publication date: Mar. 1, 2019

Clinical Roundup

BRACAnalysis CDx test identified patients with pancreatic cancer who benefitted from Olaparib

Myriad Genetics Inc. said the phase III POLO study demonstrated its BRACAnalysis CDx  test successfully identified patients with metastatic pancreatic cancer who have BRCA mutations and benefitted from treatment with olaparib, a novel PARP inhibitor.

Myriad plans to file a supplementary Premarket Approval application with FDA to authorize BRCAnalysis CDx as a companion diagnostic for olaparib in this indication and has an exclusive commercialization agreement.

The topline results—announced earlier by AstraZeneca and MSD Inc.—are the first reported clinical data from the POLO study (NCT02184195), which assessed the efficacy of olaparib as first-line maintenance monotherapy in patients with germline BRCA-mutated, metastatic pancreatic cancer whose disease had not progressed on platinum-based chemotherapy. The results demonstrated a statistically-significant and clinically-meaningful improvement of progression-free survival among BRCA-mutated patients treated with olaparib compared to placebo.

BRACAnalysis CDx is the only FDA-approved germline BRCA1/2 test.

Olaparib is being commercialized by AstraZeneca and MSD Inc. The collaboration between Myriad and AstraZeneca on olaparib began in 2007 and has resulted in multiple regulatory approvals for BRACAnalysis CDx.

December 2018: FDA approved BRACAnalysis CDx as a companion diagnostic to identify patients newly diagnosed with advanced ovarian cancer who are eligible for first-line maintenance treatment with olaparib.

March 2018:  The Japanese Ministry of Health, Labour, and Welfare approved BRACAnalysis CDx as a companion diagnostic to identify patients with metastatic breast cancer who are eligible for second-line treatment with olaparib.

January 2018:  FDA approved BRACAnalysis CDx as a companion diagnostic to identify patients with metastatic breast cancer who are eligible for second-line treatment with olaparib.

August … Continue reading BRACAnalysis CDx test identified patients with pancreatic cancer who benefitted from Olaparib

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