Positive Clinical Results for Using Myriad’s BRACAnalysis CDx® for Identifying Breast Cancer Patients for Treatment with Lynaparza

more+
less-

Myriad Genetics recently announced clinical results showing that its BRACAnalysis CDx® test was able to identify patients with HER2-negative metastatic breast cancer who had improved response with Lynparza (olaparib), AstraZeneca’s PARP inhibitor. The results are based on a collaborative effort between Myriad Genetics and AstraZeneca for identification and treatment of patients with metastatic breast cancer and underlying BRCA 1/2 mutations.

In 2014, the FDA approved the use of BRACAnalysis CDx to identify patient with advanced ovarian cancer that would benefit from treatment with olaparib. Jonathan Lancaster, the chief medical officer of Myriad Genetics stated that, “we believe the results of the OlympiAD trial support use of BRACAnalysis CDx test to help inform treatment decisions in the metastatic breast cancer setting and will expand the patient population who can benefit from BRCA testing.”

The recent announcement is the first report of data from a Phase 3 Clinical Trial (the OlympiAD trial) that compares treatment options in Metastatic Breast Cancer Patients with Germline BRCA1/2 Mutations. The treatments compared the responses to Lynparza and so-called physician’s choice chemotherapy, where the investigators will choose Capecitabine, Vinorelbine, or Eribulin. Mydriad’s BRACAnalysis CDx test was used to identify patients with germline BRCA 1/2 mutations and these patients showed a statistically-significant improvement of progression-free survival when treated with olaparib compared to treatment with a chemotherapy of the physician’s choice.  Information about the clinical trial can be obtained here: https://clinicaltrials.gov/ct2/show/NCT02000622.

According to Myriad, BRACAnalysis CDx is an in vitro diagnostic device that detects and classifies variations of BRCA1 and BRCA2 in both protein coding and intron/exon junctions regions of the genes. The device analyzes genomic DNA obtained from whole blood. Small genetic variations including single nucleotide polymorphisms (SNPs) are identified using PCR with Sanger sequencing. Larger genetic variations, including large deletions and duplications, are detected using multiplex PCR.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Knobbe Martens Olson & Bear LLP | Attorney Advertising

Written by:

more+
less-

Knobbe Martens Olson & Bear LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×
Loading...
×
×