Positive top-line Phase III data testing Puma Biotechnology Inc.'s Nerlynx (neratinib) in third-line HER2-positive metastatic breast cancer, released this week will lead to talks with US and European regulators and follow-up filings for approval in that indication by next July, according to the biotech's CEO.
Alan Auerbach told analysts, "We would probably be looking to file ... in the June, July time frame." He was speaking after the NALA Phase III trial met its co-primary...
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