Trastuzumab is under clinical development by F. Hoffmann-La Roche and currently in Phase III for Ductal Carcinoma In Situ. According to GlobalData, Phase III drugs for Ductal Carcinoma In Situ have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Trastuzumab’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.
Trastuzumab overview
Trastuzumab (Herceptin, Herclon, Herceptin SC) is a humanized IgG1 kappa monoclonal antibody. It is formulated as freeze-dried powder for solution for intravenous administration and solution for subcutaneous, intravenous route of administration. Herceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer, in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable, in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease, adult patients with HER2 positive early breast cancer, in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture containing the antibiotic gentamicin. The drug candidate is based on enhanze technology which is a drug delivery platform designed to increase the absorption and dispersion of biologics.
The drug candidate is under development for the treatment of non-squamous non-small cell lung cancer. It is administered through intravenous route. It was also investigated for intravenous urothelial cancer and adjuvant HER2 positive breast cancer, ductal carcinoma in situ and pancreatic cancer.
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. Together with its subsidiaries and partners, the company has operations in various countries. Roche is headquartered in Basel, Switzerland.
For a complete picture of Trastuzumab’s drug-specific PTSR and LoA scores, buy the report here.
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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.
