Trastuzumab emtansine is under clinical development by Genentech USA and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Trastuzumab emtansine’s likelihood of approval (LoA) and phase transition for Triple-Negative Breast Cancer (TNBC) took place on 13 Jan 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Trastuzumab emtansine Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Trastuzumab emtansine overview

Trastuzumab Emtansine (Kadcyla) is an antibody drug conjugate (ADC) belongs to antineoplastic agent. It is formulated as lyophilized powder for concentrate for solution for intravenous route of administration. Kadcyla is indicated in treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination, and is indicated for the adjuvant treatment of patients with HER2-positive early breast cancer who have  residual invasive disease after neoadjuvant taxane and trastuzuma-based treatment.

Trastuzumab emtansine is also under development for the treatment of epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, endometrioid carcinoma, HER2-positive metastatic breast cancer (adjuvant and third-line therapy), triple negative breast cancer, lung cancer, colorectal cancer, HER2-positive advanced extramammary Paget's disease and salivary gland cancer. It is administered through subcutaneous and intravenous routes. It was also under development for the treatment of pretreated HER2 positive metastatic breast cancer, non-small cell lung cancer, HER2 expressing pancreatic cancer, refractory multiple myeloma, advanced refractory lymphoma, bladder cancer, cholangiocellular carcinoma, urinary tract cancer and metastatic colorectal cancer.

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. Its 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.

Quick View Trastuzumab emtansine LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Trastuzumab emtansine
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: Genentech USA
  • Originator: Genentech USA
Highest Development Stage
  • Marketed


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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.