{"id":68670,"date":"2026-06-22T20:12:20","date_gmt":"2026-06-22T12:12:20","guid":{"rendered":"https:\/\/flcube.com\/?p=68670"},"modified":"2026-06-22T20:12:21","modified_gmt":"2026-06-22T12:12:21","slug":"roches-lunsumio-polatuzumab-combination-accepted-for-fda-review-in-relapsed-refractory-large-b-cell-lymphoma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=68670","title":{"rendered":"Roche’s Lunsumio-Polatuzumab Combination Accepted for FDA Review in Relapsed\/Refractory Large B-Cell Lymphoma"},"content":{"rendered":"\n

Roche Holding AG<\/strong> (SWX: ROP<\/a>; OTCMKTS: RHHBY<\/a>) announced that the U.S. Food and Drug Administration (FDA)<\/strong> has accepted for review a new indication filing for Lunsumio<\/strong> (mosunetuzumab) in combination with polatuzumab vedotin<\/strong> for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL)<\/strong>, including diffuse large B-cell lymphoma (DLBCL)<\/strong>, who have received at least one prior line of systemic therapy<\/strong>. The FDA is expected to issue its decision by February 9, 2027<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Parameter<\/th>Detail<\/th><\/tr><\/thead>
Regulatory Agency<\/strong><\/td>FDA (United States)<\/td><\/tr>
Application Status<\/strong><\/td>Accepted for review<\/td><\/tr>
Product Combination<\/strong><\/td>Lunsumio (mosunetuzumab) + polatuzumab vedotin<\/td><\/tr>
Target Indication<\/strong><\/td>Relapsed\/refractory LBCL\/DLBCL (\u22651 prior therapy)<\/td><\/tr>
PDUFA Date<\/strong><\/td>February 9, 2027<\/td><\/tr>
Current Approval<\/strong><\/td>Follicular lymphoma (\u22653 prior therapies) as monotherapy<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Product Profile & Mechanism of Action<\/h2>\n\n\n\n