Novartis’ investigational prostate cancer drug achieves breakthrough designation from FDA

Novartis announced the Wednesday as the FDA granted the Breakthrough Therapy designation to an investigational therapy that targets advanced castration-resistant prostate cancer. The agency said the decision was based on positive data from a Phase 3 clinical trial evaluating LuPSMA-617.

The breakthrough therapy designation is granted to drugs under evaluation for serious conditions for which early clinical evidence indicates potential for substantial improvement over available therapy.

According to the company, the phase 3 VISION study demonstrated that the drug significantly improved overall survival and radiographic progression-free survival in men with progressive, PSMA-positive mCRPC.


Castration-resistant prostate cancer is diagnosed when the disease continues to grow even though the amount of testosterone in the body has been reduced to very low levels. Cancer can also be found in other parts of the body. The current treatment goals are to control symptoms and slow progress.

Patients in the study who received Lu-PSMA-617 above the standard of care did better than those who received only the standard of care. The company said the drug is a targeted therapeutic approach that delivers radiation directly to the tumor while limiting damage to surrounding normal tissue.


“Patients with metastatic castration-resistant prostate cancer have a less than a 1 in 6 chance of surviving 5 years and need new treatment options,” said John Tsai, head of global drug development and director medical report from Novartis, following the study’s promising results in March. “We would like to thank the patients who volunteered to participate in this study as well as the clinical teams at each of the trial sites. We would not be able to fulfill our commitment to reinvent medicine without the partnership of patients and their families.

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Louis Foulds

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