POLIVY

批准信原文要点

This Prior Approval sBLA provides for updates to the product labeling to include the addition of “Infusion Site Extravasation Injury” information to subsections 2.4, 5.8, Section 6 Adverse Reactions, and Section 17 Patient Counseling Information of the USPI.

批准信原文要点

This Prior Approval supplemental biologics license application provides for the following indication: POLIVY in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater.

批准信原文要点

This Prior Approval sBLA provides for: • Introduction of a new polatuzumab vedotin-piiq 30 mg/vial lyophilized drug product configuration manufactured at the Roche Parenteral Production Facility, Kaiseraugst, Switzerland (PKau), • Transfer of release and stability analytical procedures to PKau, • Addition of identity release testing by Peptide Map, • Addition of moisture release testing by Near-Infrared Spectrometry, as an alternative method to moisture determination by the Karl Fischer method, • Addition of Roche Diagnostics, GmbH, Mannheim, Germany as a labeling and secondary packaging site, • Extension of the storage duration after dilution in 0.9% Sodium Chloride from 24 hours to 36 hours at 2°C to 8°C