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EMA accepts filings for crizotinib and bosutinib

European regulators have accepted Pfizer’s filings for two investigational cancer therapies

The European Medicines Agency has accepted for review Pfizer's filings for crizotinib for the treatment of non-small cell lung cancer (NSCLC) in previously treated patients with ALK-positive tumours and bosutinib for the treatment of newly diagnosed Philadelphia chromosome positive chronic myloid leukaemia.

The drugs are important components in Pfizer's pipeline, particularly crizotinib, which analysts are forecasting could provide billions of dollars in revenue for the US giant.

In May, the US Food and Drug Administration (FDA) granted crizotinib, a twice-daily, oral anaplastic lymphoma kinase inhibitor, a priority review. In the same month, Pfizer filed a marketing submission for the drug in Japan.

Pfizer has been in talks with regulators in the US about a submission for bostinib based on a pending longer term study. Phase III study results released in December 2010 showed that the drug failed to meet its primary endpoint of showing a 'superior complete cytogenic response' compared to Gleevec. However, the study also revealed that a significantly higher proportion of newly diagnosed patients treated with bosutinib experienced a major molecular response compared to patients treated with Gleevec.

The BELA study randomised 502 patients to receive bosutinib or Gleevec. After one year, 70 per cent of patients treated with Pfizer's drug experienced a cytogenic response, compared to 68 per cent of patients receiving Gleevec. For the secondary endpoint, 39 per cent of patients treated with bosutinib experienced a major molecular response, compared to 26 per cent of patients in the Gleevec arm.

Data also showed that fewer patients progressed to an advanced phase of disease, there were fewer deaths and patients responded faster to Pfizer's treatment. However, 25.4 per cent of patients treated with bosutinib experienced 'serious' adverse events, compared to 13.5 per cent of those receiving Gleevec.

18th August 2011

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