Xalkori: targeted treatment for ALK-positive non-small cell lung cancer

Pfizer has launched Xalkori (crizotinib) for previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Symptoms of NSCLC include haemoptysis, shortness of breath, wheezing, chest pain, loss of appetite, unexplained weight loss and fatigue.
Symptoms of NSCLC include haemoptysis, shortness of breath, wheezing, chest pain, loss of appetite, unexplained weight loss and fatigue.


Crizotinib selectively inhibits the ALK receptor tyrosine kinase and its oncogenic variants, including the fusion protein EML4-ALK. It demonstrated potent growth inhibition and induced apoptosis in tumour cell lines exhibiting ALK fusion events.1


Crizotinib was evaluated in two single-arm studies involving 386 patients with ALK-positive NSCLC who had received prior systemic therapy for locally advanced or metastatic disease. Patients received crizotinib 250mg twice daily and investigators used the objective response rate (ORR), according to Response Evaluation Criteria in Solid Tumours (RECIST), as the primary efficacy endpoint.1

Reponse rate

The ORR was 60% in the first study (95% CI 51–69) and 53% in the second study (95% CI 47–60). Responses lasted for a median of 48.1 weeks in the first study and 42.9 weeks in the second study. Median progression-free survival in the two studies was 9.2 months and 8.5 months, respectively.1

Side-effect profile

The most common (>20%) adverse events observed with crizotinib were vision disorders, nausea, diarrhoea, vomiting, oedema, constipation and fatigue.1

Conditional approval

Xalkori has been given conditional marketing approval pending further evidence of clinical benefit, including the results of a comparative study versus standard chemotherapy with pemetrexed or docetaxel.1


  1. Xalkori Summary of Product Characteristics, October 2012.

View Xalkori drug record

Further information: Pfizer Ltd

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