Poziotinib is active in EGFR exon 20 mutant lung cancer with efficacy highly dependent on insertion location

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A phase II clinical trial of poziotinib for non-small cell lung cancer with epidermal growth factor receptor exon 20 mutations, led by researchers at The University of Texas MD Anderson Cancer Center, found the drug had significant antitumor activity and the efficacy was highly dependent on the location of the exon 20 loop insertion, which may impact future clinical trials for EGFR exon 20 targeted therapies. 

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Companies vying for accelerated approval and devising strategies for confirmatory trials would be best served by seeking prospective sign-off from FDA, agency officials say.  Officials from the FDA Oncology Center of Excellence described these best practices in a perspective piece in the Sept. 21 issue of The New England Journal of Medicine and discussed the...