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AstraZeneca's Lynparza Gets Priority Review in 1st Line Use
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AstraZeneca plc (AZN - Free Report) and partner Merck’s (MRK - Free Report) 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 Zejula and Clovis Oncology, Inc.’s 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.
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
AstraZeneca's Lynparza Gets Priority Review in 1st Line Use
AstraZeneca plc (AZN - Free Report) and partner Merck’s (MRK - Free Report) 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 Zejula and Clovis Oncology, Inc.’s 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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