Please login to the form below

Not currently logged in
Email:
Password:

Janssen's blood cancer drug Imbruvica approved in Europe

European commission licenses the first-in-class drug for two rare diseases

JanssenJanssen's Imbruvica (ibrutinib) has been approved in Europe as a treatment for two rare blood cancers.

The European Commission gave the drug the green light for its use in adults with relapsed or refractory mantle cell lymphoma (MCL), or chronic lymphocytic leukaemia (CLL).

In the case of CLL, patients must have received at least one prior therapy, or for first-line use in patients unsuitable for chemo-immunotherapy they must have either the 17p deletion or TP53 mutation chromosomal abnormality.

Jane Griffiths, company group chairman for Janssen, Europe, Middle East and Africa (EMEA), said: "We are delighted the European Commission has approved Imbruvica as a new treatment approach, which could prolong the lives of patients with these complex blood cancers.

"This is a positive step forward for patients, and Janssen is committed to looking into further areas of unmet need in blood cancers where Imbruvica could improve outcomes."

The first-in-class once-daily pill is a Bruton's tyrosine kinase (BTK) inhibitor that woks by blocking BTK, a protein that helps certain cancer cells live and grow.

The approval of Imbruvica, which has orphan drug status in Europe, was based on the phase III RESONATE study in CLL, which compared oral Imbruvica to GlaxoSmithKline's Arzerra (ofatumumab) given intravenously.

Janssen said its drug saw progression-free survival (PFS) results that represented a 78% reduction in the risk of progression or death compared to Arzerra; and a 57% reduction in the risk of death in patients receiving Imbruvica versus those receiving Arzerra.

Meanwhile, in a phase II study in relapsed or refractory MCL, Imbruvica was associated with an overall response rate of 68%, a complete response rate of 21% and a partial response rate of 47%. 

The drug's most common side effects include pneumonia, upper respiratory tract infection and sinusitis, and as part of Imbruvica's approval Janssen will implement a pharmacovigilance plan for the drug. 

Imbruvica was co-developed by Janssen and Pharmacyclics Switzerland - which will have co-marketing rights to the drug in the US, where it is approved in both MCL and CLL.

Article by
Dominic Tyer

20th October 2014

From: Sales

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Conversis

Conversis is a translation company specialising in translation and localisation for the Life Science and Pharmaceutical industry, with particular focus...

Latest intelligence

Navigating the antibiotic resistance crisis
Blue Latitude Health speaks to Tara DeBoer, PhD, Postdoctoral Researcher and CEO of BioAmp Diagnostics to explore the antimicrobial resistance crisis, and learn how a simple tool could support physicians...
Combined immunotherapies – potential and pitfalls
‘Combining therapeutic compounds is the first logical step towards better results, namely higher rates of patients responding to treatment, with deeper and more sustained responses’...
Report: Achieving launch excellence in the challenging healthcare markets of today
Our in-depth report is based on original data and expert interviews, which coupled with our own experience, ensures we give you the best recommendations for achieving launch success in challenging...

Infographics