Pfizer commences rolling FDA submission for lung cancer drug crizotinib; denies German VAT evasion

17 January 2011

Global pharma behemoth Pfizer (NYSE: PFE) last week started a rolling submission for a New Drug Application to the US Food and Drug Administration its lung cancer candidate crizotinib. The submission is expected to be completed in the first half of 2011.

Crizotinib is a first-in-class, oral anaplastic lymphoma kinase (ALK) inhibitor currently in Phase III trials for the treatment of advanced non-small cell lung cancer (NSCLC). The investigational drug is also being studied in Phase I trials for other tumor types.

“This action represents a significant step in the registration process for crizotinib (PF-02341066). Pfizer is committed to working collaboratively with the FDA as we move forward in the submission process with the ultimate goal of offering a new treatment option for patients with advanced ALK-positive NSCLC,” said Garry Nicholson, president and general manager of Pfizer’s Oncology business unit.

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