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FDA says Janssen's myeloma drug is a 'breakthrough therapy'

Should speed up regulatory process for daratumumab

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Janssen's investigational multiple myeloma drug daratumumab has been granted 'breakthrough therapy designation' by the US FDA.

This status does not guarantee approval for the human CD38 monoclonal antibody but, like the FDA's long-established fast-track programme, it should speed up the process.

Created by the 2012 FDA Safety & Innovation Act (FDASIA), “breakthrough” drugs are deemed to show substantial improvement over existing therapies for serious and unmet medical needs.

Janssen, a subsidiary of Johnson & Johnson (J&J), believes daratumumab could treat multiple myeloma patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent, or who cannot take either.

Currently in phase I/II trials, the drug was originally developed by Danish company Genmab, but last August, Janssen acquired global development and commercialisation.

While Janssen is downplaying the FDA's decision by saying its implications “cannot be determined at this time”, it is clearly good news and may have an influence over ongoing and planned development activities.

Multiple myeloma is a cancer of plasma cells and kills more than 10,000 people in the US each year. The five-year relative survival rate is around 40 per cent and new treatments are in demand.

“Our team is looking forward to the opportunity to work closely with the FDA on the development programme of this compound, which has the potential to make a difference in the lives of patients,” said Peter Lebowitz, Janssen's global oncology therapeutic area head.

It is the second Janssen drug to be singled out in this way by the FDA in the past few months, following breakthrough designation for ibrutinib, an oral treatment designed to target and inhibit the enzyme Bruton's tyrosine kinase.

This compound is being co-developed with Pharmacyclics, and the companies hope it will gain approval as monotherapy for three B-cell malignancies: chronic lymphocytic leukaemia or small lymphocytic lymphoma with deletion of the short arm of chromosome 17; refractory mantle cell lymphoma; and Waldenström's macroglobulinemia.

The FDA has granted breakthrough status to several investigational therapies recently, classing Novartis' oncology drug LDK378 under this status in March 2013 for metastatic non-small cell lung cancer (NSCLC) patients who test positive for a genetic mutation known as anaplastic lymphoma kinase (ALK) and are unable to be treated with Pfizer's recently-launched Xalkori (crizotinib).

The first published FDA breakthrough therapy designations were awarded to Vertex Pharma for its cystic fibrosis candidates Kalydeco (ivacaftor) and the combination of Kalydeco and VX-809.

3rd May 2013

From: Sales

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