FDA approves label update for Imbruvica (ibrutinib) in chronic lymphocytic leukemia/small lymphocytic lymphoma- Janssen
The FDA has approved an expansion to the U.S. Prescribing Information (PI) for Imbruvica (ibrutinib), from Janssen, based on data supporting its use in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The approved label now includes overall survival (OS) data from the Phase III RESONATE-2 (PCYC-1115) trial in treatment-naïve CLL/SLL patients 65 years or older. The updated label also contains clinical data from the Phase III HELIOS (CLL3001) trial investigating the use of Imbruvica in combination with bendamustine and rituximab (BR) versus placebo plus BR in patients with relapsed or refractory CLL/SLL.
Comment: Competitors include recently approved the anti-CD20 antibody Gazyva (obinutuzumab) from Roche, and the s PI3 kinase inhibitor Zydelig (idelalisib) from Gilead Sciences.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins