The approval allows the oral suspension to be utilised in treating CLL/ SLL, WM, and cGVHD following the failure of one or more lines of systemic therapy
Imbruvica inhibits the BTK protein inhibitor essential for the proliferation and spread of both normal and abnormal B cells. (Credit: Janssen Pharmaceutical Companies of Johnson & Johnson)
Johnson & Johnson and AbbVie’s Pharmacyclics have secured label expansion from the US Food and Drug Administration (FDA) for Imbruvica (ibrutinib) to include its oral suspension formulation for adult patients within its approved indications.
The approval allows the oral suspension to be utilised in treating chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft versus host disease (cGVHD) following the failure of one or more lines of systemic therapy.
Johnson & Johnson innovative medicine global medical affairs, oncology vice president Mark Wildgust said: “As the most comprehensively studied therapy in its class, Imbruvica has helped change the standard of care for adults living with certain blood cancers and cGVHD.
“Nearly 300,000 patients worldwide have been treated with Imbruvica to date, and we’re continually looking toward the future to help support additional patients.
“The approval of an Imbruvica oral suspension formulation underscores our commitment in providing innovative, alternate delivery options that address individualised patient needs and allow patients flexibility in how they take their medicine.”
Imbruvica, a once-daily oral medication, is a product of the collaboration between Johnson & Johnson’s subsidiary, Janssen Biotech, and Pharmacyclics.
The drug functions by inhibiting the Bruton tyrosine kinase (BTK) protein inhibitor essential for the proliferation and spread of both normal and abnormal B cells, including certain cancerous cells. By blocking BTK, Imbruvica aids in displacing abnormal B cells from their supportive environments and curbing their growth.
Currently, the drug is approved in over 100 countries.
Initially approved by the FDA in November 2013, Imbruvica is currently indicated for adult patients across four disease areas, including CLL/SLL with or without 17p deletion (del17p), Waldenström’s (WM), and cGVHD in both adult and paediatric patients aged one year and older who have not responded to prior systemic therapy.
Last year, AbbVie and Janssen Pharmaceutical announced plans to voluntarily withdraw the accelerated approvals of the BTK inhibitor in the US for mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) due to unexpected results in confirmatory trials.