Two of Pfizer's investigational cancer drugs - one for leukaemia and another for lung cancer - have been accepted for review by the European Medicines Agency.
The EMA has said it would start reviewing applications for non-small cell lung cancer treatment crizotinib and bosutinib for chronic myeloid leukaemia, both of which cater for "significant unmet medical need," according to Dr. Andreas Penk, president of Pfizer Oncology Europe.
Crizotinib is an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor and has been filed as a treatment for ALK-positive advanced NSCLC patients in the EU. A filing in the same indication was submitted in the USA in May, with a priority review which could mean it becomes available by the end of the year. It has also been submitted to the Japanese Ministry of Health, Labour and Welfare.
Preliminary epidemiology suggests that approximately 3-5% of NSCLC tumours are ALK-positive, and Pfizer is working with Abbott to develop a companion diagnostic to help guide selection of patients for crizotinib therapy. Phase III trials are ongoing for the product in parallel with the regulatory filings based on Phase I and II data.
Meanwhile, bosutinib is a dual tyrosine kinase inhibitor which, in comparison with forerunners for CML treatment such as Novartis' Glivec/Gleevec (imatinib), tackles both Abl and Src kinases. It has been submitted for approval for the treatment of adult patients with newly-diagnosed Philadelphia chromosome positive (Ph+) CML in the chronic phase.
There has been speculation that this dual profile bosutinib may have activity in resistant CML disease, other myeloid malignancies and also solid tumours.