Pluvicto FDA Approval History
Last updated by Judith Stewart, BPharm on April 5, 2022.
FDA Approved: Yes (First approved March 23, 2022)
Brand name: Pluvicto
Generic name: lutetium lu 177 vipivotide tetraxetan
Dosage form: Injection
Company: Novartis Pharmaceuticals Corporation
Treatment for: Prostate Cancer
Pluvicto (lutetium lu 177 vipivotide tetraxetan) is a radioligand therapeutic agent indicated for the treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
- PSMA is highly expressed in more than 80 percent of patients with prostate cancer. PSMA-positive lesions are identified through a positron emission tomography (PET) scan using the complementary diagnostic imaging agent, Locametz (kit for the preparation of gallium Ga 68 gozetotide injection). Gallium-68 labeled Locametz can identify tumor lesions expressing the PSMA biomarker and locate where in the body tumors may have spread.
- Pluvicto is a precision cancer treatment that combines a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle). Pluvicto works by binding to the target cells (prostate cancer cells that express PSMA) where energy emissions from the radioisotope cause disruption to cell replication and/or cell death.
- Pluvicto is used in patients who have been previously treated with androgen receptor pathway inhibition and taxane-based chemotherapy. Pluvicto is administered via intravenous injection every 6 weeks for up to 6 doses.
- Pluvicto is associated with the following warnings and precautions: risk of radiation exposure, myelosuppression, renal toxicity, embryo-fetal toxicity, and infertility.
- Common adverse reactions include fatigue, dry mouth, nausea, anemia, decreased appetite, and constipation. Common laboratory abnormalities include decreased lymphocytes, decreased hemoglobin, decreased leukocytes, decreased platelets, decreased calcium, and decreased sodium.
Development timeline for Pluvicto
Further information
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