Sacituzumab govitecan by Gilead Sciences for Muscle Invasive Bladder Cancer (MIBC): Likelihood of Approval
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Sacituzumab govitecan is under clinical development by Gilead Sciences and currently in Phase II for Muscle Invasive Bladder Cancer (MIBC). According to GlobalData, Phase II drugs for Muscle Invasive Bladder Cancer (MIBC) does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Sacituzumab govitecan LoA Report. 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.
Sacituzumab govitecan overview
Sacituzumab govitecan (Trodelvy) is a conjugated humanized monoclonal antibody with potential antineoplastic activity. It is formulated as lyophilized powder for solution for intravenous route of administration. Trodelvy is indicated for the treatment of adult patients with unresectable or locally advanced metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. Trodelvy is indicated for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Sacituzumab govitecan (IMMU-132) is under development for the treatment of advanced or metastatic urothelial carcinoma, papillary thyroid cancer, hepatocellular carcinoma, refractory or relapsed advanced including epithelial ovarian cancer, colorectal, gastric, hepatocellular, bladder cancer, head and neck squamous cell carcinoma, metastatic hormone-refractory prostate, small-cell and metastatic non-small-cell lung cancer, pancreatic ductal adenocarcinoma, HER2 negative breast cancer, esophageal, renal cell cancer, metastatic transitional (Urothelial) tract cancer, endometrial cancer, cervical cancer, esophageal squamous cell carcinoma (escc), adenocarcinoma of the gastroesophageal junction, biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, lung adenocarcinoma, glioblastoma multiforme malignant glioma, muscle invasive bladder cancer and metastatic breast cancer with brain metastasis. It is administered as an intravenous route. IMMU-132 is a camptothecin-based ADC where the antibody, RS7 is attached to SN38. IMMU-132 targets cells expressing TROP-2. It was also under development for follicular thyroid cancer and adenocarcinoma.
Gilead Sciences overview
Gilead Sciences (Gilead) is a research-based biopharmaceutical company. It is engaged in the discovery, development and commercialization of medicines for the treatment of cardiovascular, hematological and respiratory diseases, inflammation, liver diseases, cancer, and human immunodeficiency virus (HIV) infection. The company sells its products through subsidiaries and distributors in Europe, the Americas, Asia-Pacific, the Middle East and Africa. It has manufacturing facilities in Edmonton, Alberta, Canada; Foster City, San Dimas, Oceanside, California; and Cork, Ireland among others. The company has partnerships with universities, medical research institutions and global pharmaceutical leaders to develop new drugs. Gilead is headquartered in Foster City, California, the US.
For a complete picture of Sacituzumab govitecan’s drug-specific PTSR and LoA scores, buy the report here.
This content was updated on 2 September 2023
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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.