Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration (FDA) granted approval to ibrutinib for the treatment of adult patients with chronic lymphocytic leukemia (CLL) / Small lymphocytic lymphoma (SLL) with a 17p deletion.

This is written in the approval document as:

IMBRUVICA is a kinase inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) / Small lymphocytic lymphoma (SLL) with 17p deletion.

Citation

Pharmacyclics LLC. Itovebi (inavolisib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205552s043,210563s019,217003s004lbl.pdf. Revised December 2024. Accessed October 3, 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	17p deletion	Chronic Lymphocytic Leukemia	Ibrutinib