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Home Industry News Janssen receives EU blood cancer approvals for Imbruvica

Janssen receives EU blood cancer approvals for Imbruvica

20th October 2014

Janssen has announced that its first-in-class, once-daily, oral Bruton's tyrosine kinase (BTK) inhibitor Imbruvica has been approved in two new blood cancer indications.

The drug has been ratified by the European Commission for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, or chronic lymphocytic leukaemia. The therapy functions by blocking BTK, a protein that helps cancer cells to develop.

Imbruvica is indicated for people who have received at least one prior therapy, or for the first-line treatment in the presence of 17p deletion or TP53 mutation for patients unsuitable for chemo-immunotherapy.

The decision follows a positive opinion from the Committee for Medicinal Products for Human Use and will see the drug become available in these new indications in all 28 EU countries.

Jane Griffiths, company group chairman at Janssen in the Europe, Middle East and Africa, said: "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 drug was developed jointly by Janssen and Pharmacyclics Switzerland and was approved by the US Food and Drug Administration for the treatment of chronic lymphocytic leukaemia earlier this year.ADNFCR-8000103-ID-801755231-ADNFCR

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