
FDA Approves FoundationOne CDx as Companion Diagnostic for Niraparib/Abiraterone in mCRPC
The FDA companion diagnostic designation for FoundationOne CDx may improve access to niraparib/abiraterone acetate for eligible patients with metastatic castration-resistant prostate cancer (mCRPC) harboring a BRCA mutation.
This article was originally published on
The FDA granted approval to the FoundationOne CDx as a companion diagnostic to identify patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (CRPC) who may benefit from treatment with niraparib and abiraterone dual action tablets (Akeega), according to a
“With such a rapidly evolving therapeutic landscape in prostate cancer, high-quality companion diagnostics are important tools to support oncologists in the development of personalized treatment plans for each unique patient,” Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, said in the press release. “This companion diagnostic specifically will help enable broader access to an important new therapy option in [BRCA1/2-mutated metastatic] CRPC.”
The
“We prospectively designed the MAGNITUDE study to identify the subset of patients most likely to benefit from targeted treatment with [niraparib and abiraterone acetate] and to help us understand how we can potentially achieve better health outcomes for patients,” principal investigator Kim Chi, MD, a medical oncologist at BC Cancer – Vancouver, said in a press release at the time of the agent’s FDA approval.2
FoundationOne CDx, a diagnostic test that uses next-generation sequencing, is designed to detect insertion and deletion alterations, as well as substitutions across 324 genes, helping to identify patients who may be eligible to receive targeted therapies based on approved therapeutic product labelling.
According to the press release, the assay is intended exclusively for prescription use. Additionally, testing with the FoundationOne CDx does not guarantee that a patient will be matched to a treatment, and a negative test result does not negate the potential presence of an alteration.
The
References
1. U.S. Food and Drug Administration (FDA) approves FoundationOne®CDx as a companion diagnostic for Janssen’s AKEEGA™ (niraparib and abiraterone acetate dual action tablet) for patients with BRCA-positive metastatic castration-resistant prostate cancer. News release. Foundation Medicine Inc. August 14, 2023. Accessed August 17, 2023. https://shorturl.at/OUWZ4
2. U.S. FDA approves AKEEGA™ (niraparib and abiraterone acetate), the first-and-only dual action tablet for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer. News release. Janssen Pharmaceutical Companies of Johnson & Johnson. August 11, 2023. Accessed August 17, 2023. https://bit.ly/3QBbT0d
3. FDA approves Foundation Medicine's FoundationOne®Liquid CDx, a comprehensive pan-tumor liquid biopsy test with multiple companion diagnostic indications for patients with advanced cancer. News release. Foundation Medicine Inc. August 26, 2020. Accessed August 17, 2023. https://shorturl.at/BHOP0
4. Foundation Medicine expands indication for FoundationOne®Liquid CDx to be used as a companion diagnostic for LYNPARZA®. News release. Foundation Medicine Inc. November 9, 2020. Accessed August 17, 2023. https://shorturl.at/EGLUZ
Newsletter
Stay ahead of policy, cost, and value—subscribe to AJMC for expert insights at the intersection of clinical care and health economics.