Navigation Links
Ibrutinib Expanded Access Program Open to Eligible U.S. Patients with Relapsed or Refractory Mantle Cell Lymphoma
Date:5/6/2013

RARITAN, N.J., May 6, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced patients are now enrolling in a multicenter, open-label expanded access program (EAP) in the United States for the investigational oral Bruton's Tyrosine Kinase (BTK) inhibitor ibrutinib, which is being jointly developed by Janssen and Pharmacyclics, Inc. Several EAP sites are in the process of opening the clinical trial and information about the program is posted on clinicaltrials.gov (NCT01833039). The mantle cell lymphoma (MCL) EAP is available to eligible patients with relapsed or refractory MCL, who could benefit from treatment with ibrutinib prior to U.S. Food and Drug Administration (FDA) approval.

Interested patients with MCL should discuss the option of accessing ibrutinib through the EAP with their physician to understand if this is an appropriate option for them.

"We recognize there are immediate medical needs of certain individuals with relapsed or refractory MCL," said Peter F. Lebowitz , M.D., Ph.D., Global Oncology Head, Janssen. "Now that the ongoing U.S. clinical studies in relapsed or refractory MCL have completed enrollment, the expanded access protocol provides that opportunity."

The ibrutinib expanded access program was agreed upon in collaboration with the FDA as part of ibrutinib's breakthrough therapy designation for relapsed/refractory MCL granted by the FDA in February 2013. EAPs are allowed by the FDA under certain circumstances even though the safety and effectiveness of the drug have not been fully established. Expanded access programs provide a mechanism for early access to an investigational drug in the pre-approval period to treat patients with a serious or immediately life-threatening disease or condition that has no comparable or satisfactory alternative treatment options.[1]

About the
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Pharmacyclics Announces Oral Presentations and Clinical Update of Ibrutinib (PCI-32765) at the 2012 Annual Meeting of the American Society of Clinical Oncology
2. Pharmacyclics Announces Oral Presentations of Ibrutinib (PCI-32765) at the 17th Congress of the European Hematology Association
3. Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, Suggest High and Durable Responses in Relapsed/Refractory Mantle Cell Lymphoma
4. Follow-up Results of Phase 2 Study of Investigational Agent, Ibrutinib, in Relapsed/Refractory Mantle Cell Lymphoma Presented at American Society of Hematology Annual Meeting
5. Ibrutinib Receives Two Oncology Breakthrough Therapy Designations from U.S. Food and Drug Administration
6. Pharmacyclics Announces Third Breakthrough Therapy Designation for Ibrutinib from the U.S. Food and Drug Administration
7. Phase II Ibrutinib Monotherapy Study Shows CLL Patients Achieved Rapid and Sustainable Disease Control Irrespective of Age or High Risk Prognostic Factor
8. Delcath To Offer Second Generation Hemofiltration Cartridge In U.S. Expanded Access Program
9. Boehringer Ingelheim announces afatinib expanded access program (EAP) for patients with EGFR mutation-positive advanced NSCLC
10. Elusys Awarded Additional $14.5 Million Under Existing U.S. Government Contracts Supporting Expanded Human Safety Studies of ETI-204 for Treatment of Inhalational Anthrax
11. CombiMatrix Corporation Selects Cartagenia BENCHlab CNV Platform to Bolster Expanded Lab Operations
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... , July 10, 2014 Integrated Silicon ... in advanced memory and analog IC solutions, today announced ... Thursday, July 24, 2014, at 7:00 a.m. Pacific Time ... results for the fiscal 2014 third quarter ended June ... via telephone, dial 1-888-556-4997 before 6:50 a.m. Pacific time ...
(Date:7/10/2014)... , July 10, 2014  BC Technical, the ... MiE America , Inc., a leading provider of ... into a long-term agreement naming BC Technical as the ... MiE and BC Technical announced today ... to establish BC Technical as the service and systems ...
(Date:7/10/2014)...  Decision Resources Group finds that while more ... are willing to prescribe Durata,s Dalvance (dalbavancin) and ... OPAT, approximately two-thirds of the respondents reported a ... inpatients. However, our findings indicate that nearly two-thirds ... OPAT following hospital discharge, and most are discharged ...
Breaking Medicine Technology:BC Technical Partners With MiE America To Be Authorized Provider Of Systems & Service 2Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 2Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 3
... Resveratrol, Sirtuin1 gene Target Discredited; Lower Dose, Array ... Small Molecules (Longevinex(R)) Exert Greater Effect, SAN ... wine molecule,resveratrol (rez-vair-ah-trawl) has recently attracted scientific and,public ... the effects,of a calorie-restricted diet, the science surrounding ...
... Alpharma Inc.,(NYSE: ALO ), a global ... Phase III pivotal efficacy trial that showed ... capsules provided significant pain relief in patients ... of the hip or knee compared,to placebo. ...
Cached Medicine Technology:Resveratrol Longevity Science Makes Dramatic U-Turn, But Resveratrol Supplements Remain Unchanged 2Resveratrol Longevity Science Makes Dramatic U-Turn, But Resveratrol Supplements Remain Unchanged 3Resveratrol Longevity Science Makes Dramatic U-Turn, But Resveratrol Supplements Remain Unchanged 4Alpharma Announces Positive Results From Pivotal Phase III Efficacy Trial on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules at the American Academy of Pain Management Annual Clinical Meeting 2Alpharma Announces Positive Results From Pivotal Phase III Efficacy Trial on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules at the American Academy of Pain Management Annual Clinical Meeting 3Alpharma Announces Positive Results From Pivotal Phase III Efficacy Trial on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules at the American Academy of Pain Management Annual Clinical Meeting 4Alpharma Announces Positive Results From Pivotal Phase III Efficacy Trial on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules at the American Academy of Pain Management Annual Clinical Meeting 5
(Date:7/12/2014)... Miami, FL (PRWEB) July 12, 2014 Fresh ... Brazil and Colombia will meet on September 5th at ... allowed the world to see some of the brightest stars ... Diehard soccer fans in Miami will be treated to some ... , Brazil is currently ranked as the third best team ...
(Date:7/12/2014)... The report, "Phthalic Anhydride and Derivatives ... Application & Geography – Trends & Forecast to 2018," ... forecasting of market volume and value. The report also ... The market of phthalic anhydride is projected to grow ... million by 2018, with a CAGR of 5.24% from ...
(Date:7/12/2014)... July 12, 2014 ... Peripheral Vascular Devices Market by Angioplasty ... Catheter (IVUS, OCT), IVC Filter (Retrievable), ... 2018" analyzes and studies the major ... the U.S. and Canada. , Browse ...
(Date:7/12/2014)... (PRWEB) July 12, 2014 Demand Response ... with considerable benefits in reducing the imbalance between energy ... grid appliances have been rolled out (due to increasing ... Infrastructure (AMI). This helps in controlling residential appliances and ... growing in the North American region, and with government ...
(Date:7/12/2014)... The fastest-growing mobile technology is LTE (Long Term Evolution). ... continues to grow due to the rapid evolution of ... data traffic, which is a major driver for the ... Measurement equipment comply with industry standards, and services which ... Market is estimated to grown from $3.75 billion in ...
Breaking Medicine News(10 mins):Health News:Brazil Vs. Colombia Tickets Sun Life Stadium: Ticket Down Slashes Ticket Prices for Friendly Match Between Colombia and Brazil 2Health News:Brazil Vs. Colombia Tickets Sun Life Stadium: Ticket Down Slashes Ticket Prices for Friendly Match Between Colombia and Brazil 3Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 2Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 3Health News:Phthalic Anhydride Market Projected to Reach $8.42 Billion by 2018 – Report by MarketsandMarkets 4Health News:North American Interventional Cardiology & Peripheral Vascular Devices Market - New Report by MarketsandMarkets 2Health News:North American Interventional Cardiology & Peripheral Vascular Devices Market - New Report by MarketsandMarkets 3Health News:North American Interventional Cardiology & Peripheral Vascular Devices Market - New Report by MarketsandMarkets 4Health News:North American Interventional Cardiology & Peripheral Vascular Devices Market - New Report by MarketsandMarkets 5Health News:North America Demand Response Management System Worth $12,522.4 Million by 2019 - New Report by MicroMarket Monitor 2Health News:North America Demand Response Management System Worth $12,522.4 Million by 2019 - New Report by MicroMarket Monitor 3Health News:North America Demand Response Management System Worth $12,522.4 Million by 2019 - New Report by MicroMarket Monitor 4Health News:North America Communication Test and Measurement (CT&M) Market Worth $1.9 Billion by 2018 - New Report by MicroMarket Monitor 2Health News:North America Communication Test and Measurement (CT&M) Market Worth $1.9 Billion by 2018 - New Report by MicroMarket Monitor 3Health News:North America Communication Test and Measurement (CT&M) Market Worth $1.9 Billion by 2018 - New Report by MicroMarket Monitor 4Health News:North America Communication Test and Measurement (CT&M) Market Worth $1.9 Billion by 2018 - New Report by MicroMarket Monitor 5
... son or daughter starts having mood swings, and stays out late, ... is in love . ,The finding is based on ... Basel, who conducted it on 107 adolescents with an average age ... had indicated that they were in love, and were experiencing intense ...
... the Organization of the Islamic conference (OIC) who met at ... affairs . , Calling the public health services of ... Abdullah Ahmad Badawi said seven of the 10 nations with ... Muslim states. , While speaking at an inaugural ...
... slick has contaminated Melbourne's Yarra River, posing serious threat to ... warned against contact with the water until the slick - ... up. ,The Environment Protection Agency (EPA) is ... happened last Saturday but was not discovered until Tuesday by ...
... Minister Tony Blair in the next fortnight to discuss ... to work with the Prime Minister on a new ... Blair. ,Schwarzenegger would discuss a programme of ... on June 27, adds the source. ,The ...
... investigating officers obtained the university mental health records of Seung-Hui ... shooting rampages in American history. ,Cho killed himself ... he killed two students at a dormitory and then 30 ... at Virginia Tech. ,According to the panel members investigating ...
... of a small town in Australia, cut off by floods, ... a large consignment of beer by boat . ... region has been submerged since Sunday in floodwaters that have ... rains. ,The township's 400 residents were anxious that ...
Cached Medicine News:Health News:Muslim Nations Urged To Address Health Needs 2Health News:Australia Battles Oil Slick on Yarra River 2Health News:Virginia Tech Shooters Mental Health Records No More Secret 2
Product includes all 15 Lexi-Comps databases. Includes Lexi-drugs, the official reference of the American Pharmacists Association and the National Professional Society of Pharmacists....
... Knife with BD Xstar Blade includes a ... the blade in prodedure and handling. ... a grind-less process for manufacturing surgical blades. ... and consistency. The arch style, single-bevel ...
Electric high speed system....
The Durafuge 100 spins swing-out rotors at 4000 rpm and fixed-angle rotors at up to 6300 rpm....
Medicine Products: