Leukemia drug Imbruvica (ibrutinib) approved for CLL

Leukemia drug Imbruvica (ibrutinib) approved for CLL

12/2/2014

The US FDA approved the targeted drug ibrutinib (Imbruvica) as 2nd-line treatment for patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Ibrutinib was first approved last November as a treatment for mantle cell lymphoma in patients who failed at least one prior therapy. It inhibits Bruton's tyrosine kinase, a key component of the intracellular signalling cascade that drives malignant cell proliferation.

The CLL approval was based on a 48-patient, uncontrolled study in which the drug produced an overall response rate of nearly 58%, the agency said, with response durations ranging from 5.6 to 24.2 months. Patients in the trial had received an average of four prior therapies.

Whether the drug improves survival or disease-related symptoms relative to other therapies has not been established, the FDA noted.

The FDA approved the new indication under its accelerated approval process, which allows the agency to give an OK using endpoints that don't directly indicate clinical benefit. Ordinarily, these approvals come with requirements for follow-up studies designed to prove clinical benefit, but the FDA did not indicate what it would require from ibrutinib's manufacturer, Pharmacyclics.

Common side effects seen in the CLL study included thrombocytopenia, diarrhea, bruising, neutropenia, anemia, upper respiratory infections, fatigue, musculoskeletal pain, rash, fever, constipation, peripheral edema, arthralgia, stomatitis, nausea, sinusitis, and dizziness, the FDA said.

 

Source: MedPage Today: http://www.medpagetoday.com/HematologyOncology/Leukemia/44274