Johnson & Johnson’s (J&J) Imbruvica has been approved in the US for a second indication, the treatment of patients with chronic lymphocytic leukaemia (CLL) who have failed first-line therapy.
Imbruvica (ibrutinib) was first given a green light by the FDA last November as a second-line treatment for mantle cell lymphoma (MCL), and the new use will expand the target population for the drug.
Approval in CLL was based on a 48-patient study which showed Imbruvica achieved a 58 per cent overall response rate (ORR), with the duration of responses ranging from a little over five months to around two years.
The responses were achieved despite the fact that the population enrolled was heavily pre-treated, with an average of four prior therapies.
The approval “provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy,” commented the FDA’s Richard Pazdur, director of the agency’s Office of Haematology and Oncology Products.
Last November Roche secured US approval for its own CLL therapy Gazyva (obinutuzumab) – which, like Imbruvica, had been given breakthrough status by the FDA – and both new drugs enter a CLL market currently dominated in value terms by Biogen Idec/Roche’s multibillion-dollar blockbuster Rituxan (rituximab).
Ibrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor licensed by J&J from Pharmacyclics in 2011 in a deal involving an upfront payment of $150m plus potential development and commercial milestones of $825m.
Around 15,700 patients were diagnosed with CLL in the US last year. Despite the relatively small patient population, Imbruvica’s $8,200 per month price tag means the new indication should provide a strong uptick in sales, although off-label use of the drug in CLL is already thought to be fairly widespread.
In Europe, a marketing application was submitted to EMA for the treatment of adult patients with relapsed or refractory CLL, small lymphocytic lymphoma, or relapsed or refractory MCL.
Analysts have predicted a broad peak sales range for the drug, from $500m a year right up $6bn-plus, as the drug’s oral delivery is expected to help it win share against its injectable rivals. In the coming years its toughest competition is likely to be from Gilead Sciences’ PI3K inhibitor idelalisib, which is currently under accelerated regulatory review in the US.