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Janssen withdraws attempt to extend Velcade indication in EU

Pulls bid to gain approval for the drug in non-Hodgkin lymphoma

Janssen has pulled its bid to extend the European licence of cancer drug Velcade with a new indication in non-Hodgkin lymphoma.

The Johnson & Johnson division had submitted an application to the European Medicines Agency (EMA) in September 2011 to consider the drug's use in combination with rituximab for the treatment of patients with relapsed follicular non-Hodgkin lymphoma – a cancer of B-cells in the body's lymphatic system.

However, the EMA has said Janssen has withdrawn this application for Velcade (botezomib) after the Agency's Committee for Medicinal Products for Human Use (CHMP) indicated that the data provided did not support a positive benefit-risk balance.

Velcade is already approved in Europe in two indications, receiving its first in April 2004 for use in combination with prednisone and GlaxoSmithKline's (GSK) Alkeran (melphalan) to treat patients with the bone marrow cancer multiple myeloma who are unsuitable for high-dose chemotherapy with a bone marrow transplant.

The drug was later approved as monotherapy to treat progressive multiple myeloma in patients who have received at least one prior therapy and have already had, or cannot receive, a bone marrow transplant.

A new indication would have opened up a new market for a drug nearing the end of its patent life into a therapy area with few alternative treatment options, allowing it to challenge Roche's MabThera/Rituxan (rituximab).

Nevertheless, Velcade remains one of Janssen/J&J's biggest selling products, bring the company over $1bn in revenues during 2011, despite a profit sharing agreement with co-developer Millennium Pharmaceutical, now part of Takeda.

The EMA said more information about the CHMP's thoughts on Velcade at the time of withdrawal will be available after the Committee's next meeting, which will be held July 16-19.

4th July 2012

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