By Colin Kellaher
AstraZeneca PLC (AZN, AZN.LN) and Merck & Co. (MRK) on Tuesday said the U.S. Food and Drug Administration accepted and granted priority review to a supplemental new-drug application for Lynparza in a form of prostate cancer.
The drugmakers said the filing covers the treatment of patients with metastatic castration-resistant prostate cancer and deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations, who have progressed following prior treatment with a new hormonal agent.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.
AstraZeneca and Merck, which in 2017 formed a collaboration to co-develop and co-commercialize AstraZeneca's Lynparza for multiple cancer types, said the agency has set a target action date for the second quarter.
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