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Date: 2014-10-17

Type of information: Granting of a Market Authorisation in the EU

Product name: Imbruvica®

Compound: ibrutinib

Therapeutic area: Cancer - Oncology - Rare diseases

Action mechanism:

Bruton tyrosine kinase inhibitor. Ibrutinib is administered orally, once-daily and is the first in a class of medicines called Bruton's tyrosine kinase (BTK) inhibitors. Data suggest ibrutinib covalently bonds to BTK in malignant B cells, shutting down major proliferation and survival pathways. Ibrutinib is being developed by Janssen with Pharmacyclics, Inc. for the treatment of several forms of blood cancer. If approved, ibrutinib will be the first commercially available therapy targeting BTK.

Company: Johnson&Johson (J&J) (USA - NJ)

Disease:

treatment of patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion),

Latest news:

* On October 17, 2014, Janssen-Cilag International announced  that the European Commission has approved Imbruvica® (ibrutinib) capsules. This  first-in-class, once-daily, oral Bruton's tyrosine kinase (BTK) inhibitor is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy

* On July 28, 2014, the FDA expanded the approved use of Imbruvica® (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica® received a breakthrough therapy designation for this use. The FDA is also approving new labeling to reflect that Imbruvica®’s clinical benefit in treating CLL has been verified. In February 2014, Imbruvica received accelerated approval to treat CLL based on its effect on overall response rate. New clinical trial results examining progression-free survival and overall survival have confirmed the drug’s clinical benefit.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2014-07-28

UE authorization: 2014-10-17

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes