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:4/23/2015)... Inc. (NYSE: RMD ) today announced results for ... quarter was $422.5 million, a 6 percent increase compared ... percent increase on a constant currency basis).  Net income ... to the quarter ended March 31, 2014.  Diluted earnings ... of 2 percent compared to the quarter ended March ...
(Date:4/23/2015)... 23, 2015  Jazz Pharmaceuticals plc (Nasdaq: JAZZ ... first quarter financial results on Thursday, May 7, 2015, ... will host a live audio webcast immediately following the ... first quarter 2015 financial results and provide a business ... the live audio webcast via the Investors & Media ...
(Date:4/23/2015)... 2015 Surna, Inc. (OTCQB: SRNA), a technology ... equipment and systems for controlled environment agriculture ("CEA") ... will host a shareholder conference call to discuss ... 4:15 PM Eastern Standard Time/1:15 PM Pacific Standard ... be listen-in only, but will include a Q&A ...
Breaking Medicine Technology:ResMed Inc. Announces Results for the Third Quarter of Fiscal Year 2015 2ResMed Inc. Announces Results for the Third Quarter of Fiscal Year 2015 3ResMed Inc. Announces Results for the Third Quarter of Fiscal Year 2015 4ResMed Inc. Announces Results for the Third Quarter of Fiscal Year 2015 5ResMed Inc. Announces Results for the Third Quarter of Fiscal Year 2015 6ResMed Inc. Announces Results for the Third Quarter of Fiscal Year 2015 7ResMed Inc. Announces Results for the Third Quarter of Fiscal Year 2015 8ResMed Inc. Announces Results for the Third Quarter of Fiscal Year 2015 9ResMed Inc. Announces Results for the Third Quarter of Fiscal Year 2015 10ResMed Inc. Announces Results for the Third Quarter of Fiscal Year 2015 11ResMed Inc. Announces Results for the Third Quarter of Fiscal Year 2015 12ResMed Inc. Announces Results for the Third Quarter of Fiscal Year 2015 13Jazz Pharmaceuticals to Report 2015 First Quarter Financial Results on May 7, 2015 2Surna, Inc. Announces Shareholder Conference Call 2Surna, Inc. Announces Shareholder Conference Call 3
... online marketplace for medical equipment , is pleased ... a comparison feature that allows buyers to select as ... them in making the best buying decision. Once the ... chart is automatically generated, making it simple to view ...
... N.J., Sept. 1 QRxPharma (ASX: QRX and OTCQX: ... final MoxDuo IR pivotal Phase 3 study required for ... planned sample size of 140 patients has greater than ... there is no need to enrol additional patients. QRxPharma ...
Cached Medicine Technology:MedWOW Adds Comparison Tool for Shoppers' Medical Equipment - Offers eBook Free to New Registrants 2QRxPharma Announces Interim Analysis of Final Pivotal Phase 3 Study for MoxDuo®IR 2QRxPharma Announces Interim Analysis of Final Pivotal Phase 3 Study for MoxDuo®IR 3
(Date:4/25/2015)... 25, 2015 In the United States ... above needed treatment for an illicit drug ... Abuse and Mental Health Services Administration’s Survey on Drug ... alarming numbers are harrowing stories of men and women ... . David H. Kerr , founder and retired ...
(Date:4/25/2015)... NV (PRWEB) April 25, 2015 The ... is still eliciting the excitement of the public and ... into the months of May and June. From ... held their biannual tradition of "Special Prayers." More than ... had attended previous Special Prayers and have reported intense ...
(Date:4/25/2015)... April 25, 2015 The URO CENTER of ... has been chosen by the New York Academy of Medicine ... medicine in the field of Urology. , Dr. Ferdinand Valentine, ... speciality, Genito-Urinary diseases. He was a man of rare ... of urology. Not only did he devote his life ...
(Date:4/24/2015)... Bird B Gone, the leader in bird control products ... line of bird control solutions to address the growing threat ... Threaten Pacific, Central and Mississippi Farms , According to an ... of highly pathogenic avian flus in the Pacific, Central and ... wild birds enter poultry farms. The USDA urges farmers to ...
(Date:4/24/2015)... 2015 Ryadon is a leading manufacturer ... capabilities and services to complement any custom hardware requirements ... Program will be offered on all heavy duty drawer ... Receive 10% discount - Order 20+: Receive 20% discount ... Slides Products, Furniture ,Drawer ...
Breaking Medicine News(10 mins):Health News:New Book Features Powerful Stories of People Who Overcame Addiction 2Health News:New Book Features Powerful Stories of People Who Overcame Addiction 3Health News:Trivedi Master Wellness™ Announces the Resounding Success of their Special Prayers Human Wellness Program 2Health News:Trivedi Master Wellness™ Announces the Resounding Success of their Special Prayers Human Wellness Program 3Health News:The 2015 Valentine Award Comes From The Heart and Goes To Famous New York Urologist 2Health News:The 2015 Valentine Award Comes From The Heart and Goes To Famous New York Urologist 3Health News:Bird B Gone Offers Solutions to Bird Flu Threat to Poultry Farms 2Health News:Bird B Gone Offers Solutions to Bird Flu Threat to Poultry Farms 3Health News:Bird B Gone Offers Solutions to Bird Flu Threat to Poultry Farms 4Health News:Ryadon Inc. Offers Quantity Drawer Slide Discount Program Nationwide in May 2015 2Health News:Ryadon Inc. Offers Quantity Drawer Slide Discount Program Nationwide in May 2015 3
... disease through causing inflammation of the arteries. There is mounting evidence ... new study uncovers a link between the mouth and the heart ... Buffalo find that people with gum disease have higher than normal ... enter the circulation via the gums, and then trigger the liver ...
... way of treating tissue at the back of the mouth is ... 30 per cent of women have a problem with snoring - ... in the soft palate - the area of tissue at the ... tonsils, and the base of the tongue. Surgery that makes this ...
... disease also improves the paralysis experienced by stroke survivors.,Levodopa ... and this may help brain cells involved in controlling ... treatment in Parkinson's disease, but a new trial suggests ... ,// ,Researchers at the Bad Aibling Neurological ...
... Researchers at the University of Pittsburgh School of Medicine ... women's concerns about weight is the first treatment to ... for weight-concerned women assumed that the best approach to ... weight gain after they quit smoking. This study, as ...
... influence the risk of oesophagal cancer. ,A family in Liverpool, ... the genetic basis of cancer of the oesophagus. Twenty one ... five generations. The disease affects those who also have a ... researchers are studying 350 members of the extended Liverpool family. ...
... who eat the healthiest diets also eat a lot of ... Index (HEI) is a measure that US nutritionists have developed ... eating pattern rather than intake of specific nutrients. You get ... milk or meat, ten more possible points for dietary limitations ...
Cached Medicine News:Health News:Stop smoking and reduce weight 2
Mounted on a fully adjustable molded,headband with crown strap and comfort,cushions, the sturdy Halogen III Classic is,lightweight, comfortable and durable....
Mounted on a sturdy, molded headband,the Classic has a fully adjustable crown,strap and cushioning that adds to,your comfort....
... ICON DS Strep A is a qualitative ... from throat swabs. The ICON DS Strep A ... especially in rare and low positive colonization samples. ... format. With outstanding performance, ICON DS Strep A ...
... The Inverness Medical Ovulation Test Kits help ... five ovulation predictor sticks to help you predict ... The tests quickly and accurately detect the increase ... which normally occurs 24 to 48 hours before ...
Medicine Products: