Johnson & Johnson (J&J) and AbbVie have secured approval from the US Food and Drug Administration (FDA) for Imbruvica plus obinutuzumab as non-chemotherapy combination regimen for treatment- naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
Imbruvica in combination with obinutuzumab is said to be the first approved non-chemotherapy combination regimen for treatment-naïve patients with CLL/SLL, which is the most common form of leukemia in adults.
Imbruvica, which is a Bruton’s tyrosine kinase (BTK) inhibitor, is jointly developed and commercialized by Janssen Biotech and AbbVie firm Pharmacyclics.
The approval was based on data from the phase 3 iLLUMINATE study. Imbruvica plus obinutuzumab demonstrated a significant improvement in Independent Review Committee (IRC)-evaluated progression-free survival compared with chlorambucil plus obinutuzumab with a 77% reduction in risk of progression or death at a median follow-up of 31 months.
Janssen Research & Development clinical development and global medical affairs vice president Dr Craig Tendler said: “This label update builds upon the established efficacy and safety of IMBRUVICA in the frontline treatment of patients with CLL/SLL, as a monotherapy or in combination with other treatments.
“This milestone represents our continued commitment to develop IMBRUVICA-based, non-chemotherapy regimens to address the clinical needs of patients living with CLL/SLL.”
Imbruvica is a once-daily oral medicine, which works differently than chemotherapy as it blocks the BTK protein.
The BTK protein delivers crucial signals that tell B cells to mature and produce antibodies. BTK signaling is required needed by specific cancer cells to multiply and spread.
Imbruvica will allow to move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs through blocking BTK.
Imbruvica secured approval in over 90 countries and was used to treat over 135,000 patients across approved indications.
Imbruvica, which was first approved by the FDA in November 2013, is currently approved in six disease areas, including five hematologic cancers such as CLL with or without 17p deletion (del17p), SLL with or without del17p, Waldenström’s macroglobulinemia (WM), previously-treated patients with mantle cell lymphoma (MCL), previously-treated patients with marginal zone lymphoma (MZL) and previously-treated patients with chronic graft-versus-host disease (cGVHD).