Posted by Michael Wonder on 20 Jan 2020
Lynparza regulatory submission granted priority review in the US for HRR-mutated metastatic castration-resistant prostate cancer
20 January 2020 - Submission based on PROfound, the first positive Phase III trial testing a targeted treatment in biomarker-selected prostate cancer patients.
AstraZeneca and MSD today announced that a supplemental new drug application for Lynparza (olaparib) has been accepted and granted priority review in the US for patients with metastatic castration-resistant prostate cancer and deleterious or suspected deleterious germ-line or somatic homologous recombination repair gene mutations, who have progressed following prior treatment with a new hormonal agent.
A Prescription Drug User Fee Act date is set for the second quarter of 2020.
