FDA expands Imbruvica label to include survival data

Janssen Biotech and AbbVie company Pharmacyclics are jointly developing and commercializing Imbruvica, which blocks a specific protein called Bruton’s tyrosine kinase.

The Imbruvica labeling now includes OS results from the randomized, multicenter, open-label, phase 3 Resonate-2 trial that evaluated previously-untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients.

Data from this trial helped support the recent FDA approval of Imbruvica as first-line treatment for CLL patients.

Imbruvica showed a statistically significant 56% reduction in the risk of death after a median follow-up of 28.1 months. The analysis included 41% of patients in the chlorambucil arm who crossed over to receive the therapy after progressing.

The labeling has also been updated with efficacy and safety data from the randomized, multicenter, double-blind, Phase 3 Helios trial that assessed Imbruvica in combination with bendamustine and rituximab (BR) vs. placebo plus BR in relapsed/refractory patients with CLL/SLL.

Imbruvica plus BR demonstrated an 80% reduction in the risk of progression or death versus placebo and BR.

Additionally, the FDA has approved the use of Imbruvica for the treatment of patients with SLL with or without the deletion of chromosome 17p (del 17p) based on the November 2015 supplemental New Drug Application (sNDA) review.

Janssen Research & Development global oncology head Peter Lebowitz said: "The clinical development plan for Imbruvica is very robust and includes many Phase 2 and 3 clinical trials across various indications and combinations.

"In partnership with Pharmacyclics, an AbbVie company, we continue to explore the clinical utility of Imbruvica and potential benefit it offers to patients with CLL/SLL and other hematologic malignancies."

Image: AbbVie US Headquarters. Photo: courtesy of AbbVie Inc.