Novartis Receives FDA Breakthrough Therapy Status for Prostate Cancer Candidates

Basel - The pharmaceutical company Novartis has received therapeutic breakthrough status from the US FDA for its product candidate 177Lu-PSMA-617. The compound is being researched and further developed for the treatment of patients with a specific form of metastatic castration-resistant prostate cancer (mCRPC).

The Breakthrough Therapy Designation status for radioligand therapy is based on positive data from the Phase III VISION study, Novartis announced on Wednesday. The drug, in combination with the best standard therapy (SOC), has shown, among other things, a significantly improved survival rate in patients with prostate cancer compared to SOC treatment alone.


Image by: Novartis
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