medwireNews: The US FDA has authorized the use of lutetium-177 vipivotide tetraxetan for previously treated patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
Specifically, the PSMA-targeted radioligand therapy (Pluvicto, Advanced Accelerator Applications USA, Inc, Millburn, New Jersey) is indicated for adults who have progressed after treatment with androgen receptor pathway inhibitors and taxane-based chemotherapy.
The regulatory agency has also approved gallium-68 gozetotide (Locametz, Novartis, Basel, Switzerland), a radioactive diagnostic agent, noting that either this or another approved PSMA-11 imaging agent should be used to identify individuals with PSMA-positive tumors who can be given lutetium-177 vipivotide tetraxetan.
The decision is based on the phase 3 VISION trial, which showed a significant 38% decrease in the risk for death with the addition of lutetium-177 vipivotide tetraxetan to standard of care in this patient population.
It is recommended that lutetium-177 vipivotide tetraxetan be given at a dose of 7.4 GBq (200 mCi) intravenously every 6 weeks for up to six doses, or until disease progression or unacceptable toxicity.
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