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.

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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
FDA (1) not 17p deletion Chronic Lymphocytic Leukemia Ibrutinib