相关临床试验
30
13 进行中
药物批准
12
批准总数
监管机构
3
监管机构数
成立时间
2002
进行中（未招募）
13
43.3%
Approved For Marketing
1
3.3%
已完成
6
20.0%
No Longer Available
1
3.3%
招募中
2
6.7%
终止
6
20.0%
撤回
1
3.3%
- The FDA approved Curium's Bexlutry (lutetium Lu 177 dotatate), the first generic radioligand therapy, for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. - Bexlutry was cleared via the 505(b)(2) pathway as a radioligand equivalent to Novartis' Lutathera, relying on published evidence and bridging data rather than a new pivotal trial. - The approval follows Curium's June 2026 patent litigation victory over Novartis subsidiary Advanced Accelerator Applications, clearing the path for immediate launch. - Curium has agreed to merge with Lantheus in a transaction valued at up to approximately USD 8 billion, potentially expanding radiopharmaceutical capabilities.
- The Delaware U.S. District Court ruled that all relevant patent claims asserted by Novartis/AAA against Curium's Lutetium Lu 177 dotatate are invalid and not infringed, representing a complete victory for Curium. - The decision enables Curium to launch its targeted radioligand therapy in the U.S. for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. - Curium brings over 100 years of nuclear medicine experience and a 30-year commitment to the NET community, with existing diagnostic products and a late-stage pipeline in prostate cancer. - The company aims to build a durable theranostics platform pairing diagnostic leadership with targeted radioligand therapies to serve patients reliably at scale.
- Radionuclide therapies are emerging as promising options for treating metastatic castration-resistant prostate cancer (mCRPC), especially after resistance to standard treatments. - Lutetium-177 PSMA-617 (Lu-PSMA-617) has demonstrated overall survival benefits in mCRPC patients, leading to FDA and EMA approvals for PSMA-positive cases. - Ongoing clinical trials are exploring Lu-PSMA-617 in earlier stages of prostate cancer and in combination with other therapies like androgen deprivation and immunotherapy. - Targeted alpha therapy using Actinium-225 labeled PSMA ligands shows potential for improved outcomes, particularly in patients who do not respond to Lutetium-177 based treatments.
