FDA Approves Pan Tumor Liquid Biopsy Test to ID Patients for Treatment with Lynparza

FDA has approved FoundationOne Liquid CDx, from Foundation Medicine, Cambridge, Mass, to be used as a companion diagnostic for Lynparza (olaparib). As a companion diagnostic, FoundationOne Liquid CDx will use a blood-based biopsy to identify patients with BRCA1, BRCA2, and/or ATM alterations in metastatic castration-resistant prostate cancer (mCRPC) who may be appropriate for treatment with Lynparza.

FoundationOne Liquid CDx was approved by the FDA in August 2020 to report genomic alteration results for patients with any solid tumor.

Prostate cancer is the second most common cancer in men globally, and despite progress made toward new treatment modalities, the mortality rate for this condition remains high. Of critical importance is ensuring metastatic prostate cancer patients receive comprehensive genomic profiling (CGP) via liquid or tissue-based biopsies to determine eligibility for new targeted treatment options such as Lynparza. FoundationMedicine’s tissue-based comprehensive genomic profiling test, FoundationOne CDx, was approved as a companion diagnostic for Lynparza in May 2020.

“With this latest companion diagnostic approval, physicians now have the option to choose either tissue or liquid-based comprehensive genomic testing based on their patients’ need and condition,” says Brian Alexander, MD, MPH, chief medical officer at Foundation Medicine. “Since tissue availability can be an issue for some metastatic prostate cancer patients, blood-based testing is an important option to consider and critically important for informing patient care. The approval of this companion diagnostic will allow more patients to access genomic testing, regardless of specimen type, and provide oncologists with another tool to guide personalized treatment decisions.”

Using a blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes for genomic alterations. The CGP test is now approved as a companion diagnostic for seven targeted therapies across four tumor types.

For more information, visit Foundation Medicine.