Polatuzumab vedotin is under clinical development by Genentech USA and currently in the Phase I, Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Polatuzumab vedotin’s likelihood of approval (LoA) and phase transition for T-Cell Lymphomas took place on 03 Nov 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Polatuzumab vedotin Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Polatuzumab vedotin overview

Polatuzumab vedotin (Polivy / Ropolivy) is a monoclonal antibody, acts as an anti-neoplastic agent. It is produced by mammalian Chinese hamster ovary (CHO) cells. It is formulated as lyophilized  powder for solution for intravenous route of administration. It is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma that has progressed or returned after at least two prior therapies. Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

Polatuzumab vedotin (RG-7596) is under development for the treatment of hematologic malignancies including Burkitt lymphoma, non-Hodgkin's lymphoma, primary mediastinal B-cell lymphoma, primary cutaneous DLBCL, High-grade B-cell lymphoma, T-cell/histiocyte-rich large B-cell lymphoma, Non-Hodgkin lymphoma, Hodgkin lymphoma (B-Cell Hodgkin Lymphoma),thymic carcinoma and T-Cell lymphomas, T-cell/histiocyte-rich large-B-cell lymphoma, epstein-barr virus (EBV) + DLBCL, NOS, ALK+ large B-cell lymphoma, relapsed or refractory follicular lymphoma and previously untreated relapsed or refractory diffuse large B-cell lymphoma. The drug candidate is administered intravenously. It is an anti-CD79b antibody-drug conjugate (ADC) composed of the cytotoxic agent monomethyl auristatin E (MMAE) linked to an anti-CD79b monoclonal antibody targeting MMAE to B-cells through CD79b. It was also under development for mantle cell lymphoma and chronic lymphocytic leukemia.

Genentech USA overview

Genentech USA (Genentech), a subsidiary of F. Hoffmann-La Roche Ltd, is a biotechnology company that discovers, develops, manufactures and commercializes medicines to address serious medical needs. It offers drugs in various therapeutic areas including oncology, immunology, ophthalmology, metabolism, neurology, and infectious disease, among others. Its pipeline products include Emicizumab (RG6013, ACE910), a bispecific monoclonal antibody used to replace the function of protein in the blood clotting process; and Entrectinib (RXDX-101, RG6268), a CNS-active tyrosine-kinase inhibitor intended for the treatment of non-small cell lung cancer; among others. The company has partnership with BioLineRx, Charles River Laboratories International, Amunix, among others. Genentech is headquartered in South San Francisco, California, the US.

Quick View Polatuzumab vedotin LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Polatuzumab vedotin
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.