AstraZeneca, Merck Get First FDA Nod for Lynparza in Prostate Cancer
May 20 2020 - 07:54AM
Dow Jones News
By Colin Kellaher
AstraZeneca PLC and Merck & Co. on Wednesday said the U.S.
Food and Drug Administration approved the cancer drug Lynparza for
its first indication in prostate cancer.
The drugmakers said the approval covers the treatment of
patients with deleterious or suspected deleterious germline or
somatic homologous recombination repair gene-mutated metastatic
castration-resistant prostate cancer who have progressed following
prior treatment with enzalutamide or abiraterone.
Such mutations occur in 20% to 30% of patients with metastatic
castration-resistant prostate cancer, the companies said.
Merck and AstraZeneca said patients will be selected for therapy
based on Myriad Genetics Inc.'s BRACAnalysis CDx genetic test,
which the FDA has approved as a companion diagnostic test with
Lynparza in the new indication.
AstraZeneca and Merck in 2017 formed a collaboration to
co-develop and co-commercialize Lynparza for multiple cancer
types.
Myriad's collaboration with AstraZeneca, which began in 2007,
has resulted in seven regulatory approvals for its BRACAnalysis CDx
in support of Lynparza.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
May 20, 2020 07:39 ET (11:39 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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