New York, NY –The U.S. Food and Drug Administration (FDA) announced it has approved the use of ibrutinib (IMBRUVICA) in combination with obinutuzumab (GAZYVA) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first chemotherapy-free, anti-CD20 combination regimen approved for CLL/SLL.
This approval expands the use of ibrutinib, which can already be administered as a single agent or in combination with bendamustine and rituximab for adult CLL/SLL patients. This approval also marks the tenth FDA approval for ibrutinib in six different disease areas since 2013.
“The approval of ibrutinib with obinutuzumab as a frontline combination therapy represents a major advancement for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma,” said Lymphoma Research Foundation Chief Executive Officer, Meghan Gutierrez. “Novel therapies and new methods of administration are important to ensuring that patients and their physicians, through shared decision making, are able to access the right treatments at the right time.”