The FDA has approved a companion diagnostic from Guardant Health to identify patients eligible for treatment with a targeted therapy developed by Pfizer and Arvinas.
The blood-based test detects ESR1 mutations in patients with estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer whose disease has progressed after at least one line of endocrine therapy, according to a May 4 Guardant Health news release.
The approval enables a noninvasive approach to guide treatment selection, as ESR1 mutations are linked to resistance to endocrine therapy. The therapy, developed by Arvinas and Pfizer, is designed to degrade the estrogen receptor and target tumors driven by ESR1 mutations, the release said.
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