Specialty Pharma Journal Specialty, Precision & Technology
WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted priority review for the approval of LYNPARZA (olaparib) (two 150 mg …
Tag Archives: Olaparib
November, 2018
June, 2018
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27 June
Lynparza Significantly Delays Disease Progression in Phase 3 First-Line Trial for Ovarian Cancer
WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced positive results from the randomized, double-blinded, placebo-controlled, Phase III SOLO-1 trial of LYNPARZA® (olaparib) tablets (300 mg twice daily). Women with BRCA-mutated (BRCAm) advanced ovarian cancer treated 1st-line with LYNPARZA maintenance …
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5 June
Lynparza in Combination with Abiraterone Delayed Disease progression in Metastatic Castration-Resistant Prostate Cancer
WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today presented data, which showed clinical improvement in median radiologic progression-free survival (rPFS) with LYNPARZA® (olaparib) in combination with abiraterone compared to abiraterone monotherapy, a current standard of care, in metastatic …
May, 2018
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11 May
Scientists Identify Cause of Resistance to Breakthrough Breast and Ovarian Cancer Drug
Scientists have identified a mutation that gives cancer cells resistance to the breakthrough cancer treatment olaparib and other PARP inhibitors. The study findings could help predict which patients will develop resistance to PARP inhibitors and allow doctors to alter treatment at the earliest possible opportunity. A team at The Institute …
January, 2018
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12 January
FDA Approves AstraZeneca’s PARP Inhibitor to Treat Breast Cancer Patients with a BRCA Gene Mutation
The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP …
October, 2017
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18 October
FDA Grants Priority Review to AstraZeneca and Merck’s Lynparza in Metastatic Breast Cancer
WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental New Drug Application (sNDA) for the use of LYNPARZA® (olaparib) tablets in patients with germline BRCA-mutated …
June, 2017
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5 June
AstraZeneca’s Lynparza Significantly Reduces the Risk of Disease Worsening or Death in BRCA-Mutated Breast Cancer
WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today presented positive results from its Phase III OlympiAD trial that showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for patients treated with LYNPARZATM (olaparib) tablets (300 mg twice daily), compared to treatment with physician’s choice of a standard of care chemotherapy. In addition to …
March, 2017
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29 March
AstraZeneca’s Lynparza Granted FDA Priority Review for Maintenance Setting in Ovarian Cancer Patients
WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for LYNPARZA™ (olaparib) tablets (300mg twice daily) for use in platinum-sensitive, relapsed ovarian cancer patients in the maintenance setting. The FDA has also granted priority review status with a …
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15 March
AstraZeneca’s PARP Inhibitor Lynparza Demonstrates Positive Results in Late-Stage Ovarian Cancer Study
AstraZeneca today presented results from the Phase III SOLO-2 trial demonstrating a significant improvement in progression-free survival (PFS) in germline BRCA-mutated (gBRCA), platinum-sensitive, relapsed ovarian cancer patients treated with Lynparza (olaparib) tablets (300mg twice daily) compared with placebo in the maintenance setting. The trial met its primary endpoint of investigator …
October, 2016
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26 October
AstraZeneca’s Lynparza Shows Significant PFS Benefit in its Late-Stage Ovarian Cancer Trial
WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced positive results from the Phase III SOLO-2 trial designed to determine the efficacy of LYNPARZATM (olaparib) tablets (300mg twice daily) as a monotherapy for the maintenance treatment of platinum-sensitive relapsed, BRCA-mutated ovarian cancer.1 Results from the trial demonstrate a clinically-meaningful and statistically-significant improvement of progression-free …