Navigation Links
Pharmacyclics Announces Third Breakthrough Therapy Designation for Ibrutinib from the U.S. Food and Drug Administration
Date:4/8/2013

ents with deletion 17p.

The FDA Breakthrough Therapy Designation for ibrutinib in CLL patients with deletion 17p was based on data from pre-clinical and clinical studies where ibrutinib as a monotherapy was used to treat patients with this disease. Ibrutinib has the potential to improve the outcome in this serious and life-threatening disease which has a poor prognosis. In addition, Pharmacyclics and Janssen have recently initiated a Phase II study of ibrutinib in patients with CLL deletion 17p, RESONATE™ -17, which is a single-arm, open-label, multi-center trial using ibrutinib as a monotherapy in patients who have deletion 17p and who did not respond to or relapsed after at least one prior CLL treatment (a high unmet need population). The primary endpoint of the study will be overall response rate. This global study opened this year and Pharmacyclics plans to enroll 111 patients worldwide.

About Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia (CLL) is a slow-growing blood cancer that starts in the white blood cells (lymphocytes), most commonly from B-cells. CLL is the second most common adult leukemia. Approximately 16,000 patients in the US are diagnosed each year with CLL. The prevalence of CLL is approximately 113,000 in the US. The disease is a chronic disease of the elderly with an average survival of about 5 years. Patients commonly receive multiple lines of treatment over the course of their disease.

In CLL the genetic mutation 17p deletion occurs when the short arm of chromosome 17 is missing.  Del 17p is associated with abnormalities of a key tumor suppressor gene, TP53, which results in poor response to chemoimmunotherapy and worse treatment outcomes. It occurs in about 7% of treatment naive CLL patients and is estimated to be approximately 20% to 40% of relapsed or refractory patients harboring the mutation.  

About Ibrutinib

Janssen Biotech, Inc. and Pharmacyclics entered a col
'/>"/>

SOURCE Pharmacyclics, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Pharmacyclics, Inc. Prices Public Offering of Common Stock
2. Pharmacyclics, Inc. Announces Proposed Public Offering of Common Stock
3. Pharmacyclics First to Announce Breakthrough Therapy Designation in Oncology from the U.S. Food and Drug Administration
4. Pharmacyclics Announces Date of Financial Results for Three and Six Months Ended December 31, 2012 and Conference Call
5. Pharmacyclics Reports Fourth Quarter and Full Year Fiscal 2012 Financial Results and Recent Developments
6. Pharmacyclics Announces Oral Presentations of Ibrutinib (PCI-32765) at the 17th Congress of the European Hematology Association
7. Pharmacyclics Announces Oral Presentations and Clinical Update of Ibrutinib (PCI-32765) at the 2012 Annual Meeting of the American Society of Clinical Oncology
8. scPharmaceuticals LLC Announces Strategic Partnership with Sensile Medical to Develop Novel Heart Failure Treatment Aimed to Reduce Readmission Rates
9. Hanger, Inc. Announces First Quarter 2013 Earnings Release And Conference Call
10. Sigma-Aldrich Announces Q1 2013 Earnings Conference Call
11. Uroplasty Announces CEO Resignation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2015)... Ala. , Aug. 27, 2015 /PRNewswire/ ... Outpatient Pharmacy Provider (IOPP™) is expanding its ... of a medication-focused transition of care program ... named "RxCare Management," provides hospitals with technology ... hospital performance measures that have been mandated ...
(Date:8/27/2015)... , Aug. 27, 2015  A mere one ... Booz Allen Hamilton . A new white ... development inefficiencies are impeding and disrupting manufacturers, success. ... Waste and Improve Value In Product Development Processes ... inaccessible data and how it affects the product development ...
(Date:8/27/2015)... NorthStar Anesthesia , one of the country,s ... selected by Mercy, based in Toledo, Ohio ... hospitals:  Mercy St. Vincent  Medical Center and Mercy St. ... St. Charles  Hospital in Oregon and ... "As we looked to create a more ...
Breaking Medicine Technology:Rx Care Management by Proxsys Rx - Transition of Care Technology Helps Prevent Hospital Medication Errors 2New White Paper Reveals How Manufacturers Can Improve Product Development Processes 2Four Mercy Hospitals in Northwest Ohio Select NorthStar Anesthesia 2
... Medical Inc. (OTC Bulletin Board: PUMD ), ... signing of an agreement for $3.125 million in equity ...  The proceeds of the financing will be used to ... activities associated with final preparation, manufacturing and eventual marketing ...
... ... if (typeof(lpUnit)==,undefined,) var ... var shortURL = ""; BitlyCB.alertResponse = function(data) ... grab the first one. for (var r in data.results) { first_result = data.results[r]; break; } for (var ...
Cached Medicine Technology:UPDATE - ProUroCare Announces $3 Million Financing Agreement 2UPDATE - ProUroCare Announces $3 Million Financing Agreement 3Transcept Pharmaceuticals to Present at BIO Investor Forum 2Transcept Pharmaceuticals to Present at BIO Investor Forum 3Transcept Pharmaceuticals to Present at BIO Investor Forum 4Transcept Pharmaceuticals to Present at BIO Investor Forum 5Transcept Pharmaceuticals to Present at BIO Investor Forum 6Transcept Pharmaceuticals to Present at BIO Investor Forum 7
(Date:8/27/2015)... ... 27, 2015 , ... Florida Hospital North Pinellas, located at 1395 South Pinellas Avenue in Tarpon ... The new facility will be located at US Highway 19 North and Highlands Boulevard, less ... 18, and work on the project is slated to begin in September 2015. ...
(Date:8/27/2015)... ... August 27, 2015 , ... Sunbelt® Bakery, maker of ... corn syrup, is changing the expectation of how protein bars should taste with the ... unlike any other protein bar on the market today. , The new Protein ...
(Date:8/27/2015)... (PRWEB) , ... August 27, 2015 , ... ... technologies and development solutions for drugs, biologics and consumer health products, today announced ... the upcoming FlyPharma Conference, to be held at the Radisson Blu Edwardian Hotel, ...
(Date:8/27/2015)... ... August 27, 2015 , ... ... publishers and companies leverage key operational, technical, business and human assets, has ... Media Group, Inc., will provide VIVO related services such as strategic evaluation, ...
(Date:8/27/2015)... ... 27, 2015 , ... Today, Centigon Solutions, a leading provider ... analytics designer for SAP Lumira. , First of its kind, CMaps Analytics Designer ... the cloud and export native extensions for SAP Lumira. The resulting Location Analytics ...
Breaking Medicine News(10 mins):Health News:Florida Hospital North Pinellas is Opening a New Free-Standing Emergency Room in Palm Harbor 2Health News:Florida Hospital North Pinellas is Opening a New Free-Standing Emergency Room in Palm Harbor 3Health News:Sunbelt® Bakery Changes the Expectations of How Protein Bars Should Taste with the Introduction of Its New Protein Delights 2Health News:Sunbelt® Bakery Changes the Expectations of How Protein Bars Should Taste with the Introduction of Its New Protein Delights 3Health News:Clinical Trial Supply Chain Logistics to be Discussed By Catalent Expert at Upcoming Flypharma Conference 2Health News:DuraSpace Selects Gunter Media Group, Inc. as a Registered Service Provider for VIVO 2Health News:DuraSpace Selects Gunter Media Group, Inc. as a Registered Service Provider for VIVO 3Health News:CMaps Analytics Announces New Location Intelligence Integration for SAP Lumira 2
... EMT among winners with inspirational, ... educational stories, ... in partnership with Procter & Gamble Pharmaceuticals (P&G), has,selected seven winners ... educate and inspire those affected by ulcerative,colitis. Winners, stories reflect a ...
... and revises Press Release from May 1st, 2008. Correction limited ... to the time of presentation.], ... scheduled to present at the Bank of America 2008 Health,Care Conference at ... Joseph W. Kaufmann, Kensey Nash,s President & CEO, will deliver the,Company,s presentation, ...
... affordable source of carbon that can sustain future economic ... recognised. It is also apparent that the increasingly high ... , The Plant Journal is pleased to present a ... plants can or could use to convert their fixed ...
... Awareness Month; LIFE Foundation Reviews Common, Misconceptions to Encourage People to Evaluate ... ... ARLINGTON, Va., May 12 If you were unable to work,because ... of a new survey released today by the nonprofit,LIFE Foundation show that ...
... Inc., found to have committed patent and ... ... (Nasdaq: MTEX ) a leading developer and provider of ... court,jury in the Northern District of Texas found that Glycoproducts,International ...
... Laser System Successfully Assists Removal of 975 Cardiac ... ... Leads, COLORADO SPRINGS, Colo., May 12 Spectranetics,Corporation (Nasdaq: ... excimer laser sheath safely and effectively,assists removal of pacing and ...
Cached Medicine News:Health News:UPDATE: Celebrating UC Success Announces Essay Contest Winners 2Health News:UPDATE: Celebrating UC Success Announces Essay Contest Winners 3Health News:UPDATE: Celebrating UC Success Announces Essay Contest Winners 4Health News:UPDATE: Celebrating UC Success Announces Essay Contest Winners 5Health News:UPDATE: Celebrating UC Success Announces Essay Contest Winners 6Health News:Corrected Press Release: Kensey Nash to Present at the Bank of America 2008 Health Care Conference 2Health News:Beyond nutrition -- plants deliver 2Health News:New Survey Finds Overwhelming Majority of Working Americans Not Financially Prepared for Disability, Would Rely on Sources Other than Themselves for Support 2Health News:New Survey Finds Overwhelming Majority of Working Americans Not Financially Prepared for Disability, Would Rely on Sources Other than Themselves for Support 3Health News:New Survey Finds Overwhelming Majority of Working Americans Not Financially Prepared for Disability, Would Rely on Sources Other than Themselves for Support 4Health News:Jury Validates Key Mannatech Technology Patents Involving Its Ambrotose(R) Glyconutrient Products 2Health News:Jury Validates Key Mannatech Technology Patents Involving Its Ambrotose(R) Glyconutrient Products 3Health News:Safe Options for Cardiac Lead Removal: Study Published in Heart Rhythm Journal 2Health News:Safe Options for Cardiac Lead Removal: Study Published in Heart Rhythm Journal 3
The reliable and easy-to-use 3900/P pulse oximeter is now more advanced - featuring TruTrak+ technology, the proprietary clinical motion algorithm from Datex+-Ohmeda....
The reliable and easy-to-use 3800 pulse oximeter is now more advanced - featuring TruTrak+ technology, the proprietary clinical motion algorithm from Datex+-Ohmeda....
... can operate in two additional modes. The ... creating a fully featured handheld pulse oximeter, ... used to upgrade existing equipment through the ... or software upgrades to improve the performance ...
... The stylish Avant® 9600s simple functionality, ... of memory makes it well-suited for ... proven digital pulse oximetry, the Avant ... rugged durability. The 9600 provides a ...
Medicine Products: