Tag Archives: metastatic breast cancer

August, 2018

23 August
Novartis’ Investigational PI3K inhibitor Meets Primary Endpoint in Phase 3 Breast Cancer Trial

Basel, August 23, 2018 – Novartis today announced the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) has met the primary endpoint showing an improvement in progression-free survival (PFS). SOLAR-1 is evaluating BYL719 in combination with fulvestrant compared to fulvestrant alone in postmenopausal women and men with …
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18 June
Published Case Report Demonstrates the Clinical Utility of Biocept’s CTC Platform in Metastatic Breast Cancer

SAN DIEGO, June 18, 2018 /PRNewswire/ — Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, announces the publication of a peer-reviewed case report demonstrating the clinical utility of its …
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7 June
Pfizer’s Talazoparib Granted FDA Priority Review for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) …
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31 January
Seattle Genetics to Acquire Cascadian Therapeutics for $614 Million, Adding Late-Stage Breast Cancer Program

att BOTHELL, Wash. & SEATTLE–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq:SGEN) and Cascadian Therapeutics, Inc. (Nasdaq:CASC) today announced the signing of a definitive merger agreement under which Seattle Genetics has agreed to acquire Cascadian Therapeutics. Under the terms of the agreement, Seattle Genetics will pay $10.00 per share in cash, or approximately $614 …
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7 December
Pfizer Announces Updated Progression-Free Survival Results from Late-Stage Trial Reinforcing the Benefit of Ibrance Plus Letrozole in Breast Cancer

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced updated progression-free survival (PFS) results from the Phase 3 PALOMA-2 trial reinforcing the clinical benefit of IBRANCE® (palbociclib) combined with letrozole. The data, which will be presented at the 2017 San Antonio Breast Cancer Symposium (SABCS) on December 8 [abstract #P5-21-03], demonstrate that the …
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15 November
FDA Approves AstraZeneca’s Faslodex for the Treatment of Advanced Breast Cancer in Combination with Abemaciclib

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication for FASLODEX® (fulvestrant), expanding the indication to include use with abemaciclib, a CDK4/6 inhibitor, for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast …
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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 …
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29 September
FDA Approves Lilly’s Verzenio for Treatment of Advanced or Metastatic Breast Cancer

The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy). Verzenio is approved to be given …
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8 May
Oncolytics Biotech’s Reolysin Granted Fast Track Designation by the FDA in Metastatic Breast Cancer

CALGARY, May 8, 2017 /PRNewswire/ – Oncolytics Biotech® Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) announced today that the United States Food and Drug Administration (FDA) has granted Fast Track designation for REOLYSIN®, the Company’s proprietary immuno-oncology viral agent, for the treatment of metastatic breast cancer. “Fast Track designation represents …
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15 March
FDA Approves Novartis’ Kisqali for Treatment of Advanced or Metastatic Breast Cancer

Basel, March 13, 2017 – The US Food and Drug Administration (FDA) has approved Kisqali®(ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. Kisqali …
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