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On Wednesday, the FDA approved the first targeted therapeutic radioligand for progressive, metastatic castration-resistant prostate cancer (mCRPC) with prostate-specific membrane antigen (PSMA) expression.

Consisting of a targeting compound and a therapeutic radioisotope, lutetium Lu 177 vipivotide tetraxetan (Pluvicto) hones in on PSMA-expressing mCRPC, as identified by a companion diagnostic test (gallium Ga 68 Gozetotide injection, Locametz), which was approved at the same time. The pertains to patients previously treated with androgen receptor pathway inhibitors and taxane-based chemotherapy.

"The approval of Pluvicto is an important clinical advancement for people with progressing mCRPC, as it can significantly improve survival rates for those who have limited treatment options," said Oliver Sartor, MD, of Tulane Cancer Center in New Orleans, in a from Novartis. "Pluvicto is a step forward in the evolution of precision medicine for prostate cancer."

Support for the approval came from the international phase III VISION trial that compared standard of care with or without the radioligand therapy in 831 patients with previously treated PSMA-positive mCRPC. The primary analysis showed that the addition of lutetium Lu 177 vipivotide tetraxetan significantly improved median overall survival from 11.3 months to 15.3 months, representing a 38% reduction in the mortality hazard (95% CI 0.52-0.74, P<0.001). Radiographic progression-free survival improved from 3.4 to 8.7 months, a 60% reduction in the hazard for progression or death (99.2% CI 0.29-0.57, P<0.001).

The most common adverse reactions (≥20% of patients) occurring more often with the targeted radioligand were fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation.

According to Novartis, the drug will be available "within weeks." Two phase III trials of lutetium Lu 177 vipivotide tetraxetan in earlier-stage disease are ongoing.

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