San Francisco, CA (UroToday.com) -- Foundation Medicine, Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for LYNPARZA® (olaparib), which was also approved in the U.S. for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. FoundationOne CDx is the only FDA-approved comprehensive genomic profiling (CGP) test for all solid tumors that incorporates multiple companion diagnostic claims.
Prostate cancer is the second most common cancer in men; 1 in 9 will be diagnosed during their lifetime.1 mCRPC occurs when prostate cancer grows and spreads to other parts of the body despite the use of androgen-deprivation therapy to block the action of male sex hormones.2 Because there have previously been limited treatment options for this specific disease area, there is generally a high mortality rate.
“This therapy and companion diagnostic approval underscores the value of comprehensive genomic profiling in advanced cancer patients as it validates our ability to identify alterations in the 14 HRR pathway genes within FoundationOne CDx’s 324 gene panel that indicate a patient may be eligible for treatment with Lynparza, a process not possible through single gene or hot spot testing,” said Brian Alexander, M.D., M.P.H., chief medical officer at Foundation Medicine. “This is an important advancement for patients with HRR-mutated metastatic castration-resistant prostate cancer, as there have previously been limited treatment options available for this specific condition.”FoundationOne CDx is the first FDA-approved broad companion diagnostic that is clinically and analytically validated for solid tumors. FoundationOne CDx is currently approved as a companion diagnostic for more than 20 targeted therapies.
LYNPARZA was approved based on the PROfound study, which was supported by Foundation Medicine and was the first phase III biomarker-selected study using a molecularly targeted treatment in men with metastatic castration-resistant prostate cancer (mCRPC) to demonstrate improved outcomes. The PROfound trial is the largest prospective study to date performing central tissue testing for homologous recombination repair (HRR) gene mutations in mCRPC patients. The clinical trial assay (CTA) is an NGS assay based on FoundationOne CDx.
LYNPARZA is jointly developed and commercialized by AstraZeneca and Merck & Co., Inc.
Source: "Foundation Medicine Receives FDA Approval For Foundationone®Cdx As The Companion Diagnostic For LYNPARZA® To Identify Patients With HRR-Mutated Metastatic Castration-Resistant Prostate Cancer". 2020. Foundation Medicine.
References:
1. "Key Statistics For Prostate Cancer | Prostate Cancer Facts". 2020. Cancer.Org.
2. "Treatment Of Metastatic Castration-Resistant Prostate Cancer". 2020. Cancer.Net.
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