. These data from the first Phase III study of a radioligand therapy in this advanced prostate cancer setting confirm the potential of 177Lu-PSMA-617 targeted therapy to improve clinical outcomes,” said John Tsai, head of global drug development and chief medical officer for Novartis.
Novartis also has two additional studies with Lu-PSMA-617 in earlier lines of treatment for metastatic prostate cancer ongoing.
One of these studies is investigating the potential clinical utility of the radioligand therapy in the mCRPC pre-taxane treatment setting, while the second study is evaluating Lu-PSMA-617 in the metastatic hormone-sensitive setting.
A BTD is granted to medicines that are being evaluated for serious conditions, where early clinical evidence indicates the potential for substantial improvement over available therapy.