177Lu-PSMA-617 is an investigational radioligand therapy intended for metastatic castration-resistant prostate cancer (mCRPC)
The new Novartis Pavillon on the Novartis Campus in Basel. (Credit: Novartis AG.)
Novartis has received the US Food and Drug Administration (FDA) Breakthrough Therapy designation (BTD) for its 177Lu-PSMA-617 to treat a type of prostate cancer.
177Lu-PSMA-617 is an investigational radioligand therapy designated for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
FDA grants Breakthrough Therapy designation to medicines for serious conditions, whose early clinical evidence indicate potential improvement over existing therapy.
The current BTD was based on positive results from the Phase 3 VISION study which evaluated 177Lu-PSMA-617 plus standard of care (SOC), compared to SOC alone.
In the Phase 3 VISION study, treatment using 177Lu-PSMA-617 significantly improved overall survival and radiographic progression-free survival in men with progressive PSMA-positive mCRPC2.
According to the study findings, the five-year survival rate for patients with metastatic prostate cancer is nearly 30%.
Novartis said that it specialises in radioligand therapy, with wide-ranging commercial experience, established manufacturing capabilities, and extensive development expertise.
The company is currently carrying out additional studies with 177Lu-PSMA-617 radioligand therapy in earlier lines of treatment for metastatic prostate cancer.
It is evaluating the potential clinical utility of the drug in the mCRPC pre-taxane (PSMAfore) setting and the metastatic hormone-sensitive (PSMAddition).
In March this year, Novartis has received the European Commission (EC) approval for Kesimpta to treat relapsing forms of multiple sclerosis (RMS) in adults with active disease.