Regulatory approval

Published by the Food and Drug Administration. Approved

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

This is written in the approval document.

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.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	17p deletion	Chronic Lymphocytic Leukemia	Ibrutinib

Contributions

Date	Contributor	Description
2025-10-03	Van Allen lab	On 2018-02-16 the FDA granted approval to ibrutinib for the treatment of adult patients with chronic lymphocytic leukemia (CLL) / Small lymphocytic lymphoma (SLL) with 17p deletion.
2018-02-16	Food and Drug Administration	Indication received traditional approval.