AstraZeneca (AZN.L,AZN) and Merck & Co., Inc. (MRK) announced Wednesday that the US Food and Drug Administration (FDA) has approved Lynparza (olaparib) in the US for patients with homologous recombination repair or HRR gene-mutated metastatic castration-resistant prostate cancer or mCRPC.
Following this approval for Lynparza in the US, AstraZeneca will receive a regulatory milestone payment from Merck of $35 million.
The approval was based on results from the Phase III PROfound trial, which were published in The New England Journal of Medicine.
The primary endpoint of the trial was radiographic progression-free survival or rPFS in men with BRCA1/2 or ATM gene mutations, a subpopulation of HRR gene mutations. Results showed Lynparza reduced the risk of disease progression or death by 66% and improved rPFS.
The companies noted that prostate cancer is the second-most common cancer in men, and HRR gene mutations occur in approximately 20-30% of patients with mCRPC.
Lynparza is currently under regulatory review in the EU and other jurisdictions as a treatment for men with HRR gene-mutated mCRPC.
It was in July 2017 that AstraZeneca and Merck agreed on a strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor, and Koselugo, a kinase inhibitor, for multiple cancer types.
AstraZeneca and Merck are testing Lynparza in additional trials in metastatic prostate cancer including the ongoing Phase III PROpel trial as a 1st-line treatment in combination with abiraterone acetate for patients with mCRPC versus abiraterone acetate alone.
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