Entrectinib is under clinical development by F. Hoffmann-La Roche and currently in the Phase I, Phase II and Phase III 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 Entrectinib’s likelihood of approval (LoA) and phase transition for Fibrosarcoma took place on 06 Sep 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

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

Entrectinib overview

Entrectinib (Rozlytrek) belongs to phenylpiperazines class of compounds, acts as an anti-neoplastic agent. It is formulated as hard gelatin capsules for oral route of administration. Rozlytrek is indicated for the treatment of adult and pediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours including pancreatic cancer, thyroid cancer, salivary gland cancer, breast cancer, colorectal cancer, and non small cell lung cancer, and also indicated for the treatment of TrkA-positive, TrkB-positive, TrkC-positive ROS1-positive or ALK-positive non-small cell lung cancer.

Entrectinib (RXDX-101) is under development for the treatment of solid tumors including non-small cell lung cancer (NSCLC), metastatic colorectal cancer, anaplastic large cell lymphoma, leptomeningeal disease, metastatic pancreatic cancer, salivary gland cancer, brain tumor, astrocytoma, synovial sarcoma, fibrosarcoma, triple negative, HER-2 positive, ER or PR positive breast cancer, head and neck cancer, ovarian cancer, neuroblastoma, central nervous system (CNS) tumor, cholangiocarcinoma, papillary thyroid cancer, renal cell carcinoma, metastatic melanoma, mammary analog secretory carcinoma, acute myeloid leukemia, squamous non-small cell lung cancer and stages I-III non-small cell lung cancer with ALK, ROS1, NTRK, or BRAF v600E molecular alterations. The drug candidate is administered orally. The drug candidate is a selective tyrosine kinase inhibitor of the TrkA, TrkB and TrkC, ROS1 and ALK proteins. It is developed based on Rx/Dx technology platform.

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, commercial laboratories, healthcare professionals, researchers, and pharmacists. Together with its subsidiaries and partners, the company has operations in various countries. Roche is headquartered in Basel, Switzerland.

Quick View Entrectinib LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Entrectinib
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
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.