Navigation Links
New Drug Application for Ibrutinib Submitted to the U.S. FDA
Date:7/10/2013

SUNNYVALE, Calif., July 10, 2013 /PRNewswire/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The submission was based on data from Phase II studies in patients with relapsed/refractory MCL and in patients with relapsed/refractory CLL/SLL. With this submission, Pharmacyclics is also requesting Priority Review. Pharmacyclics is jointly developing ibrutinib with Janssen.

The NDA submission follows the receipt of a Breakthrough Therapy Designation from the FDA in February 2013 for ibrutinib as a monotherapy for the treatment of patients with relapsed/refractory MCL, and receipt of a second Breakthrough Therapy Designation for the treatment of patients with CLL/SLL with deletion of the short arm of chromosome 17 (del 17p). Further information on the implications of this filing for potential commercialization will be provided subsequent to the FDA rendering a decision on the filing.

"We are very excited having achieved this major milestone. This first NDA for ibrutinib was made possible in record time because of the continuous support and consultations we received from the FDA," said Dr. Urte Gayko, Senior Vice President of Global Regulatory Affairs, Pharmacyclics. "We look forward to continuing to work with the FDA as they review the application for ibrutinib through the new Breakthrough Therapy Designation process."

"These past months have been enormously active and productive for Pharmacyclics and our ibrutinib partner, Janssen. We received our first of three Breakthroug
'/>"/>

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

Page: 1 2 3 4 5 6

Related medicine technology :

1. Zogenix Submits New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Zohydro™ for Treatment of Chronic Pain
2. Ventana Receives FDA Clearance for p53 (DO-7) Image Analysis and Digital Read Applications
3. Bio-AMD, Inc.; Patent Application for Cartridge Test Cap
4. Global Ablation Technologies Market (2011-2016) - By Application and Devices in Radiofrequency, Cryoablation, Microwave, Ultrasound, Hydrothermal, Radiation, Electrical, Light/Laser and Hydromechanical - Global Trends & Competitive Analysis
5. Rubicon Genomics Launches ThruPLEX™ Family of Sample Preparation Products for Next Generation Sequencing Applications
6. Ambit Biosciences and Teva Announce Clearance of an Investigational New Drug (IND) Application for CEP-32496, A Novel BRAF(V600E) Inhibitor
7. CSL Behring Announces FDA Filing of Biologics License Application for 4-Factor PCC for Urgent Reversal of Vitamin K Antagonist Anticoagulant Therapy
8. Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin to Treat Patients with Type 2 Diabetes
9. Philips demonstrates innovations in nuclear medicine imaging with a comprehensive portfolio of NM applications for IntelliSpace Portal
10. Clinical Safety Data for ChromaDex®s Patented pTeroPure® (pterostilbene) Released at 6th World Congress on Polyphenols Applications in Paris
11. UltraTape announces Cleanroom Labels for Cryogenic Laboratory applications
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... , Dec. 23, 2014  Medical Science Liaisons play ... key link between the medical device industry and key ... in the coming years as the device industry relies ... According to research by benchmarking firm, Best Practices, LLC, ... an important edge is by harnessing new technology to ...
(Date:12/22/2014)... Tenn. , Dec. 22, 2014   TRU-D ... automated, no-touch UV disinfection robot, announced today that the ... Schedule contract through November 2019.   This ... rapidly engage all levels of government purchasers, including Department ... as well as Homeland Security contacts purchasing solutions for ...
(Date:12/22/2014)... /PRNewswire/ -- RXi Pharmaceuticals Corporation (NASDAQ: RXII ... and commercializing innovative therapies addressing major unmet medical ... open letter to shareholders from President & CEO, ... Dear RXi Shareholders, In the ... posted on certain social media sites seem to ...
Breaking Medicine Technology:Role of Medical Science Liaisons Evolving in Medical Device Sector 2TRU-D SmartUVC LLC Awarded General Services Administration Contract to Expand Government Customer Base 2RXi Pharmaceuticals Issues Open Letter to Shareholders 2RXi Pharmaceuticals Issues Open Letter to Shareholders 3RXi Pharmaceuticals Issues Open Letter to Shareholders 4RXi Pharmaceuticals Issues Open Letter to Shareholders 5RXi Pharmaceuticals Issues Open Letter to Shareholders 6
... 2011 StreamVenue Healthcare has partnered its ... Institute for Surgery At Presbyterian Hospital Dallas to ... StreamVenue Healthcare rolled out this year its ... endoscopy technology. The package includes EndoCom hardware; StreamingOR, ...
... Md., April 22, 2011 Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: ... development and commercialization of products for central nervous system disorders, ... of 2011, on Thursday, May 5, 2011, before the market ... disseminated at that time. Mihael H. Polymeropoulos, M.D., ...
Cached Medicine Technology:StreamVenue Healthcare Pacing Future of Endoscopy Technology 2Vanda Pharmaceuticals to Announce First Quarter 2011 Financial Results on May 5, 2011 2
(Date:12/26/2014)... Parker & Sons, Inc. a ... heating, cooling and plumbing contractor services throughout Arizona ... in 2014 with regard to air-conditioning systems. Residential ... known for its incredibly hot summers. Working with ... and details of a wide variety of systems ...
(Date:12/25/2014)... 2014 This is a professional and ... Sterilizers industry with a focus on the Chinese market. ... of the Sterilizers manufacturers and is a valuable source ... in the industry. This report provides a basic overview ... technology. In this part, the report presents the company ...
(Date:12/25/2014)... TX (PRWEB) December 26, 2014 ... Market Analysis to 2023” focuses on the current ... opportunities in the colorectal cancer market. Stivarga is ... of colon or rectal cancer. Boehringer Ingelheim is ... for the treatment of refractory CRC in the ...
(Date:12/25/2014)... New York, New York (PRWEB) December 25, 2014 ... of the 2010 DePuy ASR hip recall ( http://www.consumerinjurylawyers.com/DePuy/ ... Liebhard LLP reports. According to an Order issued in ... November 20th, the Court will convene an open conference ... Federal Building and United States Courthouse in West Palm ...
(Date:12/25/2014)... iFitDress.com, the popular online supplier of wedding dresses and special ... black one-shoulder cocktail dresses . In addition, all these ... discounted prices, up to 70% off. , The ... only. You know, we have thousands of frequent callers in ... items can visit our website for more details. The current ...
Breaking Medicine News(10 mins):Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 2Health News:Parker & Sons Announces Record Demand For 24 Hour Emergency Services In 2014 With Regard To Air-Conditioning Systems 3Health News:Sterilizers Industry Global and Chinese Analysis for 2009-2019 Now Available at ReportsnReports.com 2Health News:Sterilizers Industry Global and Chinese Analysis for 2009-2019 Now Available at ReportsnReports.com 3Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 2Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 3Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 4Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing DePuy ASR Hip Lawsuit Set to Convene Conference in January, Bernstein Liebhard LLP Reports 3Health News:iFitDress.com: Black One-Shoulder Cocktail Dresses for 2015 2
... State University of New Jersey have come up with ... determining the quality of mate in humans.// , ... mates among many animal species. Impressive dancers attract more ... association with computer scientist at the University of Washington ...
... Four women who lost their children in the tsunami last ... that enabled them to conceive again.// , ,Despite having ... Tamil Nadu in southern India will now be able to ... surgery called recanalization. , ,"We cannot get back our ...
... how old they get, never lose their beauty - they merely ... ,Jacqueline Saburido was a very normal girl who was in ... incident that occurred on the 19th of September 1999 changed her ... than 60% of her body was burnt. She lost her ears, ...
... Marie Rogers has won the right to fight for receiving the ... an aggressive type of breast cancer and wants to make sure ... the disease is in its early stage has meant that the ... have already taken legal recourse for the same. Even Patricia Hewitt, ...
... by Dr Michael Fenech studied the damage of excess alcohol on ... excess intake of // alcoholic beverages resulted in increased risk of ... the study, six men aged 21-26 stuck to a diet low ... of either complete red wine, red wine with the alcohol removed ...
... to have been responsible for much of the DNA among ... The tendency of human beings to live in settlements and ... selection process. ,One way to look for ... to study mutations called single-nucleotide polymorphisms (SNPs) - single-letter differences ...
Cached Medicine News:Health News:Recanalization enables Tsunami mourners to parent again 2Health News:The Looming Controversy Surrounding Facial Transplant 2Health News:DNA Underwent Changes Due To Culture 2
... 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 ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... 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 ...
Medicine Products: