New Medicines

Xalkori ALK-positive anaplastic large cell lymphoma - second line or greater


Licence extension / variation

Development and Regulatory status

Phase II Clinical Trials
Pre-registration (Filed)
Oct 21Currently pre-registration in EU for a licence extension to include treatment of paediatric patients (age ≥ 6 to < 18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) and with unresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumour (IMT) for XALKORI based on the results from studies ADVL0912 and A8081013. The CHMP agreed to the request from the applicant for an extension to the clock stop to respond to the request for supplementary information adopted in September 2021 [9].
Jan 21US FDA approves crizotinib for treatment of ALK-positive anaplastic large cell lymphoma (ALCL) in children aged 1 year and above and young adults [8].
Sep 20Pfizer has agreed on a Pediatric Investigational Plan (PIP) for crizotinib for relapsed or refractory systemic ALK-positive anaplastic large cell lymphoma with European Medicines Agency [6].
Sep 20FDA accepts sNDA for Xalkori (crizotinib) for treatment ofpaediatric ALK-positive anaplastic large cell lymphoma [6].
Oct 19Not listed in Pfizer pipeline [5].
May 18Granted breakthrough therapy status in the US [1].


An oral, first-in-class, inhibitor of receptor tyrosine kinases, including anaplastic lymphoma kinase (ALK), ROS1 (c-ros oncogene 1) and hepatocyte growth factor receptor (HGFR, c-Met) [2].
Anaplastic large cell lymphoma (ALCL) is a rare type of non-Hodgkin lymphoma (NHL), but one of the more common subtypes of T-cell lymphoma. ALCL comprises about 2% of all NHLs and approximately 20% of all T-cell lymphomas. Patients with systemic ALCL may be ALK-positive or ALK-negative. Both of these lymphomas are treated as aggressive, yet many patients still relapse or require alternative treatment approaches. ALK-positive ALCL usually affects children and young adults [3].
ALK-positive anaplastic large cell lymphoma - second line or greater

Trial or other data

May 20Results posted for PI/II study (NCT00939770). Overall response in the ALCL cohort (n=10) is 70% [7].
Dec 19No results posted yet for PI/II study (NCT00939770) [4].
Dec 18PI/II study (NCT00939770) completes [4].
Nov 18PI study (NCT01121588) is due to complete collection of primary outcome data in Dec 19 [4].
May 18Breakthrough therapy status in the US was granted based on data from PIb and PII trials, Study ADVL0912 (NCT00939770) and Study A8081013 (NCT01121588) [3].

Evidence based evaluations