Positive result should help change FDA's mind on Keytruda
Looking to overturn a regulatory rebuff, New Jersey, USA’s Merck & Co (NYSE: MRK) has announced positive event-free survival (EFS) data from the pivotal neoadjuvant/adjuvant Phase III study KEYNOTE-522.
The US Food and Drug Administration previously denied the firm an early approval in triple-negative breast cancer (TNBC), arguing that event-free survival data were not yet mature at the time of submission.
Now, after a median follow-up of over three years, statistical significance has been achieved.
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