Johnson & Johnson (J&J) has filed for approval in the US for its cancer drug ibrutinib, which was granted breakthrough status by the Food and Drug Administration (FDA) in February 2013.
The company’s Janssen Pharmaceuticals subsidiary submitted marketing applications for two B-cell malignancies, namely the second-line treatment of patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL).
Ibrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor licensed by J&J from Pharmacyclics in a deal involving an upfront payment of $150m – plus potential development and commercial milestones of $825m – in 2011.
The regulatory submission for ibrutinib is supported by data from two pivotal phase II studies, one in relapsed/refractory CLL/SLL and one in relapsed/refractory MCL, which were recently published in the New England Journal of Medicine on June 19.
The data show that ibrutinib achieved an overall response rate (ORR) of 68 per cent when used as a monotherapy in MCL and 41 per cent in CLL/SLL patients.
Analysts have suggested that ibrutinib could make annual sales of around $500m at peak across all its indications, with the lion’s share likely to come from its use in CLL, for which it is currently in three phase III trials.
Around 16,000 people are diagnosed with CLL in the US each year, and the current standard treatment for the disease is generally chemotherapy. However, many elderly patients with CLL are unable to tolerate aggressive therapy and patients whose malignancy is caused by a deletion of chromosome 17p typically are poor responders to treatment.
In trials, ibrutinib has demonstrated high overall responses and durable responses, irrespective of chromosome 17p status.
Ibrutinib has also been given breakthrough status by the FDA for Waldenstrom’s macroglobulinemia (WM), a type of non-Hodgkin lymphoma (NHL). A phase II study of the drug in WM presented earlier this year revealed an overall response rate of more than 80 per cent.
Janssen and Pharmacyclics are also developing the drug as a first-line therapy for CLL/SLL and MCL, and are looking at its potential in non-haematological tumours.