FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Abbvie/J&J Combination Therapy Gets FDA Nod

Feb. 5, 2019

The FDA approved Abbvie and Johnson & Johnson’s Imbruvia (ibrutinib) and Gazyva (obinutuzumab) combination therapy.

The combination therapy is indicated for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Imbruvica was previously approved as a single agent or in combination with bendamustine and rituximab for CLL/SLL patients.

The FDA based the results on a Phase 3 trial that showed significantly improved progression-free survival compared to chlorambucil plus obinutuzumab. The agency also updated Imbruvica’s labeling to include additional long-term efficacy follow-up supporting its use as a single agent.

View today's stories