Obinutuzumab is under clinical development by F. Hoffmann-La Roche and currently in Phase III for Lupus Nephritis. According to GlobalData, Phase III drugs for Lupus Nephritis have a 33% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Obinutuzumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Obinutuzumab overview

Obinutuzumab (Gazyva, Gazyvaro, Gaziva) is a glycoengineered, fully humanized IgG1 monoclonal antibody with anti-neoplastic activity. It is formulated as injectable concentrate solution for intravenous route of administration. Obinutuzumab is indicated for the treatment of chronic lymphocytic leukemia (CLL) and end-stage kidney disease (end-stage renal disease or ESRD), in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia (CLL), in combination with bendamustine followed by Gazyva monotherapy, is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen, and in combination with bendamustine chemotherapy followed by Gazyvaro maintenance in people with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with MabThera (rituximab) or a MabThera-containing regimen.

Obinutuzumab (a rituximab biobetter) is under development for the treatment of systemic lupus erythematosus, hairy cell leukemia, lupus nephritis, graft versus host disease (GVHD), Waldenstrom macroglobulinemia, membranous nephropathy, non-Hodgkin lymphoma, diffuse large B-cell lymphoma, nodal, metastatic hormone refractory (castration resistant, androgen-independent) prostate cancer, metastatic melanoma and idiopathic nephrotic syndrome. It is also under development for follicular lymphoma in Japan. It is administered through intralesional and intravenous route. It is a new molecular entity (NME).

It was also under development for the treatment of end stage kidney disease, non-Hodgkin lymphoma, cutaneous t-cell lymphoma, relapsed and refractory chronic lymphocytic leukemia marginal zone lymphoma (MZL), follicular lymphoma (FL), extranodal and splenic marginal zone lymphoma and mantle cell lymphoma.

F. Hoffmann-La Roche overview

F. Hoffmann-La Roche (Roche) is a biotechnology company that develops drugs and diagnostics to treat major diseases. It provides medicines for the treatment of cancer, other auto-immune diseases, central nervous system disorders, ophthalmological disorders, infectious diseases, and respiratory diseases. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Roche conducts research to identify novel methods to prevent, diagnose, and treat diseases. The company offers its products and services to hospitals, healthcare professionals, commercial laboratories, researchers, and pharmacists. Roche is headquartered in Basel, Switzerland.

For a complete picture of Obinutuzumab’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.