Pralsetinib is under clinical development by F. Hoffmann-La Roche and currently in Phase II for Pancreatic Cancer. According to GlobalData, Phase II drugs for Pancreatic Cancer have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Pralsetinib’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.

Pralsetinib overview

Pralsetinib (Gavreto) is an anticancer agent. It is formulated as hard gelatin capsules for oral route of administration. Gavreto is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). Gavreto is also indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy and RETfusion-positive medullary thyroid cancer (MTC) who require systemic therapy and who are radioactive iodine-refractory. Gavreto is indicated for the treatment of advanced or metastatic RET fusion-positive thyroid cancer (TC) who requires systemic therapy and radioactive iodine-refractory (if radioactive iodine treatment is appropriate) in adult and pediatric patients 12 years of age and older and RET-mutant medullary thyroid cancer (MTC) who requires systemic therapy, and adult and pediatric patients 12 years of age and older.
Pralsetinib (BLU-667) is under development for the treatment of medullary thyroid cancer and other advanced solid tumors that harbor a RET alteration, pancreatic, bile duct cancer (cholangiocarcinoma), colon, mesenchymal, salivary gland cancer and thymoma. It is administered orally in the form of capsule. BLU-667 acts by targeting RET receptor tyrosine kinase.

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 Pralsetinib’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 7 February 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.