AstraZeneca plc AZN and partner Merck's MRK supplemental new drug application (sNDA) looking for label expansion of their PARP inhibitor Lynparza as a first-line maintenance treatment for advanced ovarian cancer was accepted by the FDA. With the FDA granting priority review, a decision is expected in the first quarter of 2019.
Lynparza is already marketed in the United States for platinum-sensitive relapsed ovarian cancer regardless of BRCA status and germline BRCAm HER2-negative metastatic breast cancer.
The sNDA filing was based on data from the pivotal phase III SOLO-1 study, which demonstrated that Lynparza (olaparib) tablets led to a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) compared to placebo in women with BRCA-mutated (BRCAm) advanced ovarian cancer who were in complete or partial response following first-line standard platinum-based chemotherapy. In the Lynparza arm, 60% of the patients were progression free at 36 months compared with 27% of women in the placebo arm.
This year so far, AstraZeneca's shares have risen 17.9% compared with the industry 's increase of 8.3%.
AstraZeneca reported Lynparza sales of $438 million in the first half of 2018, up 118% at constant exchange rates, on expanded use in ovarian cancer and label expansion in breast cancer. If approved for expanded use in the first-line setting, sales of Lynparza can improve in the future quarters.
Other PARP inhibitors available in the market are Tesaro, Inc.'s TSRO Zejula and Clovis Oncology, Inc.'s CLVS Rubraca. Zejula and Rubraca are also being evaluated in late-stage studies in the first-line maintenance setting in ovarian cancer patients who have responded to platinum chemotherapy.
AstraZeneca also announced presentation of detailed data from a phase III cardiovascular outcomes study, DECLARE- -TIMI 58, on type II diabetes drug Farxiga at the annual session of the American Heart Association.
In September, AstraZeneca had already announced that Farxiga led to statistical significant reduction in hospitalization for heart failure (hHF) or CV death in the study, thereby meeting one of the two primary efficacy endpoints. Along with the latest release, AstraZeneca said that Farxiga significantly reduced the combined risk of hHF or CV death by 17% versus placebo. Meanwhile, for the other endpoint, though fewer major adverse cardiovascular events (MACE) were observed in the Farxiga arm, this did not reach statistical significance (8.8% for Farxiga vs. 9.4% for placebo).
The DECLARE- -TIMI 58 cardiovascular outcomes study was carried out in type-II diabetes who have multiple CV risk factors or established CV disease. The study compared the effect of Farxiga versus placebo in reducing the risk of MACE in such patients.
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .
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Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Merck & Co., Inc. (MRK): Free Stock Analysis Report AstraZeneca PLC (AZN): Free Stock Analysis Report Clovis Oncology, Inc. (CLVS): Free Stock Analysis Report TESARO, Inc. (TSRO): Free Stock Analysis Report To read this article on Zacks.com click here. Zacks Investment Research