Expanded Indication Approved for Chronic Lymphocytic Leukemia Treatment

The FDA has approved Janssen Biotech's ibrutinib capsules for treatment-naïve patients with chronic lymphocytic leukemia.

The FDA has approved Janssen Biotech’s ibrutinib (Ibruvica) capsules for treatment-naïve patients with chronic lymphocytic leukemia (CLL).

The FDA based its decision on results from the phase 3 RESONATE-2 study, which showed that Imbruvica could significantly extend progress-free survival and improve response rate compared with chlorambucil among patients aged 65 years and older.

"People living with CLL who have not been previously treated now have an option that significantly improved progression-free survival when compared to the oral chemotherapy used in the RESONATE-2 trial," said Jan Burger, RESONATE-2 study lead investigator, in a press release. "The results seen in the RESONATE-2 clinical trial are truly compelling and make this medicine an attractive first-line treatment option for clinicians in the hematology space."

With this approval, Imbruvica can be used in all lines of CLL therapy. Back in 2014, the treatment was approved for patients who had received at least 1 prior therapy. That same summer, it was approved for CLL patients with del 17p, which is a mutation associated with poor treatment outcomes.

The most common adverse effects associated with Imbruvica include diarrhea, muscle and bone pain, tiredness, and nausea.