Lilly’s Non-Covalent Jaypirca Meets Primary Endpoint in Phase 3 Trial vs AbbVie’s Imbruvica; AbbVie Seeks FDA Approval for VENCLEXTA-Acalabrutinib Combo

Eli Lilly's Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible) BTK inhibitor, has met its primary endpoint in a head-to-head Phase 3 trial against AbbVie's Imbruvica (ibrutinib) for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This trial result indicates Jaypirca's superior efficacy compared to AbbVie's treatment. Meanwhile, AbbVie has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a combination therapy of VENCLEXTA® (venetoclax) and Acalabrutinib for previously untreated CLL patients. The AbbVie submission reflects ongoing efforts to expand treatment options for CLL, although Lilly's Jaypirca currently demonstrates a clinical advantage based on the recent Phase 3 data.