{"id":64019,"date":"2026-04-27T14:14:27","date_gmt":"2026-04-27T06:14:27","guid":{"rendered":"https:\/\/flcube.com\/?p=64019"},"modified":"2026-04-27T14:14:28","modified_gmt":"2026-04-27T06:14:28","slug":"novartis-withdraws-pluvicto-pre-chemotherapy-mcrpc-application-in-eu-following-chmp-objections-on-psmafore-control-arm-design","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=64019","title":{"rendered":"Novartis Withdraws Pluvicto Pre-Chemotherapy mCRPC Application in EU Following CHMP Objections on PSMAfore Control Arm Design"},"content":{"rendered":"\n

Novartis AG<\/strong> (NYSE: NVS<\/a>) announced the voluntary withdrawal of its Type II variation application<\/strong> to the European Medicines Agency (EMA)<\/strong> seeking approval of Pluvicto\u2122 (lutetium Lu 177 vipivotide tetraxetan)<\/strong> for prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)<\/strong> in patients prior to chemotherapy<\/strong>.<\/p>\n\n\n\n

The decision follows feedback from the EMA\u2019s Committee for Medicinal Products for Human Use (CHMP)<\/strong>, which indicated it would not support approval<\/strong> due to concerns over the control arm design<\/strong> in the pivotal PSMAfore Phase III trial<\/strong>. Novartis emphasized the withdrawal is unrelated to Pluvicto\u2019s quality, efficacy, or safety profile<\/strong> and does not impact existing approvals, ongoing trials, or other regulatory submissions globally.<\/p>\n\n\n\n

Regulatory Context & Trial Background<\/h2>\n\n\n\n
Element<\/th>Detail<\/th><\/tr><\/thead>
Drug<\/strong><\/td>Pluvicto\u2122 (\u00b9\u2077\u2077Lu-PSMA-617), a radioligand therapy<\/td><\/tr>
Indication Sought<\/strong><\/td>Pre-chemotherapy PSMA-positive mCRPC<\/td><\/tr>
Pivotal Study<\/strong><\/td>PSMAfore (NCT04689828) \u2013 randomized vs. second-generation androgen receptor pathway inhibitors (ARPIs)<\/strong><\/td><\/tr>
CHMP Concern<\/strong><\/td>Control arm lacked cross-over design<\/strong> or direct comparator to standard-of-care sequencing<\/td><\/tr>
Global Approvals<\/strong><\/td>Already approved<\/strong> for this indication in U.S., Japan, and China<\/strong> based on same data<\/td><\/tr>
Current EU Status<\/strong><\/td>Approved only for post-chemotherapy mCRPC<\/strong> (since 2023)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical & Commercial Implications<\/h2>\n\n\n\n