Payer News
February 2020
 

Advancing precision medicine for pancreatic cancer patients, Myriad obtains expanded BRACAnalysis CDx® indication


The U.S. Food and Drug Administration (FDA) has approved BRACAnalysis CDx as a companion diagnostic test to Lynparza® (olaparib), a PARP inhibitor. Its usage is to identify appropriate patients with pancreatic cancer eligible for treatment with Lynparza.

 

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BRACAnalysis CDx, the only FDA approved* germline companion diagnostic, expands diagnostic indications beyond breast cancer and ovarian cancer to now include pancreatic cancer 

 

 

 

Tumor Type Therapy
Pancreatic Cancer

Lynparza® (olaparib)

Breast Cancer

Lynparza® (olaparib)

Talzenna® (talazoparib)

Ovarian Cancer

Lynparza® (olaparib)- treatment/maintenance

Rubraca® (rucaparib)

For complete indication, see BRACAnalysis CDx Intended Use Statement. 

Important guidelines and precision medicine for Pancreatic Cancer Patients 

  • According to the NCCN Guidelines®**, patients with pancreatic cancer should have BRCA 1/2 testing 
  • Testing may identify patients who are eligible for olaparib maintenance treatment following first-line platinum-based chemotherapy. 

References 

* https://www.fda.gov/medical-devices/vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-vitro-and-imaging-tools 

**NCCN: Genetic/Familial High-Risk Assessment: Breast, Ovarian and Pancreatic   

Version 1.2020. © 2019 National Comprehensive Cancer Network  

Lynparza is a registered trademark of AstraZeneca 

Talzenna is a registered trademark of Pfizer 

Rubraca is a registered trademark of Clovis Oncology

     

Myriad Genetic Laboratories, Inc. 320 Wakara Way Salt Lake City UT 84108 United States

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