Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer
Expanded Access Program for Pirtobrutinib for Previously Treated B-Cell Cancers
This is an expanded access program for eligible participants with a previously treated B-cell cancer who are ineligible for an ongoing pirtobrutinib clinical trial. The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
Leukemia, Lymphocytic, Chronic, B-Cell
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Inclusion Criteria: - Have been diagnosed with: - CLL or SLL and have received treatment with the following five classes of therapy: Chemotherapy, anti-cluster of differentiation (anti-cd) 20 antibody, covalent Bruton's tyrosine kinase (BTK) inhibitor, B-cell lymphoma-2 (BCL-2) inhibitor, and phosphatidylinositol 3-kinase (PI3K) inhibitor - MCL that has been previously treated with a covalent BTK inhibitor - Richter's Transformation (RT) with previous Richter's directed-therapy - Waldenstrom macroglobulinemia (WM), previously treated with chemotherapy, anti-CD20 antibody and a covalent BTK inhibitor - Are not eligible for an ongoing pirtobrutinib clinical trial Exclusion Criteria: - Inadequate organ function - Significant cardiovascular disease - History of allogenic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified Tcell (CAR-T) therapy within 60 days - Tested positive for human immunodeficiency syndrome (HIV) or known active hepatitis B or C virus or cytomegalovirus (CMV) infection - Active, uncontrolled autoimmune cytopenia - Clinically significant active malabsorption syndrome - Participants requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist
18 Years - N/A
Contact Lilly at 1-800-LillyRx (1-800-545-5979), 1-800-LillyRx (1-800-545-5979), [email protected]
Loxo Oncology, Inc.
Contact Lilly at 1-800-LillyRx (1-800-545-5979), Study Director, Eli Lilly and Company
January 15, 2023