Johnson & Johnson (J&J) has announced that Imbruvica (ibrutinib) has been approved by the European Commission (EC) as a first-line treatment for adults with mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplant (ASCT).
The drug has been authorised for use in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP), alternating with rituximab, dexamethasone, cytarabine and cisplatin or oxaliplatin (R‑DHAP/R‑DHAOx) without Imbruvica, followed by Imbruvica monotherapy.
Around one to two per 100,000 people worldwide are diagnosed with MCL, an aggressive form of blood cancer, every year. Despite advances, the disease remains difficult to treat, with many patients relapsing or becoming resistant to therapy.
The EC’s latest decision on Imbruvica, which is already approved in the EU to treat relapsed or refractory MCL, was supported by positive results from the late-stage TRIANGLE trial conducted by the European MCL Network.
At a median follow-up of 55 months, Imbruvica used alongside chemoimmunotherapy (CIT), with or without ASCT, was associated with significantly superior failure-free survival (FFS) compared to ASCT plus CIT alone.
Imbruvica in combination with CIT also provided significantly longer overall survival versus ASCT plus CIT, and the overall safety profile of the Imbruvica/CIT regimen was consistent with the previously known safety profile of the drug.
Imbruvica, which is jointly developed and commercialised by J&J’s Janssen Biotech and AbbVie company Pharmacyclics, is designed to block the BTK protein that normal and abnormal B-cells require to multiply and spread.
Beyond MCL, the drug is approved in the EU to treat certain cases of chronic lymphocytic leukaemia and Waldenström’s macroglobulinaemia.
Ester in ‘t Groen, EMEA therapeutic area head haematology, J&J Innovative Medicine, said: “For more than a decade, [Imbruvica] has been the standard of care in relapsed or refractory MCL, transforming patient outcomes in later lines.
“Today’s approval for frontline use offers patients facing this aggressive blood cancer improved survival outcomes from the outset of treatment.”
Jessica Vermeulen, vice president, lymphoma and leukaemia disease area stronghold leader, J&J Innovative Medicine, added: “We’re incredibly proud that with this approval, [Imbruvica] has become the first alternative therapy for this patient population after demonstrating superior outcomes compared to the current standard of care.”