Novartis AG Sponsored ADR (NVS.US) Lutetium [177Lu] Dotatate Market Application Accepted by CDE

On November 13th, Novartis AG Sponsored ADR (NVS.US) Lu [177Lu] Prostate-Specific Membrane Antigen (PSMA) Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) treatment peptide was accepted for review by the Center for Drug Evaluation (CDE) in China. Prior to this, the drug had been granted priority review by the CDE and is indicated for use in adult patients with mCRPC who have received androgen receptor pathway inhibitors and taxane chemotherapy. This drug is the first FDA approved targeted radioligand therapy for patients with castration-resistant prostate cancer, and this is the first time it has been submitted for market approval in China. Radio ligand therapy, represented by Lu [177Lu], is a focus area for Novartis AG Sponsored ADR's heavy investment. In addition to Pluvicto, Novartis AG Sponsored ADR has another nuclear medicine, Lutathera, which has also been approved for marketing for the treatment of somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors in adults and later approved for patients aged 12 and above. Lutathera had sales of 6.05 billion US dollars in 2023, and sales for the first three quarters of 2024 were 5.34 billion US dollars. Screenshot source: CDE official website