Navigation Links
Syndax's Entinostat Receives Breakthrough Therapy Designation from FDA for Treatment of Advanced Breast Cancer
Date:9/11/2013

WALTHAM, Mass., Sept. 11, 2013 /PRNewswire/ -- Syndax Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated entinostat as a Breakthrough Therapy for the treatment of locally recurrent or metastatic estrogen receptor-positive (ER+) breast cancer when added to exemestane in postmenopausal women whose disease has progressed following non-steroidal aromatase inhibitor therapy. Entinostat is an investigational histone deacetylase inhibitor (HDACi) set to begin Phase 3 testing in combination with exemestane in postmenopausal women with metastatic ER+ breast cancer who have progressed on hormonal therapy.

The Breakthrough Therapy designation for entinostat is based on data from the completed Phase 2 ENCORE 301 study, in which entinostat was shown to extend both progression-free survival and overall survival when added to exemestane in postmenopausal women with ER+ metastatic breast cancer whose cancer had progressed after treatment with a nonsteroidal aromatase inhibitor and with a very acceptable tolerability profile. A Phase 3 trial, planned to begin enrolling patients in the first quarter of 2014 is currently being developed by the ECOG-ACRIN Cancer Research Group, which would conduct the study under the sponsorship of the Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI).

"The FDA's decision to designate entinostat a Breakthrough Therapy is important validation of the drug's therapeutic potential in women with advanced breast cancer," said Arlene M. Morris, Syndax's chief executive officer. "Currently, women with ER+ breast cancer who have progressed on hormonal therapy have limited therapeutic options. Entinostat's epigenetic mechanism may reverse resistance to hormonal therapy, delaying the need for toxic chemotherapeutic agents and improving survival when given in combination with a
'/>"/>

SOURCE Syndax Pharmaceuticals Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Syndax and Eddingpharm Enter into a License Agreement Giving Eddingpharm Rights to Commercialize Entinostat in China and Other Asian Countries
2. Syndax Pharmaceuticals Announces Publication of Clinical Study Demonstrating that Entinostat Targets Resistance Pathways in Breast Cancer
3. Syndax Pharmaceuticals to Present Updated Overall Survival Data With Entinostat in Metastatic Breast Cancer at ASCO
4. NextDocs Receives $13.5 Million in Funding to Fuel Expansion
5. TWi Biotechnology Receives Patent Allowance for Its Lead Drug Candidate AC-201 in the United States
6. Unique New PIR Knee System Receives CE Mark
7. EECP Therapy Receives Class lla Recommendation in European Society of Cardiology Guidelines for the Management of Stable Coronary Artery Disease
8. Mylan Acquisition of Agila Receives Approval from Indias Foreign Investment Promotion Board and Cabinet Committee on Economic Affairs
9. Halozyme Announces Roche Receives Marketing Authorization for Herceptin SC in European Union
10. HeartWare Receives FDA Approval To Enroll Supplemental Patient Cohort In Destination Therapy Trial
11. Magellan Diagnostics Receives FDA Clearance for LeadCare Ultra Bench-top Clinical Lead Analyzer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/29/2014)... York , July 29, 2014 ... Transparency Market Research "Surgical Navigation Systems Market (Neurosurgical Navigation ... Global Industry Analysis, Size, Share, Growth, Trends and Forecast, ... was valued at USD 218.5 million in 2013 and ... from 2014 to 2020, to reach an estimated value ...
(Date:7/29/2014)... LAUDERDALE, Fla. , July 29, 2014 /PRNewswire-iReach/ ... medical service provider, has launched its Medical ... Program.  These services are tailored to the ... excellent standards prompted industry operators to propose that ... MHG Medical,s new program is intended to ...
(Date:7/29/2014)... BEDFORD, Mass. , July 29, 2014  Instrumentation Laboratory ... identity, including a new corporate logo. This is part of ... IL. Founded in Boston, MA ... Group family of companies since 1992.  Other companies in the ... ), Biokit and Systelab ( Barcelona, Spain ).  ...
Breaking Medicine Technology:Surgical Navigation Systems Market Expected to Reach USD 295.5 Million Globally in 2020: Transparency Market Research 2Surgical Navigation Systems Market Expected to Reach USD 295.5 Million Globally in 2020: Transparency Market Research 3Surgical Navigation Systems Market Expected to Reach USD 295.5 Million Globally in 2020: Transparency Market Research 4MHG Medical Management Services Aims to Change Cruise Industry Standard With New Equipment Maintenance Program 2Instrumentation Laboratory Unveils New Corporate Brand 2Instrumentation Laboratory Unveils New Corporate Brand 3
(Date:7/29/2014)... 2014 The Natural Multiple Sclerosis Treatment ... story to Gary M. Levin’s cure program. , ... for this serious disorder. Levin says that multiple sclerosis ... can be found in patients. , Dr. Gary ... many years, Levin has worked with patients suffering from ...
(Date:7/29/2014)... Winter is here down under, and ... Sydney’s central business district. That is, until a troop ... the otherwise ordinary day into a celebration—a celebration of ... advocates of The Truth About Drugs, a drug prevention ... They woke up the city with a rousing performance ...
(Date:7/29/2014)... Denver, Colorado (PRWEB) July 29, 2014 Daily ... is a 5 step holistic system that will permanently eliminate ... to Thomas Coleman his natural treatment will banish symptoms such ... ringing or beeping sound heard by patients will be gone ... 30 to 60 days. The author of this program says ...
(Date:7/29/2014)... July 29, 2014 (HealthDay News) --,The time at which ... their chances for survival, new research suggests. Showing ... or during holidays is associated with a 13 percent ... hours, researchers report. Every year, more than 250,000 ... severe type of heart attack, which is caused by ...
(Date:7/29/2014)... Although the bite of a brown recluse spider is ... an expert notes. It,s still important to recognize ... brown recluse spider bite, warned Dr. Donna Seger, medical ... potentially dangerous bites are on the rise. "As ... The [bite] has classic characteristics, but if physicians are ...
Breaking Medicine News(10 mins):Health News:Natural Multiple Sclerosis Treatment Review Reveals the Inside Story to Gary M. Levin’s Cure Program 2Health News:Sydney Business District “Rocked” by The Truth About Drugs 2Health News:Tinnitus Miracle Review Exposes the Only Holistic System for Tinnitus Cure 2Health News:Heart Attack Patients Treated at Night, Weekends May Have Worse Outcomes 2Health News:Brown Recluse Spider Bites on the Rise, Expert Warns 2
... HealthDay Reporter , THURSDAY, Oct. 27 (HealthDay News) ... speech therapy after suffering a massive stroke at the age ... a year-and-a-half completely isolated, unable to communicate, socialize or work ... in Texas, one of a handful of organizations cropping up ...
... , THURSDAY, Oct. 27 (HealthDay News) -- Nipple-sparing ... patients and women who have their breasts removed because ... a new study. For both groups of women, ... feeling reconstructed breast compared to other types of mastectomy, ...
... By Ellin Holohan HealthDay Reporter , ... a lifetime of problems after suffering head injuries from ... new study. From communication deficits to trouble with ... injuries can lead to "substantial long-term reduction" in quality ...
... Whitehead Institute scientists have determined that master transcription factors ... this way, signaling pathways are targeted to genes that ... gene expression to control cell state, growth, differentiation, and ... operate properly, a cell receives instructions from its neighbors ...
... of Nursing (NYUCN) received a two-year, $299,990.00 grant from ... (NCSBN) to research the "Impact of an Internationally Educated ... Nursing Homes." According to the Principal Investigator, Laura ... the NCSBN,s Patient Safety, Practice (LPN/VN, RN), and International ...
... By Maureen Salamon HealthDay Reporter , THURSDAY, Oct. 27 ... its frequent companion, drinking, may be as well, a new study ... week find a link between heavy boozing and a rise in ... hand, studies also suggest that heavier people are less likely to ...
Cached Medicine News:Health News:Speech Therapy Key to Stroke Rehab, But Many Miss Out 2Health News:Speech Therapy Key to Stroke Rehab, But Many Miss Out 3Health News:Nipple-Sparing Mastectomies May Be Right for Some 2Health News:Children With Head Injuries Can Face Lifetime of Problems 2Health News:Children With Head Injuries Can Face Lifetime of Problems 3Health News:How major signaling pathways are wired to our genome gives new insight into disease processes 2Health News:How major signaling pathways are wired to our genome gives new insight into disease processes 3Health News:Too Much Drinking May Raise Lung Cancer Risk: Study 2Health News:Too Much Drinking May Raise Lung Cancer Risk: Study 3
200 L, Racked, Pre-sterilized, 96 tips/rack, clear Recommended for 20, 25, 50, 100 and 200 L pipettes. Can also be used with 300 L pipettes when pipetting 200 L or less....
... Finntips have been designed to optimize the ... of our tip products is widely recognized ... range has been extended over the years ... standard and special tips including filter tips, ...
MBP's 200 L large orifice tip is perfect for handling fragile cells, viscous samples and genomic....
Designed to fit the Brinkmann Tranferpette and Treff Multi-Channel 300 L Pipettors, this tip provides extra space for repeat pipetting....
Medicine Products: