Novartis receives FDA Breakthrough Therapy designation for investigational 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC)

Novartis announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to 177Lu-PSMA-617, an investigational radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC).  Breakthrough Therapy designation is granted to medicines being evaluated for serious conditions where early clinical evidence indicates the potential for substantial improvement over available therapy1.

  • Breakthrough therapy designation granted based on positive data from the pivotal, Phase III VISION …
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