CACLP - The largest IVD Expo & Conference

FDA Approves Foundation Medicine CDx for Use with Janssen Drug in Prostate Cancer Patients

Industry news | 15 August, 2023 | CACLP

Original from: 360DX

 

Roche subsidiary Foundation Medicine announced on Monday that its FoundationOne CDx test received approval from the US Food and Drug Administration for use as a companion diagnostic for Janssen Biotech's Akeega (niraparib and abiraterone acetate).

 

The drug, administered in a dual-action tablet, was approved by the FDA to treat adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, Foundation Medicine said in a statement. FoundationOne CDx is a next-generation sequencing-based test that uses a tissue sample to analyze 324 cancer-related genes to detect genomic alterations in a patient's tumor and has more than 30 companion diagnostic indications.

 

"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, Foundation Medicine's chief medical officer, said in a statement, adding that FoundationOne CDx "specifically will help enable broader access to an important new therapy option" in BRCA-mutated metastatic castration-resistant prostate cancer.

Source: FDA Approves Foundation Medicine CDx for Use with Janssen Drug in Prostate Cancer Patients

 

Filed under:
Press contact CACLP - The largest IVD Expo & Conference

Stay in touch with CACLP News

We deliver the latest IVD news straight to your inbox. Stay in touch with CACLP News, sign-up for our newsletter today.

  • Name *
  • Email *
  • Company name *
  • Country *
    CACLP - The largest IVD Expo & Conference

By subscribing our newsletter, you agree to our Privacy Policy. You can unsubscribe at anytime.

Share
Opening Countdown
0 0 0

Day(s)

0 0

Hour(s)

0 0

Min(s)

Room 2201-2203 & 2205, Cloud Nine Plaza
1118 West Yan’an Road
Shanghai, China
200052

Copyright © 2024 GL events Ruihe (Shanghai) Exhibition Co., Ltd. All Rights Reserved. ( 沪ICP备12004745号-1 )

We use cookies to help provide you with the best possible online experience. Please read our Privacy Policy & Cookies for information about which cookies we use and what information we collect on our site. By continuing to use this site, you agree that we may store and access cookies on your device.

CACLP - The largest IVD Expo & Conference