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J&J’s Imbruvica wins new cancer indication

FDA backs drug’s use in chronic lymphocytic leukaemia patients with genetic mutation
FDA headquarters White Oak

Johnson & Johnson's (J&J) oncology ambitions continue to grow with another approval for Imbruvica in blood cancer.

The US FDA has recommended the drug for use in certain patients with chronic lymphocytic leukaemia (CLL), a rare blood and bone marrow disease which leads to a gradual increase in white blood cells called B lymphocytes.

The disease is estimated to be diagnosed in just under 16,000 people each year in the US and is expected to be the cause of 4,600 deaths in the country during 2014.

The approval for Imbruvica (ibrutinib) covers its use in people with CLL who are missing part of their chromosome 17. This is a rare genetic mutation that has been linked to a poor response to current CLL treatments.

Despite being found in just seven per cent of CLL patients who have yet to start treatment, between 20 and 40 per cent of people with CLL who relapse or are resistant to treatment have this mutation.

Imbruvica's approval in this group of patients is based on a clinical trial involving 391 people with CLL, 127 of whom had the deletion in chromosome 17.

Of these 127 participants - all of whom had received previous therapy - those treated with Imbruvica experienced a 75 per cent reduction in risk of disease progression or death.

Due to the unmet need in this area, and signs of Imbruvica's potential in early trials, the FDA designated the drug as a 'breakthrough' treatment, speeding up the review process.

It is the fourth drug approved by the FDA to treat CLL that has received this breakthrough designation following positive decisions for Roche's Gazyva (obinutuzumab) in November 2013, GlaxoSmithKline and Genmab's Arzerra (ofatumumab) in April 2014 and Gilead Science's Zydelig (idelalisib) just this month.

Imbruvica, which is to be marketed by J&J's pharma division Janssen and development partner Pharmacyclics, also received an update to its label to reflect that Imbruvica's clinical benefit in treating general CLL has been verified.

Earlier this year the drug received accelerated approval to treat CLL in patients who have received at least one prior therapy. Now further clinical studies have confirmed these benefits, allowing for the drug's full approval.

The decision marked a very positive month for J&J in cancer, with Imbruvica also winning a recommendation from the European Medicines Agency in the treatment of CLL and the news that the company's oncology revenues had grown by $500m for the first six months of 2014, hitting $2.1bn.

29th July 2014

From: Sales, Regulatory



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