[{"orgOrder":0,"company":"Advanced Accelerator Applications","sponsor":"Advanced Accelerator Applications","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"ITM expands PSMA-617 supply agreement for no-carrier-added Lutetium-177","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Advanced Accelerator Applications","sponsor":"ABX Advanced Biochemical Compounds","pharmaFlowCategory":"D","amount":"$172.0 million","upfrontCash":"$12.0 million","newsHeadline":"Otsuka Subsidiary to Receive Payment and Royalties from Approval in U.S. of - Out-licensed by ABX in Germany, an indirectly-owned subsidiary of Otsuka Pharmaceutical","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Advanced Accelerator Applications","sponsor":"Novartis Pharmaceuticals Corporation","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Pluvicto\u2122 Approved by FDA as First Targeted Radioligand Therapy for Treatment of Progressive, PSMA-positive Metastatic Castration-Resistant Prostate Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Advanced Accelerator Applications","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MHRA Grants Marketing Authorisation for Novartis\u2019 Radioligand Therapy Pluvicto\u00ae (Lutetium (\u00b9\u2077\u2077lu) Vipivotide Tetraxetan) in Advanced Prostate Cancer in Great Britain","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Large molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals by Advanced Accelerator Applications
Pluvicto® (lutetium (177Lu) vipivotide tetraxetan) is indicated for the treatment of adult patients with PSMA-positive mCRPC who have been treated with AR pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.
Advanced Accelerator Applications (AAA) and Endocyte, Inc., both Novartis companies, successfully completed full-scale development of Pluvicto and also received Breakthrough Therapy designation from the U.S. FDA last year.
FDA approval was based on VISION trial, where patients with pre-treated PSMA-positive mCRPC who received Pluvicto plus standard of care had a statistically significant reduction in risk of death1; both alternate primary endpoints of OS and radiographic PFS were met.
ITM will provide Endocyte with supply of n.c.a 177Lu for its investigational 177Lu-PSMA-617 radioligand therapy for patients with metastatic castration-resistant prostate cancer.