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Breakthrough status for GSK/ Genmab's Arzerra

Speeds up FDA review for use in chronic lymphocytic leukaemia

FDA headquarters White Oak 

A new drug in development at GlaxoSmithKline (GSK) and Genmab for the most common form of adult leukaemia has been granted breakthrough status by the US Food and Drug Administration (FDA).

Arzerra (ofatumumab) has been submitted for approval in the US as a treatment alongside chlorambucil for patients with chronic lymphocytic leukaemia (CLL) who have not received prior treatment and are inappropriate for fludarabine-based therapy.

For Danish company Genmab it is a major achievement, as both of its lead drug programmes have now been designated breakthroughs by the US regulator.  The company's multiple myeloma therapy daratumumab - which is partnered with Johnson & Johnson - was awarded this status in May.

In trials, first-line treatment with Arzerra plus chlorambucil improved progression-free survival (PFS) in CLL patients and approval in this setting is considered to be critical for the drug's commercial success.

GSK has been selling Arzerra as a second-line therapy in CLL patients who are refractory to treatment with fludarabine and alemtuzumab since 2009, but sales have been modest - just £60m ($96m) last year for example - as the company has struggled to differentiate its product from Roche's Rituxan/ MabThera (rituximab) in the marketplace.

Breakthrough status is intended to accelerate development and review of drugs to treat serious medical conditions when preliminary clinical evidence shows "substantial improvement on at least one clinically significant endpoint over available therapies", notes GSK.

Breakthrough designation means that the company will have a higher level of contact with the FDA during the review process, which should also be shorter.

A few weeks ago Arzerra was one of a handful of already-marketed drugs that GSK chief executive Sir Andrew Witty said would be 'slow-burners', gradually building up sales momentum with the addition of new indications.

The anti-CD20 antibody is a direct competitor to Rituxan, sharing the same molecular target, but unlike its rival has been unable to show robust efficacy in indications such as non-Hodgkin's lymphoma, a much larger market than CLL.

It remains in phase III testing for other indications however, including relapsed CLL, follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL), and is also in phase II as a therapy for multiple sclerosis.

16th September 2013

From: Sales, Regulatory

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