Ohio State University Developed Drug Receives FDA Approval for Treatment of CLL and SLL

Nov 26, 2019 | Acalabrutinib, Chronic Lymphocytic Leukemia, Leading Sites, Ohio State University, Site Success, Site Watch, Small Lymphocytic Lymphoma (SLL)

Ohio State University Developed Drug Receives FDA Approval for Treatment of CLL and SLL

A drug developed at Ohio State University Comprehensive Cancer Center—Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC-James) in collaboration with biopharma venture partner Acerta Pharma benefited from FDA approval as a first-line therapy in chronic lymphocytic leukemia (CLL) and small cell lymphoma (SCL).

The Drug

The FDA approval part of the FDA’s Project Orbis, makes acalabrutinib (Calquence®) is a second-generation Burton tyrosine kinase (BTK) inhibitor, a newer class of drugs shown to improve the survival of patients with mantle cell lymphoma in addition to CLL and SML.

How it Works

By permanently binding BTK, which is part of a chain of proteins that relays growth signals from the surface of the cancer cell to genes in the cell nucleus, it enables cancer cells to survive and grow. By blocking BTK, the drug halts the flow of these growth signals, and the cancer cells die. Unlike generation one BTK inhibitor (e.g. ibrutinib), acalabrutinib more selectively blocks the BTK pathway, without disrupting other key molecular pathways important for preserving platelet and immune function, thereby preventing/minimizing certain side effects associated with cancer treatment.

OSUCCC—James Clinical Investigators

OSUCCC—James researchers, led by John C. Byrd, MD, Distinguished University Professor and the D. Warren Brown Designated Chair in Leukemia Research at the OSUCCC—James, performed foundational basic-science research to initial Phase I clinical trial work and numerous Phase II and Phase III trials that led to the FDA approval.

A Collaborative Affair

Drug discovery and development represents a group, collaborative affair and the effort to develop acalabrutinib was no exception. Other organizations involved included the Ohio State University College of Veterinary Medicine and the Comparative and Translational Oncology Program, a research collaboration that integrates nearly 40 scientific investigators from Ohio State’s colleges of medicine, pharmacy, nursing and veterinary medicine, along with researchers from Nationwide Children’s Hospital, to investigate cancers that occur in both humans and animals. William Kisseberth, DVM, directed the studies of acalabrutinib in dogs with lymphoma.


Developing drugs isn’t cheap, and funds are required. Thankfully, some wonderful government foundations and other organizations pitched in to make this happen in addition to Ohio State University; they included:

Lead Research/Investigator

John C. Byrd 


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