Imbruvica Gains New Lymphoma Indication

Imbruvica Gains New Lymphoma Indication
Imbruvica Gains New Lymphoma Indication

The Food and Drug Administration (FDA) has approved Imbruvica (ibrutinib; Pharmacyclics and Janssen Biotech) for patients with Waldenström's macroglobulinemia (WM).

Imbruvica is a Bruton's tyrosine kinase inhibitor currently approved for mantle cell lymphoma (MCL) in patients who have received at least one prior therapy, chronic lymphocytic leukemia (CLL) in patients who have received at least one prior therapy, and CLL in patients with 17p deletion.

RELATED: Expanded Use of Imbruvica Approved

The FDA's expanded approval was based on data from a clinical study (n=63) of previously treated patients with WM. Patients received 420mg daily until disease progression or until side effects became intolerable. Study data showed 62% of patients had an overall response rate.

Imbruvica was granted breakthrough therapy designation, priority review, and orphan product designation for WM.

For more information call (877) 877-3536 or visit Imbruvica.com.

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