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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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