Molecular insights company Foundation Medicine Inc announced on Friday that it has received approval from the US Food and Drug Administration (FDA) for FoundationOneLiquid CDx as a companion diagnostic to identify patients who would benefit from treatment with Itovebi (inavolisib) in combination with palbociclib (Ibrance) and fulvestrant.
On Thursday, biotechnology company Genentech, part of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), said that the FDA had approved Itovebi, in combination with palbociclib and fulvestrant, for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer following recurrence on or after completing adjuvant endocrine therapy.
Approximately 70% of all breast cancers are hormone-receptor positive, HER2-negative. PIK3CA is the most commonly mutated gene in this form of breast cancer, found in approximately 40% of patients.
With this approval, Foundation Medicine now has seven companion diagnostic indications for breast cancer.
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