Specialty Pharma Journal Specialty, Precision & Technology
Darmstadt, Germany, and New York, US, December 21, 2018 – Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) today announced that data from a planned interim analysis of the Phase III JAVELIN Ovarian 100 study of avelumab* did not support the study’s initial hypothesis, and therefore the alliance made …
Tag Archives: ovarian cancer
December, 2018
November, 2018
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19 November
Avelumab Fails to Meet Primary Endpoints in Late-Stage Platinum-Resistant/Refractory Ovarian Cancer Trial
Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) today announced that the Phase III JAVELIN Ovarian 200 trial evaluating avelumab* alone or in combination with pegylated liposomal doxorubicin (PLD), a type of chemotherapy, compared with PLD did not meet the prespecified primary endpoints of overall survival (OS) or progression-free …
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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 …
August, 2018
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20 August
FDA Grants Fast Track Designation to Aravive Biologics’ AVB-S6-500 for Treatment of Ovarian Cancer
HOUSTON–(BUSINESS WIRE)–Aravive Biologics, Inc. announced today that the U.S. Food and Drug Administration has granted Fast Track Designation to AVB-S6-500 as a potential treatment for platinum-resistant recurrent ovarian cancer. “Gaining Fast Track Designation is an important recognition of the potential that AVB-S6-500 has to offer to meet a critical unmet …
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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18 June
FDA Grants Fast Track Status to ImmunoGen’s Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer
WALTHAM, Mass.–(BUSINESS WIRE)–ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead program, mirvetuximab soravtansine. The designation is for the treatment of patients with …
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13 June
FDA Approves Genentech’s Avastin Plus Chemotherapy for Women with Advanced Ovarian Cancer Following Surgery
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Avastin® (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with advanced (stage III or IV) …
May, 2018
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18 May
Ovarian Cancer Drug Shows Promise in Pancreatic Cancer Patients with BRCA Mutation
PHILADELPHIA – A targeted therapy that has shown its power in fighting ovarian cancer in women including those with BRCA1 and BRCA2 mutations may also help patients with aggressive pancreatic cancer who harbor these mutations and have few or no other treatment options. An international team of researchers led by the Perelman School of Medicine and the Basser Center …
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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 …