Fenebrutinib is under clinical development by Genentech USA and currently in Phase III for Primary Progressive Multiple Sclerosis (PPMS). According to GlobalData, Phase III drugs for Primary Progressive Multiple Sclerosis (PPMS) have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Fenebrutinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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.

Fenebrutinib overview

Fenebrutinib (GDC-0853, RG-7845) is under development for the treatment of B-cell non-Hodgkin's lymphoma, chronic lymphocytic leukemia, diffuse large B-cell lymphoma, mantle cell lymphoma, indolent lymphoma, follicular lymphoma, relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). It is administered orally. The drug candidate is a second generation Bruton's tyrosine kinase (BTK) inhibitor. It is a new molecular entity. It was also under development for the treatment of systemic lupus erythematosus, rheumatoid arthritis and chronic spontaneous urticaria.

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. The company’s 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.

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

This content was updated on 16 July 2024

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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.