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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 approved LYNPARZA for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAmor sBRCAm) advanced epithelial …
Tag Archives: Lynparza
December, 2018
November, 2018
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12 November
FDA Grants Priority Review to Lynparza sNDA as Maintenance Therapy for Newly-Diagnosed, BRCAm Advanced 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 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 …
October, 2018
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24 October
Lynparza Maintenance Therapy Cut the Risk of Disease Progression or Death by 70% in BRCA-Mutated Ovarian Cancer in Phase 3 Trial
KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced detailed results from the Phase 3 SOLO-1 trial testing LYNPARZA 300 mg tablets twice daily as a maintenance treatment for patients with newly-diagnosed advanced BRCA-mutated (BRCAm) ovarian cancer who were in complete or partial …
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16 October
FDA Grants Orphan Drug Designation to Lynparza for Treatment of Pancreatic Cancer
KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) for LYNPARZA for the treatment of pancreatic cancer. LYNPARZA is currently being investigated as maintenance therapy in patients with germline BRCA-mutated …
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 …
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 …
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3 January
Myriad and AstraZeneca Partner on Phase 3 PARP Inhibitor Trial Utilizing myChoice HRD Plus as a Companion Diagnostic
SALT LAKE CITY, Jan. 03, 2018 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that AstraZeneca will use the Company’s myChoice® HRD Plus in an exploratory analysis to identify women with advanced ovarian cancer who may benefit from maintenance treatment with Lynparza …
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 …
July, 2017
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28 July
Merck and AstraZeneca Enter Strategic Oncology Collaboration
ENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that they have entered a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s LYNPARZA (olaparib) for multiple cancer types. LYNPARZA is an innovative, first-in-class oral poly ADP …