Pirtobrutinib is under clinical development by Eli Lilly and Co and currently in Phase II for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma). According to GlobalData, Phase II drugs for Waldenstrom Macroglobulinemia (Lymphoplasmacytic Lymphoma) have a 26% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Pirtobrutinib’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.

Pirtobrutinib overview

Pirtobrutinib (Jaypirca) is an anti-neoplastic agent. It is formulated as film coated tablets for oral route of administration. Jaypirca is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.

LOXO-305 (RXC-005) is under development for the treatment of chronic lymphocytic leukemia (CLL), small lymphocytic leukemia (SLL), non-Hodgkin lymphoma including mantle cell lymphoma, marginal zone lymphoma, Waldenstrom macroglobulinemia, B-cell cancers including R/R chronic lymphocytic leukemia (CLL) in patients resistant to ibrutinib, follicular lymphoma and diffuse large B-cell lymphoma. It is administered through oral and intravenous route. The drug candidate is a next generation reversible BTK inhibitor.It acts by targeting tyrosine protein kinase BTK. It is a new molecular entity (NME).

Eli Lilly and Co overview

Eli Lilly and Co (Lilly) is a healthcare company that is engaged in the discovery, development, and marketing of human healthcare products. The company offers medicines for cardiovascular conditions, diabetes, endocrinology, cancer, neurological problems, immune disorders, men’s health and musculoskeletal problems. The company distributes its pharmaceutical health products through independent wholesale distributors. Lilly conducts research and development activities to discover and deliver innovative medicines. It also promotes products through sales representatives and marketing agreements with other pharmaceutical companies. The company also offers its products in North America, South America, Europe, South Asia, the Middle East, Africa and North Asia-Pacific. Lilly is headquartered in Indianapolis, Indiana, the US.

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


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.