Entrectinib is under clinical development by F. Hoffmann-La Roche and currently in Phase II for Metastatic Uveal Melanoma. According to GlobalData, Phase II drugs for Metastatic Uveal Melanoma have a 21% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Entrectinib’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.

Entrectinib overview

Entrectinib (Rozlytrek) belongs to phenylpiperazines class of compounds, acts as an anti-neoplastic agent. It is formulated as hard gelatin capsules and pellets 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, 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. It was also under development for the treatment of metastatic melanoma.

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. Roche is headquartered in Basel, Switzerland.

For a complete picture of Entrectinib’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 10 June 2024

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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.