Pluvicto FDA approval for hormone-sensitive metastatic prostate cancer: Jul 31, 2026

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) was approved by the FDA on July 31, 2026 for with an androgen receptor pathway inhibitor, adults with PSMA-positive metastatic androgen pathway modulation-naive or -sensitive prostate cancer.

The FDA approved Pluvicto in combination with an androgen receptor pathway inhibitor for PSMA-positive metastatic prostate cancer that is androgen pathway modulation-naive or -sensitive, extending its use to an earlier stage of the disease.

Run-up into the decision (T-120 → T+5)

Key facts

Drugs@FDA records NDA 215833 supplement 37 (efficacy) for Pluvicto as approved on July 31, 2026, with the FDA's letter and the revised label posted (FDA letter, label). The label's new section 1.1 indicates Pluvicto in combination with androgen receptor pathway inhibitor therapy for adults with PSMA-positive metastatic androgen pathway modulation-naive or -sensitive (mAPMN/S) prostate cancer. Novartis stated no goal date for this supplement, so no early or late margin is published. This calendar carried the application as a pending "Q4 2026 (est.)" row with no source until a review on November 1, 2026; it is recorded here from the FDA's own record.

Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.

Primary source: FDA approval letter, NDA 215833 S-037

FDA record of the action: the FDA approved on July 31, 2026, per NDA 215833 SUPPL-37 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.