Giredestrant is under clinical development by Genentech USA and currently in Phase III for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer). According to GlobalData, Phase III drugs for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer) have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Giredestrant’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.
GDC-9545 (RG-6171) is under development for the treatment of solid tumors, estrogen receptor positive and HER2 negative metastatic breast cancer, HER2-positive, estrogen receptor positive locally advanced or metastatic breast cancer, neoadjuvant ER positive breast cancer and endometrial cancer. The drug candidate is administered by the oral route. The drug candidate acts as a selective estrogen receptor degrader (SERD) by targeting the estrogen receptor (ER). The drug candidate is a new molecular entity (NME).
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 Giredestrant’s drug-specific PTSR and LoA scores, buy the report here.