FDA Expands Indication for Lutetium Lu 177 Vipivotide Tetraxetan in mCRPC

Breaking News: Expanded FDA Approval of 177Lutetium-PSMA-617

What this means for patients: Today, the therapy 177lutetium-PSMA-617 (Lu-PSMA; trade name Pluvicto®) was approved by the FDA for patients with advanced (metastatic) prostate cancer who have been treated with androgen receptor pathway inhibitor therapy. This medicine delivers a small dose of radiation attached to a molecule that specifically binds to prostate cancer cells. It has been shown to slow disease progression and maintain quality of lif…

177Lu-PSMA-617 Approved for PSMA+ mCRPC

Indications for 177Lu-PSMA-617 now include taxane-based chemotherapy naive adults with PSMA+ mCRPC.

FDA Expands Indication for Lutetium-177 PSMA-617 in PSMA-Positive mCRPC

The FDA approved 177Lu PSMA-617 for prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer after androgen therapy.

FDA Approves Radioligand Therapy in PSMA–Positive, Castration-Resistant PC

Results from PSMAfore show that lutetium Lu 177 vipivotide tetraxetan elicited a median rPFS of 9.3 months vs 5.6 months with ARPI in prostate cancer.

FDA Expands Indication for Lutetium Lu 177 Vipivotide Tetraxetan in mCRPC

The FDA has expanded the indication for lutetium Lu 177 vipivotide tetraxetan for use in additional patients with PSMA-positive metastatic castration-resistant prostate cancer.

Addressing Remaining Unmet Needs in mCRPC

Panelists discuss how future trials in metastatic castration-resistant prostate cancer (mCRPC) should focus on developing reliable biomarker-driven treatment selection strategies to optimize sequencing decisions and identify which patients will benefit most from specific therapies or combinations, particularly as the treatment landscape becomes increasingly complex.