FDA Grants Accelerated Approval to Eli Lilly’s Jaypirca for Treatment of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Eli Lilly and Company has received accelerated approval for Jaypirca (pirtobrutinib) by the U.S. Food and Drug Administration for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
This application was granted priority review and orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.
