Expanded Keytruda Approval Signals New Phase for Precision Medicine, May Benefit NGS Panel Makers

NEW YORK (GenomeWeb) – Over the past decade, as genomics research has transformed understanding of the origins and persistence of cancer, some experts predicted that one day drugs would be approved based on the molecular changes that drive abnormal cells, regardless of whether these cells are in the lung, colon, or breast.

With the approval of a new, tissue-agnostic, biomarker-guided indication for Merck’s Keytruda (pembrolizumab) the US Food and Drug Administration this week proved those prognosticators correct. Drug, diagnostic, and genomics experts agreed that FDA’s action, though restricted to advanced patients who have failed other therapies, represents the start of a major shift in how the field thinks about cancer care, and propels precision medicine into a new phase. And while the new indication didn’t come with an FDA-approved companion test, it places a spotlight on the need for well-validated diagnostics, and on next-generation sequencing cancer tests from companies such as Foundation Medicine, Personal Genome Diagnostics, and Guardant Health.

“This whole notion of a tissue-agnostic, biology-driven indication has become a reality,” said Roy Baynes, senior VP of global clinical development at Merck Research Laboratories. “One hopes this is a useful advance for the whole area of precision medicine.”

“I always

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