Janssen has submitted its drug ibrutinib to EU regulators for approval in the treatment of two forms of blood cancer.
The European Medicines Agency (EMA) will now determine if data provided by Janssen backs the use the drug in relapsed or refractory chronic lymphocytic leukaemia (CLL)/small lymphocytic leukaemia (SLL) and mantle cell lymphoma (MCL).
Ibrutinib is one of the most advanced drugs in the R&D portfolio of Janssen’s parent company Johnson & Johnson, and was named earlier this year as one of 10 new pharma products the company expects to file by 2017.
The once-daily, oral drug is the first in a new class of cancer medicines called Bruton’s tyrosine kinase (BTK) inhibitors, which treat the disease by bonding to the BTK protein in cancerous B cells to stop the cells proliferating.
Late-stage data has backed the drug’s ability to improve overall survival by several months, and analysts have predicted that ibrutinib could make $500m at peak across all its potential cancer indications.
The data has been positive enough to encourage the US Food and Drug Administration (FDA) to designate ibrutinib as a ‘breakthrough’ therapy, meaning the drug’s review will be accelerated and Janssen will be provided with more intensive FDA guidance during the review process.
Janssen filed for US approval of the drug in July this year after it received its breakthrough designation.
Jane Griffiths, chair of Janssen EMEA, described the EMA filing as an “important milestone” for ibrutinib.
She said: “If approved, ibrutinib will address a great unmet need for patients with CLL/SLL and MCL who have previously failed or become resistant to previous treatment.”