The U.S. Food and Drug Administration on Wednesday granted traditional approval to Eli Lilly and Company's Jaypirca for pre-treated adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The agency approved the drug for patients who were previously treated with a covalent BTK inhibitor, a class of drugs that permanently bind to and block the Bruton's tyrosine kinase (BTK) protein, which is crucial for the survival of certain B-cell cancers like chronic lymphocytic leukemia.

In December 2023, the FDA had granted accelerated approval to Jaypirca for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy. Accelerated approval is a conditional approval that requires the drug maker to conduct confirmatory studies after the drug is on the market to verify the clinical benefit. 

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