FDA Approves FoundationOne Liquid CDx for Niraparib/Abiraterone in Aggressive Prostate Most cancers


Prostate most cancers beneath the microscope: © heitipaves – inventory.adobe.com

  • FoundationOne Liquid CDx is now an FDA-approved companion machine for niraparib (zejula) and abiraterone acetate (Akeega) in deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate most cancers (mCRPC).
  • The tissue-based FoundationOne CDx was permitted in August 2023 for a similar remedy and indication.
  • This minimally invasive liquid biopsy permits for extra sufferers to be simply screened for BRCA mutations.

The FDA has permitted the FoundationOne Liquid CDx as a companion machine for the mixture remedy of niraparib and abiraterone acetate for the remedy of deleterious or suspected deleterious BRCA-mutated metastatic mCRPC.1

Niraparib/abiraterone is the primary and solely FDA-approved twin PARP inhibitor/hormone remedy. In August 2023, the FoundationOne CDx, a tissue-based complete genomic profiling check, was permitted for a similar remedy and indication.2

“We all know how difficult it may be to acquire a tissue pattern for testing in superior cancers similar to mCRPC, making liquid biopsy an extremely necessary device in a supplier’s toolbox for the event of customized remedy plans for his or her sufferers,” stated Mia Levy, MD, PhD, chief medical officer at Basis Medication, in a press launch.1 “The approval of our liquid biopsy check, together with the earlier approval for our tissue biopsy check, will allow extra sufferers to entry this necessary remedy choice. Moreover, with the flexibility to leverage a liquid-based check and reflex to a tissue-based check if wanted, healthcare suppliers can really feel assured they’ve correct genomic info at their fingertips to information remedy selections for sufferers.”

The FoundationOne Liquid CDx analyzes greater than 300 cancer-related genes from circulating cell-free DNA remoted from a blood pattern. The Liquid CDx additionally has further companion diagnostic indications in non–small cell lung most cancers, prostate most cancers, breast most cancers, colorectal most cancers, and NTRK1/2/2 fusions.

BRCA1- and BRCA2– mutated mCRPC make up about 11% of prostate most cancers diagnoses and is a extra aggressive type of the illness. Many sufferers nonetheless face a poor prognosis, based on Basis Medication.

“Males with aggressive prostate most cancers want and deserve extra choices,” stated Courtney Bugler, president and chief govt officer of ZERO Prostate Most cancers, in a press launch. “We applaud Basis Medication’s liquid biopsy check as a result of it empowers sufferers and households with extra instruments that may probably assist them lead longer, fuller lives.”

REFERENCES:
1. U.S. Meals and Drug Administration (FDA) approves FoundationOne®Liquid CDx as a companion diagnostic for AKEEGA® (niraparib and abiraterone acetate) for sufferers with BRCA-positive metastatic castration-resistant prostate most cancers. Information launch. Basis Medication, Inc. July 1, 2024. Accessed July 1, 2024. https://tinyurl.com/ytk3a7us
2. U.S. Meals and Drug Administration (FDA) approves FoundationOne®CDx as a companion diagnostic for Janssen’s AKEEGA™ (niraparib and abiraterone acetate Twin Motion Pill) for sufferers with BRCA-positive metastatic castration-resistant prostate most cancers. Information launch. Basis Medication, Inc. August 15, 2023. Accessed July 1, 2024. https://tinyurl.com/mt9abku8

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