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Novartis experimental prostate cancer drug gets FDA breakthrough designation

Novartis announced on Wednesday that the FDA granted Breakthrough Therapy designation to an experimental 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. 

Breakthrough Therapy designation is granted to medicines being evaluated for serious conditions where early clinical evidence indicates the 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 for men with progressive PSMA-positive mCRPC. 


Castrate-resistant prostate cancer is diagnosed when the disease keeps growing even though the amount of testosterone in the body has been reduced to very low levels. Cancer may also be found in other parts of the body. Current treatment goals are to control symptoms and slow progress. 

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


“Patients with metastatic castration-resistant prostate cancer have a less than 1 in 6 chance of surviving 5 years and need new treatment options,” John Tsai, head of global drug development and chief medical officer for Novartis, said following promising study 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 realize our commitment to reimagining medicine without the partnership of patients and their families.” 

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