FDA approves Genentech's breast cancer therapy, Foundation Medicine's CDx

Fda Sign Dc Social

The U.S. Food and Drug Administration (FDA) approved Foundation Medicine's FoundationOne Liquid CDx IVD test for use as a companion diagnostic (CDx) with Genentech's Itovebi (inavolisib) used in combination with palbociclib (Ibrance) and fulvestrant for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in certain adult patients.

The therapy was approved by the FDA concurrently. Roche is the parent company for both Genentech and Foundation Medicine. The combination therapy is used to treat adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence or after completing adjuvant endocrine therapy.

Approximately 70% of all breast cancers are HR positive, HER2 negative. PIK3CA is the most common mutated gene in HR-positive, HER2-negative breast cancer, with approximately 40% of patients having this mutation.

The FoundationOne Liquid CDx assay is a next-generation sequencing-based IVD test that uses targeted high-throughput hybridization-based capture technology to analyze 324 genes using circulating cell-free DNA from plasma taken from peripheral whole blood samples of patients. The test has been FDA-approved as a CDx for multiple indications to identify patients who may benefit from treatment with specific therapies following the approved therapeutic product labeling, including for prostate cancer.

Page 1 of 6
Next Page