Type of information: Granting of a Fast Track status
Product name: polatuzumab vedotin
Compound: polatuzumab vedotin
Therapeutic area: Cancer - Oncology
Action mechanism: antibody drug conjugate. Polatuzumab vedotin (Anti-CD79b, DCDS4501A, RG7596) is an antibody drug conjugate (ADC) composed of a monoclonal antibody directed against CD79b, link to the cytotoxic, microtubule-disrupting agent, monomethyl auristatin E (MMAE). Polatuzumab vedotin is designed to selectively bind to CD79b on hematologic cells. It is being developed by Roche utilising Seattle Genetics ADC technology.
Company: Roche (Switzerland)
Disease: relapsed or refractory diffuse large B cell lymphoma (DLBCL)
- • On June 30, 2017, Roche announced that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation for polatuzumab vedotin in combination with MabThera® (rituximab) and bendamustine for the treatment of people with relapsed or refractory diffuse large B cell lymphoma (DLBCL). It is estimated that as many as 40% of patients with DLBCL relapse following initial treatment, at which time salvage therapy options are limited and survival is short.
- PRIME designation for polatuzumab vedotin is primarily based on results from the randomized phase II component of the GO29365 study. This global, phase Ib/II study is evaluating the safety, tolerability and activity of polatuzumab vedotin in combination with Mabthera®/Rituxan® (rituximab) or Gazyva®/Gazyvaro® (obinutuzumab) plus bendamustine in relapsed or refractory follicular or diffuse large B cell lymphoma. The primary objective was to evaluate responses to polatuzumab vedotin in combination with MabThera®/Rituxan® and bendamustine at the time of the primary response assessment (6 - 8 weeks after Cycle 6, Day 1 or the last dose of the study medication) and as defined by an independent review committee. The secondary efficacy objectives included best objective response (CR and OR) by investigator assessment with positron emission tomography and/or computed tomography scans and objective response (CR and PR) at the time of primary response assessment.
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