The European Medicines Agency has accepted global drugs behemoth Pfizer’s (NYSE: PFE) regulatory submissions for review of two investigational compounds - crizotinib, an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor, for the treatment of patients with previously treated ALK-positive advanced non-small cell lung cancer (NSCLC); and bosutinib for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase.
“With the EMA submissions for crizotinib and bosutinib, we are one step closer to potentially bringing two promising agents to patient populations in areas of significant unmet medical need,” said Andreas Penk, president of Pfizer Oncology Europe, noting that “these filings underscore Pfizer’s commitment to delivering innovative therapeutic treatment options targeting various tumor types and improving the outcome for cancer patients worldwide.”
US and Japanese filings for crizotinib in May
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