PLUVICTO

批准信原文要点

This corrected action letter incorporates the correction of the error. The effective action date will remain July 31, 2026, the date of the original letter. This Prior Approval supplemental new drug application provides for … In combination with ARPI therapy, for the treatment of adult patients with PSMA-positive metastatic androgen pathway modulation-naive or -sensitive (mAPMN/S) prostate cancer.

批准信原文要点

This Prior Approval sNDA updates the Pluvicto US Prescribing Information (USPI), specifically Section 2.6, "Table 2: Estimated Radiation Absorbed Dose for PLUVICTO in VISION," based on an updated dosimetry report.

批准信原文要点

These Prior Approval sNDAs provide for the following: • S-021: Revising the indication to treatment of adult patients with PSMA-positive mCRPC who have been treated with ARPI therapy, and are considered appropriate to delay taxane-based chemotherapy, or have received prior taxane-based chemotherapy, based on … PSMAfore. • S-024: Revising the USPI based on the final clinical study report for … VISION, which adds new adverse drug reactions and preferred terms.

批准信原文要点

These Prior Approval sNDAs provide for the following: • S-021: Revising the indication to treatment of adult patients with PSMA-positive mCRPC who have been treated with ARPI therapy… based on … PSMAfore. • S-024: Revising the USPI based on … VISION, which adds new adverse drug reactions and preferred terms.