Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that 17p deletion status confers therapeutic sensitivity to Ibrutinib in patients with Chronic Lymphocytic Leukemia.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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. Pharmacyclics LLC. Itovebi (inavolisib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210563-orig2lbl.pdf. Revised February 2018. Accessed October 6, 2026.

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.