← Drug database

Xalkori (crizotinib)

Region

🇪🇺 EU

Active substance

crizotinib

Company

Pfizer Europe MA EEIG

Status

Authorised

Therapeutic area

Carcinoma, Non-Small-Cell Lung

CHMP opinion

Thu 19 Jul 2012

EU approval

Tue 23 Oct 2012

Application

EMEA/H/C/002489

ATC

L01ED01

Official record

www.ema.europa.eu

Indication

Xalkori as monotherapy is indicated for: The first line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) The treatment of adults with previously treated anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer (NSCLC) The treatment of adults with ROS1 positive advanced non small cell lung cancer (NSCLC) The treatment of paediatric patients (age 1 to <18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK) positive anaplastic large cell lymphoma (ALCL) The treatment of paediatric patients (age 1 to <18 years) with recurrent or refractory anaplastic lymphoma kinase (ALK) positive unresectable inflammatory myofibroblastic tumour (IMT)

Regulatory milestones

No milestones recorded in the last year.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.