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.

PHARMACOLOGY

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

CLINICAL STUDIES

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

References

  1. Xalkori Summary of Product Characteristics, October 2012.

View Xalkori drug record

Further information: Pfizer Ltd

Follow MIMS on Twitter

Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register
Already registered?
Sign in

More from MIMS

Gluten-free prescribing restricted to bread and mixes

Gluten-free prescribing restricted to bread and mixes

GPs in England are no longer able to prescribe gluten-free...

New vitamin D deficiency thresholds recommended

New vitamin D deficiency thresholds recommended

The National Osteoporosis Society (NOS) has updated...

SGLT2 inhibitors associated with increased risk of lower-limb amputation in new study

SGLT2 inhibitors associated with increased risk of lower-limb amputation in new study

SGLT2 inhibitors may be linked to a doubling in the...

New MIMS table helps prescribers choose asthma inhalers

New MIMS table helps prescribers choose asthma inhalers

Prescribers can now turn to a handy MIMS comparison...