Crizotinib

Crizotinib (Xalkori, Pfizer Europe MA EEIG) has 5 EU-approved indications in 3 tumour types. Each needs a biomarker result: ALK (4) and ROS1 (1).
Approved indications of Crizotinib
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer3
ALK fusion
Monotherapy
1L
advanced
None
ALK fusion
Monotherapy
2L
advanced
Previously treated
ROS1 fusion
Monotherapy
Any line
advanced
None
T-cell lymphoma1
ALK fusion
Monotherapy
2L
Systemic ALCL only; Children and adolescents only; Relapsed or refractory; Age ≥ 1 to < 18 years
Other musculoskeletal tumours1
ALK fusion
Monotherapy
2L
advanced
Children and adolescents only; Recurrent or refractory; Age ≥ 1 to < 18 years
Full text of section 4.1 (therapeutic indications)

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)

Label history

43 changes to the Xalkori label since 2013, 4 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes