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Puma Aims To File Nerlynx In Third-line HER2-positive Breast Cancer By July

 
• By Sten Stovall

Puma's CEO voiced confidence the biotech's lead asset Nerlynx will be approved in third-line HER2-positive metastatic breast cancer after its Phase III NALA study met co-primary endpoints.

Carcinoma
Filings to be based on Positive top line results from Phase III NALA trial • Source: Shutterstock

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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