Please login to the form below

Not currently logged in
Email:
Password:

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However, the EMA has said Janssen has withdrawn this application for Velcade (botezomib) after the Agency's Committee for Medicinal Products for Human Use (CHMP) indicated that the data provided did not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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Adelphi Research UK

Adelphi Research UK is a healthcare insight partner. We uniquely blend robust market research with a consultancy approach, to guide...

Latest intelligence

What pharma marketers can learn from growth hacking?
Growth hackers instinctively blend technical skills with creative thinking...
Medicines for Europe
The sound of silence puts the squeeze on generics and biosimilars
Medicines for Europe vows to get governments talking to realise potential...
03_analytical_lowres.jpg
How to choose your digital channels
Like many other areas of marketing, pharma digital communication is subject to fashion. A new technology arrives, people naturally get excited. Meanwhile, established communication technologies receive less focus (even if...

Infographics