FDA Expands Eli Lilly's Blood Cancer Drug Label in First-Line Setting

What happened: The FDA expanded the label of Eli Lilly's oral drug Jaypirca (pirtobrutinib) to include first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma in adults without a known 17p deletion. Key numbers: Phase III BRUIN CLL-313 showed an 80% reduction in risk of Why it matters: The approval adds a first-line use for a drug Lilly describes as the first and only FDA-approved non-covalent BTK inhibitor, letting it compete with Brukinsa, Calquence and Imbruvica in the CLL/SLL market. Sales remain small relative to Lilly's obesity and diabetes portfolio.

The FDA expanded the label of Eli Lilly's oral drug Jaypirca (pirtobrutinib) to include first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma in adults without a known 17p deletion.

The approval adds a first-line use for a drug Lilly describes as the first and only FDA-approved non-covalent BTK inhibitor, letting it compete with Brukinsa, Calquence and Imbruvica in the CLL/SLL market. Sales remain small relative to Lilly's obesity and diabetes portfolio.