PFE plans to submit an NDA for Crizotinib (f/k/a PF-2341066) in second-line NSCLC in 2011, which is earlier than previously anticipated (and earlier than the posted trial completion date in http://clinicaltrials.gov/ct2/show/NCT00932893 ).
The phase-3 trial on which the NDA will be based tests Crizotinib monotherapy vs the clinician’s choice of Taxotere or Alimta. The primary endpoint is PFS.
ABT will furnish the gene test used to be Crizotinib screening if the drug is commercialized (#msg-40949294).
Source: PFE’s 2Q10 CC
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