FDA approves new Imbruvica indication
AbbVie has received the Food and Drug Administration’s blessing for the use of Imbruvica (ibrutinib) in combination with obinutuzumab — brand name Gazyva — for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma, or CLL/SLL.
The latest FDA approval expands the use of Imbruvica, which already can be administered as a single agent or in combination with bendamustine and rituximab for adult CLL/SLL patients.
Imbruvica is a once-daily, first-in-class Bruton’s tyrosine kinase , or BTK, inhibitor that is administered orally and is jointly developed and commercialized by Pharmacyclics, an AbbVie company, and Janssen Biotech.
“This latest Imbruvica FDA approval gives the healthcare community the first chemotherapy-free, anti-CD20 combination to treat CLL and SLL patients who have not yet started therapy,” said Carol Moreno, consultant hematologist at the Hospital de la Santa Creu Sant Pau, Autonomous University of Barcelona in Barcelona, Spain, and lead investigator of the iLLUMINATE study. “Also, and importantly, this new treatment combination helps reduce the need for chemotherapy.”
“We are living in a time of significant advances in cancer treatment, particularly in blood cancers, and this latest Imbruvica FDA approval is an example,” Pharmacyclics head of clinical science Danelle James said. “I am proud that we can now give physicians and patients a new option to treat CLL and SLL without the need for chemotherapy.”
This is the first approval for a non-chemotherapy combination regimen for treatment-naïve patients with CLL/SLL, and marks the 10th FDA approval for Imbruvica since its U.S. launch in November 2013.
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