COMPANY:

Foundation Medicine

"Itovebi is a therapy developed by Genentech, a member of the Roche group, which is approved for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy."

"Foundation Medicine...today announced that it has received approvals from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx and FoundationOne®Liquid CDx to be used as companion diagnostics for TALZENNA® (talazoparib) in combination with XTANDI® (enzalutamide) to identify patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). TALZENNA is first and only PARP inhibitor approved for use with an existing standard of care (XTANDI) for adult patients with both BRCA mutated and non-BRCA HRR gene-mutated mCRPC."

''Foundation Medicine, Inc...today announced plans to launch FoundationOne®PGx, a pharmacogenetic (PGx) offering to identify genetic differences that influence how medicines are metabolized and processed by the body. FoundationOne PGx will be offered in the United States through a partnership with Fulgent Genetics, Inc. (NASDAQ: FLGT) and will be available to order through the Foundation Medicine portal.''

''Foundation Medicine, Inc...today announced an expansion to its collaboration with Bristol Myers Squibb (NYSE: BMY) to develop FoundationOne®CDx as a next-generation sequencing-based companion diagnostic to identify patients with homozygous MTAP deletion in multiple indications for an investigational targeted therapy.''

''Foundation Medicine, Inc...announced it is set to expand its monitoring portfolio with SAGA Diagnostics’ tumor-informed molecular residual disease (MRD) platform as a result of Roche entering into a definitive merger agreement to acquire SAGA.''

P1/2 | "Early MR (by C2D1) was achieved in 35% of patients and strongly associated with improved rPFS and OS while PSA50 responses by C2D1 were not observed in any patients. The rPFS benefit of adding olaparib to radium-223 appeared more evident in those who achieved a MR. Early on treatment ctDNA dynamics in bone-dominant mCRPC may be a valuable tool for treatment decisions with radium-223 therapy."