AstraZeneca/Merck's Lynparza Wins EU Nod For First-Line Use
Zacks Investment Research | Jun 18, 2019 08:59AM ET
AstraZeneca plc. (NYSE:AZN) and partner Merck (NYSE:MRK) announced that the European Commission (EC) has granted marketing approval to their PARP inhibitor Lynparza for first-line maintenance treatment of BRCA-mutated advanced ovarian cancer. It was approved in the United States for the indication in late 2018.
With the latest approval, Lynparza can now be used as maintenance monotherapy for the treatment of advanced ovarian cancer patients with BRCA1/2 mutation who have achieved complete or partial response, following first-line standard platinum-based chemotherapy. The regulatory filing was based on data from the phase III SOLO-1 study, which showed that 60% of patients treated with Lynparza remained free of disease progression
after three years versus 27% on placebo.
The approval was expected as in April the Committee for Medicinal Products for Human Use of the European Medicines Agency gave a positive opinion recommending this label expansion of Lynparza. In April, Lynparza was also approved by EC for the breast cancer indication for which it was approved in the United States in early 2018.
Lynparza is presently approved for multiple indications in advanced ovarian cancer and metastatic breast cancer. It is also being evaluated in different studies for a range of tumor types including prostate, pancreatic and gastric cancers as well as earlier-line settings for ovarian cancer and breast cancer. A key phase III study, PAOLA-1 is evaluating Lynparza in combination with Roche’s Avastin as a first-line maintenance treatment for women with newly-diagnosed, advanced ovarian cancer, regardless of the BRCA status.
Other PARP inhibitors available in the market are Tesaro’s Zejula and Clovis Oncology, Inc.’s (NASDAQ:CLVS) Rubraca. Tesaro is now part of GlaxoSmithKline (NYSE:GSK) . However, Lynparza is the only PARP inhibitor approved in the EU as a first-line maintenance treatment for advanced ovarian cancer.
AstraZeneca’s stock has rallied 5.2% this year so far, outperforming the Original post
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.