Novartis' (NVS.US) lutetium [177Lu] Lutetium Dotatate (Lu-DOTATATE) NDA Accepted by CDE
1min read Novartis' (NVS.US) lutetium [177Lu] lutetide, Pluvicto, has been accepted for review by the CDE on November 13. The drug was previously included in the priority review by the CDE and is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult patients who have received androgen receptor pathway inhibitors and taxane chemotherapy. It is the first targeted radioactive ligand therapy approved by the FDA for patients with castration-resistant prostate cancer, and this is its first domestic submission for market approval.Radiopharmaceuticals, represented by radioactive ligand therapy, is a field that Novartis has heavily invested in. In addition to Pluvicto, Novartis has another nuclear drug, Lutathera, which has been approved for the treatment of adult patients with somatostatin receptor-positive (SSTR+) gastrointestinal and pancreatic neuroendocrine tumors. It was later approved for use in children aged 12 years and above. Lutathera's 2023 sales reached US$605 million, and its sales in the first three quarters of 2024 were US$534 million.[Image src="//e.thsi.cn/img/b295118f2a49e575" id="692fc21b8f4885f4c251201b9d7153e6" data-type=""]