AstraZeneca: FDA priority review for prostate cancer drug
(CercleFinance.com) - AstraZeneca said that its drug that blocks DNA damage response in tumours has been granted a priority review status by the US Food and Drug Administration for patients with metastatic castration-resistant prostate cancer, accelerating steps towards its regulatory approval.
The Anglo-Swedish company said that a supplemental new drug application for Lynparza has been accepted and granted priority review for patients with metastatic castration-resistant prostate cancer (mCRPC).
The designation covers patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations, whose disease has progressed following prior treatment.
A decision date has been set for the second quarter of 2020.
Lynparza is being jointly developed and commercialised by AstraZeneca and US drugmaker Merck.
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The Anglo-Swedish company said that a supplemental new drug application for Lynparza has been accepted and granted priority review for patients with metastatic castration-resistant prostate cancer (mCRPC).
The designation covers patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations, whose disease has progressed following prior treatment.
A decision date has been set for the second quarter of 2020.
Lynparza is being jointly developed and commercialised by AstraZeneca and US drugmaker Merck.
Copyright (c) 2020 CercleFinance.com. All rights reserved.