Foundation Medicine Receives Fda Approval for Foundationone Cdx as Companion Diagnostic for Itovebi in Combination with Palbociclib and Fulvestrant

Foundation Medicine Inc. has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx to be used as a companion diagnostic for Itovebi (inavolisib) in combination with palbociclib (Ibrance) and fulvestrant. 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. This decision from the FDA follows the approval of FoundationOne Liquid CDx, Foundation Medicine?s blood-based comprehensive genomic profiling (CGP) test, for the same therapy combination and indication in October 2024.

Of all breast cancer cases, approximately 70% are HR-positive, HER2-negative. Within this patient population, PIK3CA is mutated in approximately 40% of patients. An analysis of the agreement of identified PIK3CA mutation status between the FoundationOne CDx and FoundationOne Liquid CDx tests for patients in the INAV0120 trial demonstrated high concordance between the two assays.

Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. With this most recent approval, Foundation Medicine has eight FDA-approved companion diagnostic indications for breast cancer, and over 100 approved CDx indications in total, three times more than any other comprehensive genomic profiling company. FoundationOne CDx is for prescription use only and is an FDA-approved qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors.

The test analyzes 324 genes as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment.

A negative result does not rule out the presence of an alteration. Some patients may require a biopsy which may pose a risk. FoundationOne Liquid CDx is for prescription use only and is an FDA-approved qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors.

The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes, rearrangements in 8 genes and copy number alterations in 3 genes, and as a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment.

A negative result does not rule out the presence of an alteration. When considering eligibility for ROZLYTREK based on the detection of NTRK1/2/3 and ROS1 fusions, or for TEPMETKO based on the detection of MET SNVs and indels that lead to MET exon 14 skipping, testing using plasma specimens is only appropriate for patients for whom tumor tissue is not available for testing. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible.