FDA approves Myriad’s BRACAnalysis CDx as companion diagnostic

21 December 2018 (Last Updated December 21st, 2018 11:53)

Myriad Genetics has announced that the US Food and Drug Administration (FDA) has approved the use of BRACAnalysis CDx as a companion diagnostic for AstraZeneca’s lynparza (olaparib) in patients suffering with advanced-stage, BRCA-mutated ovarian cancer.

FDA approves Myriad’s BRACAnalysis CDx as companion diagnostic
Micrograph of a low malignant potential (LMP) mucinous ovarian tumour. Credit: Nephron

Myriad Genetics has announced that the US Food and Drug Administration (FDA) has approved the use of BRACAnalysis CDx as a companion diagnostic for AstraZeneca’s lynparza (olaparib) in patients suffering with advanced-stage, BRCA-mutated ovarian cancer.

The BRACAnalysis CDx in-vitro diagnostic device can help health professionals in identifying advanced ovarian cancer patients with a germline BRCA mutation (gBRCAm) for first-line maintenance therapy with AstraZeneca’s PARP (poly ADP ribose polymerase) inhibitor lynparza (olaparib) after their response to platinum-based chemotherapy.

Myriad Oncology president Lloyd Sanders said: “We congratulate AstraZeneca and Merck on obtaining FDA approval of lynparza for patients with BRCAm advanced ovarian cancer, and we are excited to expand the use of BRACAnalysis CDx as the companion diagnostic test in this population.”

It is estimated that there are over 20,000 newly diagnosed patients with ovarian cancer in the US every year who can qualify for a BRACAnalysis CDx test.

“The FDA’s approval underscores the need for all patients with ovarian cancer to know their BRACAnalysis CDx results at the time of diagnosis.”

The FDA approval is based on results from the SOLO-1 trial that tested lynparza tablets as a maintenance treatment for patients suffering with advanced-stage BRCAm ovarian cancer.

These patients experienced a complete or partial response after first-line regular platinum-based chemotherapy.

The study results were published in the New England Journal of Medicine and indicated that lynparza maintenance therapy reduced the risk of disease progression or death by 70%.

Myriad Genetics gynecologic-oncologist and chief medical officer Johnathan Lancaster said: “In the SOLO1 trial, Myriad’s BRACAnalysis CDx test identified patients with advanced ovarian cancer who may benefit from lynparza.

“The FDA’s approval underscores the need for all patients with ovarian cancer to know their BRACAnalysis CDx results at the time of diagnosis so they can fully understand their treatment options.”

AstraZeneca and Merck & Co are commercialising lynparza.

In December 2014, the FDA approved BRACAnalysis CDx as a companion diagnostic to identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib.