The company sought approval for the combination therapy to treat previously untreated mantle cell lymphoma (MCL) adult patients not suitable for autologous stem cell transplantation (ASCT).
Jointly developed and commercialised by AbbVie’s Pharmacyclics and Janssen Biotech, Imbruvica is a once-daily oral medication which blocks the Bruton’s tyrosine kinase (BTK) protein.
At present, the drug is approved to treat MCL patients who have previously received at least one line of therapy.
Janssen Research & Development Late Development, Diagnostics & Medical Affairs, Hematology & Oncology global head Craig Tendler said: “As the first approved BTK inhibitor, ibrutinib has now been used to treat more than 250,000 patients globally.
“It is also the first BTK inhibitor to be studied as a frontline treatment option for patients with mantle cell lymphoma.
“We are committed to the continued development of ibrutinib in B-cell malignancies where unmet needs remain in our efforts to make meaningful differences and change outcomes for patients.”
The application was based on data obtained from the double-blind, randomised, placebo-controlled Phase III SHINE study (NCT01776840).
In this trial, Imbruvica’s safety and efficacy was evaluated in combination with BR in previously untreated MCL adult patients aged 65 years and above.
The company stated that the therapy met the study’s primary endpoint of progression-free survival (PFS).
Last month, Janssen Biotech signed a research collaboration and license agreement with Mersana Therapeutics to discover new antibody-drug conjugates (ADCs) for three targets.