FDA Approves Diagnostics for Olaparib, Abiraterone Combination Therapy in Patients With BRCA-Mutated mCRPC

The FDA has approved FoundationOne CDx and FoundationOne Liquid CDx to be utilized as companion diagnostics for olaparib (Lynparza; AstraZeneca, Merck) in combination with abiraterone and prednisone or prednisolone (the active form of prednisone) for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC), according to a news release from Foundation Medicine Inc.¹

These diagnostic tests will allow for more patients who may benefit from olaparib in combination with abiraterone to be identified. The standard CDx test analyzes over 300 cancer-related genes for genomic alterations in a patient’s tumor, while Liquid CDx does the same from a blood sample to provide genomic insights.¹

FoundationOne Liquid CDx was granted FDA approval in July 2024, in addition to the previously approved standard CDx tool, for patients with mCRPC who may benefit from the combination of niraparib (Zejula; GSK) and abiraterone. Now, the FDA has granted this approval status to the same devices, but with olaparib as a replacement for niraparib.^1,2

Olaparib in combination with abiraterone and prednisone or prednisolone was originally approved by the FDA in June 2023 for patients with mCRPC, helping meet the critically unmet need for treating the disease. Not only is prostate cancer one of the most common cancers in men, but BRCA-mutated mCRPC is a particularly aggressive form of the disease, occurring in 11% of diagnoses.^1,3

“This approval reinforces the importance of testing for genomic mutations at metastatic diagnosis to help guide treatment decisions,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, in the news release. “There is a critical unmet need for first-line treatment options for patients with BRCA-mutated metastatic castration-resistant prostate cancer and this combination therapy is an important advancement.”¹

Levy spoke to the ability of these devices to not differentiate between specimen type, and that, overall, patients will have more access to genomic testing, which helps to simplify complex decisions associated with treatment for mCRPC. The devices will provide genomic information, allowing for more proactive treatment management.¹

“This is an important milestone for men with aggressive prostate cancer,” Courtney Bugler, president and CEO of ZERO Prostate Cancer, said in the news release. “Biomarker testing is an important tool for patients and families to help facilitate personalized treatment decision making, and we applaud Foundation Medicine for these additional companion diagnostic indications.”¹

REFERENCES

1. Foundation Medicine, Inc. US Food and Drug Administration approves FoundationOne CDx and FoundationOne Liquid CDx as companion diagnostics for Lynparza (olaparib) in combination with abiraterone for patients with BRCA-mutated metastatic castration-resistant prostate cancer. BusinessWire. News Release. Released September 3, 2024. Accessed September 4, 2024. https://www.businesswire.com/news/home/20240903503030/en

2. Gerlach A. FoundationOne Liquid CDx receives FDA approval as a diagnostic tool for patients with BRCA-mutated mCRPC. Pharmacy Times. Published July 2, 2024. Accessed September 4, 2024. https://www.pharmacytimes.com/view/foundationone-liquid-cdx-receives-fda-approval-as-a-diagnostic-tool-for-patients-with-brca-mutated-mcrpc

3. Antrim A. FDA approves olaparib plus abiraterone, prednisone for metastatic castration-resistant prostate cancer. Pharmacy Times. Published June 1, 2023. Accessed September 4, 2024. https://www.pharmacytimes.com/view/fda-approves-olaparib-plus-abiraterone-prednisone-for-metastatic-castration-resistant-prostate-cancer