AstraZeneca: FDA grants priority review to Lynparza
(CercleFinance.com) - US health regulators have granted a priority review for AstraZeneca and Merck's Lynparza as a treatment for advanced ovarian cancer, potentially accelerating the treatment's route to market.
The US Food and Drug Administration (FDA) has accepted priority review for the use of Lynparza tablets as a maintenance treatment in patients with newly-diagnosed, BRCA-mutated (BRCAm) advanced ovarian cancer, the drugmakers said.
The decision concerns patients who were in complete or partial response following first-line standard platinum-based chemotherapy, they said.
A priority review takes six months - rather than the usual 12 months. In this case, a decision date has been scheduled for the first quarter of 2019.
Lynparza is being jointly developed and marketed by AstraZeneca and Merck.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
The US Food and Drug Administration (FDA) has accepted priority review for the use of Lynparza tablets as a maintenance treatment in patients with newly-diagnosed, BRCA-mutated (BRCAm) advanced ovarian cancer, the drugmakers said.
The decision concerns patients who were in complete or partial response following first-line standard platinum-based chemotherapy, they said.
A priority review takes six months - rather than the usual 12 months. In this case, a decision date has been scheduled for the first quarter of 2019.
Lynparza is being jointly developed and marketed by AstraZeneca and Merck.
Copyright (c) 2018 CercleFinance.com. All rights reserved.