Foundation Medicine Receives 2nd CDx Indication of the Week With FDA Approval for BRAF V600E mutations in Pfizer Combination Therapy for NSCLC

Foundation Medicine Inc. announced that the U.S. Food and Drug Administration (FDA) has approved both its FoundationOne®CDx and FoundationOne®Liquid CDx tests to be utilized as companion diagnostics for Pfizer’s BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib). These diagnostics have been approved for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring a BRAF V600E mutation.

Non-small cell lung cancer is the most prevalent form of lung cancer, accounting for 80-85% of lung cancer diagnoses. Within this patient population, approximately 2% have BRAF V600E mutations. The combination of BRAFTOVI and MEKTOVI is a targeted therapy using kinase inhibitors that work by blocking enzymes, preventing cancer cells from proliferating. This therapy combination was previously approved for the treatment of patients with unresectable or metastatic melanoma who have a BRAF V600E or V600K mutation, as identified by an FDA-approved test.

The FDA-approved FoundationOne CDx test scrutinizes more than 300 cancer-related genes in a patient’s tumor using a tissue sample. Currently, it boasts over 30 companion diagnostic indications. Meanwhile, FoundationOne Liquid CDx utilizes a simple blood sample to analyze over 300 cancer-related genes and the company has received 60% of all companion diagnostic indications pertaining to next generation sequencing. Earlier this week, the company received a companion diagnostic indication for Eli Lilly and Company’s Retevmo (selpercatinib) in patients that have rare RET gene fusions.