Navigation Links
Independent Data Monitoring Committee Recommends Early Stopping of Phase 3 Study of Ibrutinib in Relapsed/Refractory CLL/SLL Patients Based on a Planned Interim Analysis
Date:1/7/2014

observed. The IDMC agreed that these results suggest evidence of clinical benefit as well as a tolerable safety profile in patients receiving ibrutinib as compared to intravenous doses of ofatumumab. The IDMC also recommended that the sponsor provide access to ibrutinib to patients in the ofatumumab arm. 

These results will be presented at an upcoming medical meeting and also will be submitted for publication in a peer-reviewed journal.

About Ibrutinib (IMBRUVICA™)

Ibrutinib was approved in November 2013 in the U.S. under the tradename IMBRUVICA™, as a single agent for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is based on overall response rate. An improvement in survival or disease-related symptoms has not been established.   

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage – Five percent (5%) of patients with MCL had Grade 3 or higher bleeding events (subdural hematoma, gastrointestinal bleeding, and hematuria). Bleeding events including bruising of any grade occurred in 48% of patients with MCL treated with 560 mg daily. The mechanism for the bleeding events is not well understood. Consider the benefit-risk of ibrutinib in patients requiring antiplatelet or anticoagulant therapies and the benefit-risk of withholding ibrutinib for at least 3 to 7 days pre and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections – Fatal and non-fatal infections have occurred. At least 25% of patients with MCL had infections greater than or equal to Grade 3, according to NCI Common Terminology Criteria for Adverse Events (CTCAE). Monitor patients for fever and infections and evaluate promptly.

Myelosuppression – Treatment-emergent Grade 3 or 4 cytopenias were reported in 41% of patients. These included neutropenia (29%), th
'/>"/>

SOURCE Janssen Research & Development, LLC
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Hologic Expands its Board of Directors with Appointment of Two Independent Directors and Engages Chairman of Mt. Sinai Radiology Department as Scientific Advisor
2. Actinium Pharmaceuticals Appoints Richard Steinhart As New Independent Director
3. Leica Biosystems Launches Independently* Qualified Menu of IHC Antibodies for Hematopathology
4. American Pacific Board Continues Focus On Corporate Governance With Appointment Of Independent Lead Director
5. Independent Pharmacy Cooperative to Distribute Promescent, Topical Medication for Premature Ejaculation
6. Intarcia Supports American Diabetes Association Call For Independent Review Of Incretin-Based Therapies
7. Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company Statement on the ADA Request for Independent Review of Incretin-Based Therapies
8. Managed Health Care Associates, Inc. (MHA) Released Results of Sixth Annual Independent Long Term Care Member Study with Expanded Specialty Pharmacy Findings
9. Agnitio Launches Rainmaker One to Remove the Complexity of Managing Independent Apps
10. Independent Drugstore Lobby Wants Sweeping Antitrust Exemptions to Charge Higher Prescription Drug Prices
11. Independent Study Published in Clinical Infectious Diseases Highlights the Importance of Antimicrobial Removal Systems in Blood Culture to Rapidly and Accurately Aid in the Diagnosis of Sepsis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... , Jan. 15, 2014  A novel wearable injector slightly larger ... painless for patients to self-inject prescription drugs in the large ... cancer, blood diseases, autoimmune deficiencies, and genetic disorders.  ... to $220B by 2018, according to analysts.   Many of these ...
(Date:1/14/2014)... Jan. 14, 2014 Dynamic Healthcare Services, Inc. ("DHS"), a ... it acquired Progressive Home Medical Equipment, Inc. ("Progressive") of ... terms of the acquisition were not disclosed. ... providing a wide range of sleep, mobility, and respiratory products ...
(Date:1/14/2014)... N.Y. , Jan. 14, 2014   Oligomerix, Inc. , ... modifying therapeutics for Alzheimer,s disease (AD) and related neurodegenerative ... to Valhalla, NY as of ... laboratory space at New York Medical College. ...
Breaking Medicine Technology:Enable Injections Presents A New Class of Injectors for Drug Delivery at PEPTalk, Drug Delivery Partnership Meetings 2Dynamic Healthcare Services Completes Progressive Home Medical Equipment of Clarion, PA Investment 2Dynamic Healthcare Services Completes Progressive Home Medical Equipment of Clarion, PA Investment 3Oligomerix Relocates Corporate Headquarters and Secures Additional Laboratory Space from New York Medical College 2
... Mich., Nov. 3, 2011 Citing an increased need ... diabetes threat, Meijer has launched a chain-wide effort to ... training more than 200 pharmacists as diabetes specialists, announced ... Mich.-based supercenter, today. "A community pharmacist is ...
... Allscripts Healthcare Solutions, Inc. (Allscripts – NASDAQ: ... months ended September 30, 2011. (Logo:   http://photos.prnewswire.com/prnh/20100901/CG58147LOGO ... Bookings of $266.8 million, compared to $198.6 million ... increase GAAP revenue of $368.8 million; non-GAAP revenue ...
Cached Medicine Technology:Meijer Launches Diabetes Education Initiative in All 197 Pharmacies, Trains More Than 200 Pharmacists to Be Diabetes Specialists 2Meijer Launches Diabetes Education Initiative in All 197 Pharmacies, Trains More Than 200 Pharmacists to Be Diabetes Specialists 3Allscripts Reports Third Quarter 2011 Results 2Allscripts Reports Third Quarter 2011 Results 3Allscripts Reports Third Quarter 2011 Results 4Allscripts Reports Third Quarter 2011 Results 5Allscripts Reports Third Quarter 2011 Results 6Allscripts Reports Third Quarter 2011 Results 7Allscripts Reports Third Quarter 2011 Results 8Allscripts Reports Third Quarter 2011 Results 9Allscripts Reports Third Quarter 2011 Results 10Allscripts Reports Third Quarter 2011 Results 11Allscripts Reports Third Quarter 2011 Results 12Allscripts Reports Third Quarter 2011 Results 13Allscripts Reports Third Quarter 2011 Results 14Allscripts Reports Third Quarter 2011 Results 15Allscripts Reports Third Quarter 2011 Results 16
(Date:4/17/2014)... presence of chronic inflammation in benign prostate tissue ... and this association was found even in those ... a study published in Cancer Epidemiology, Biomarkers ... Association for Cancer Research. , An analysis of ... the placebo arm of the Prostate Cancer Prevention ...
(Date:4/17/2014)... study published today in PLOS Pathogens , children ... is common can mount an immune response to infection ... repeated bouts of high fever and illness and partially ... The findings may help researchers develop future interventions that ... parasite. , Each year, approximately 200 million cases of ...
(Date:4/17/2014)... Le Bonheur Children,s Hospital Pediatrician-in-Chief Jon McCullers, MD, ... the April issue of Nature Reviews Microbiology ... Dr. McCullers, a world-renowned infectious disease specialist, ... the University of Tennessee Health Science Center, analyzed ... 1918, 1957 and 1968 pandemics, as well as ...
(Date:4/17/2014)... (April 16, 2014) The cause of neuronal death ... study proposes that neurons may be mistaken for foreign ... similar to the way autoimmune diseases like type I ... cells. The study was published April 16, 2014, in ... and likely controversial, idea in Parkinson,s disease; but if ...
(Date:4/17/2014)... An international team led by researchers at UC Davis ... plays a key role in cell division, also boosts ... the first time the complex has been shown to ... B1/Cdk1 an excellent target to control cellular energy production, ... was published online today in the journal Developmental ...
Breaking Medicine News(10 mins):Health News:Chronic inflammation may be linked to aggressive prostate cancer 2Health News:Chronic inflammation may be linked to aggressive prostate cancer 3Health News:Study sheds light on how the immune system protects children from malaria 2Health News:Is Parkinson's an autoimmune disease? 2Health News:Dual role: Key cell division proteins also power up mitochondria 2
... of decline over past decade , , MONDAY, Oct. 15 (HealthDay ... across the United States, offering what an expert called a ... a new report, cancer death rates fell by 2.1 percent ... 1.1 percent annual decline recorded between 1993 and 2003. , ...
... 15, 2007 Post-hoc and other analyses of secondary ... Shire plc,s (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) ulcerative ... LIALDA in patients with mild to moderate ulcerative colitis. ... III, open-label 12-14 month extension study, are being presented ...
... LOGAN, Utah, Oct. 15 Facet Solutions, Inc. ... on the first cohort of,patients to receive its ... these patients at one year include a significant,decline ... function; and no,post-operative complications. Additionally, the first patient ...
... Patients with obstructive sleep apnea (OSA) who also ... continuous positive airway pressure (CPAP) relieves them of symptoms ... October 15 issue of the Journal of Clinical Sleep ... Sleep Center at Universitys Community Hospital in Tampa, Fla., ...
... schedules now routine and,the initial excitement over, lunches will ... a good time to re-evaluate menus and discuss healthier,choices ... The following are suggestions from the experts at ... nutritional impact. Add a,handful of trail mix and fresh ...
... have on average a 71 percent lower chance of ... lowest-rated hospitals across 18 procedures and conditions analyzed in ... issued today by HealthGrades, the healthcare ratings company. The ... of care between the highest-performing hospitals and all others, ...
Cached Medicine News:Health News:U.S. Cancer Death Rate Continues to Fall 2Health News:U.S. Cancer Death Rate Continues to Fall 3Health News:New Analyses of long-term LIALDA (mesalamine) data presented at ACG 2Health News:New Analyses of long-term LIALDA (mesalamine) data presented at ACG 3Health News:New Analyses of long-term LIALDA (mesalamine) data presented at ACG 4Health News:Facet Solution's AFRS(TM) Implant Demonstrates Positive Clinical Results After One Year Follow Up 2Health News:Fresh, Tasty - Healthy - Lunch and Snack Ideas 2Health News:Mortality rates 71 percent lower at top-rated hospitals: HealthGrades 2008 hospital-quality study 2Health News:Mortality rates 71 percent lower at top-rated hospitals: HealthGrades 2008 hospital-quality study 3
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: