Navigation Links
The Leukemia & Lymphoma Society Applauds FDA's Approval of Ibrutinib for Certain Patients with Mantle Cell Lymphoma
Date:11/13/2013

WHITE PLAINS, N.Y., Nov. 13, 2013 /PRNewswire/ -- Today's U.S. Food and Drug Administration (FDA) approval of ibrutinib to treat patients with mantle cell lymphoma (MCL) is a significant advance for patients with this blood cancer.  It was approved as a single agent for treatment of patients with MCL who have received at least one prior therapy.

Ibrutinib is the second drug with "breakthrough therapy designation" to receive FDA approval. Ibrutinib is a therapy that  targets an enzyme, Bruton's tyrosine kinase (BTK), which promotes growth of  B-cell cancers, including MCL, chronic lymphocytic leukemia (CLL), Waldenstrom's macroglobulinemia (WM), follicular lymphoma, diffuse large B-cell lymphoma, hairy cell leukemia (HCL) and multiple myeloma.

"After the FDA earlier this year designated ibrutinib as a breakthrough therapy for patients with certain forms of blood cancers, we were all hopeful that it was only a matter of time before the therapy was approved to treat these patients, who have few good treatment options," said John Walter, president and CEO of The Leukemia & Lymphoma Society (LLS).

LLS is eager to learn the outcome of FDA's ongoing review of ibrutinib for patients with chronic lymphocytic leukemia (CLL) and Waldenstrom's macroglobulinemia (WM).

"Many patients with MCL and other B-cell cancers do not respond well to standard therapies and new treatments such as ibrutinib are urgently needed," said Louis J. DeGennaro, Ph.D., LLS chief mission officer.  "LLS exists to find cures and ensure access to treatments for blood cancer patients, and any new advance that brings the potential to help save more lives is good news."

LLS funding has supported clinical trials and laboratory studies of ibrutinib for patients with CLL, and more recently for patients with HCL. John C. Byrd, M.D., of the Ohio State University, is a world-renowned CLL expert who leads an LLS-funded research team that has been instrumental in advancing ibrutinib. Other LLS-funded researchers, including Jonathan Friedberg, M.D., of University of Rochester and Jennifer Brown, M.D., Ph.D., of Dana-Farber Cancer Institute, have also played important roles in clinical trials for ibrutinib.

LLS also helped advance another BTK inhibitor, CC-292 (formerly AVL-292), which showed encouraging activity in an early trial for CLL and lymphoma patients, and is now being tested in combination therapies. LLS partnered with Avila Therapeutics through LLS's Therapy Acceleration Program, from March 2010 until Celgene Corporation acquired Avila in January 2012, bringing critical capital and commercialization expertise to the development of this promising agent.

About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society® (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, multiple myeloma, and improve the quality of life of patients and their families. LLS funds livesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access o quality, affordable, coordinated care.

Founded in 1949 and headquartered in White Plains, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org. Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 6 p.m. ET.

Contact: Andrea Greif
914-821-8958
andrea.greif@lls.org


'/>"/>
SOURCE The Leukemia & Lymphoma Society
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Polaris Group Announces Treatment of First Patient in Phase 2 Study of ADI-PEG 20 in Acute Myeloid Leukemia
2. Top Trial Firm Cohen, Placitella & Roth, PC Investigating Ariad Pharmaceuticals, Inc., for Suspending Sales of its Leukemia Drug Iclusig
3. The Leukemia & Lymphoma Society Issues Statement Regarding the Status of Iclusig (Ponatinib)
4. The Leukemia & Lymphoma Society and the Knight Cancer Institute Launch Groundbreaking Collaboration to Improve Outcomes for Acute Myeloid Leukemia Patients
5. OpportunityAnalyzer: Acute Myeloid Leukemia (AML) - Opportunity Analysis and Forecasts to 2017
6. St. Jude Childrens Research Hospital study yields new strategy against high-risk leukemia
7. The Leukemia & Lymphoma Society Co-Pay Assistance Fund Surpasses $200 Million
8. Ibrutinib Study Results in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia Published in The New England Journal of Medicine
9. Celebrating 25 Years and Counting: Leukemia and Lymphoma Societys "Team In Training" Goes the Distance and Beyond for Blood Cancer Patients
10. AbbVie Presents Preliminary Results from Phase I Study of Investigational Oncology Compound ABT-199/GDC-0199 in Patients with High-Risk Chronic Lymphocytic Leukemia (CLL) at European Hematology Association Annual Meeting
11. The Leukemia & Lymphoma Society and Dana-Farber Cancer Institute to Bring Clinical Trials to Local Communities
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... and SEOUL, South Korea , ... and Macrogen, Inc. today announced they will form ... procedures for precision medicine in cancer. The goal ... DEPArray™ digital-sorting technology with Macrogen,s high-throughput Next Generation ... under the Clinical Laboratory Improvement Amendments (CLIA) of ...
(Date:2/12/2016)... 12 februari 2016 AAIPharma Services ... leverancier van productie en ontwikkeling op maat ... vandaag een uitbreiding aan van steriele vul- ... in Charleston, SC . ... meerdere recente investeringen. http://photos.prnewswire.com/prnh/20150806/256637LOGO ...
(Date:2/11/2016)... 11, 2016 - Cardiac ... Personalized Medicine and Cancer Therapy. - European Point ... Testing Markets. - Key Diagnostic Testing Markets. ... Diagnostics in Genetic Testing. - Molecular Diagnostics in ... - Over-the-Counter Diagnostic Products World Markets. - Point ...
Breaking Medicine Technology:
(Date:2/12/2016)... ... February 12, 2016 , ... According to an article published February ... a significant portion of hernia repairs throughout the United States. Commenting on this article, ... notes that this trend has not only been expected, but it seems to be ...
(Date:2/12/2016)... , ... February 12, 2016 , ... CDRH Enforcement Trends: , Back to the Future ... , As Winston Churchill said, “Those who don’t learn from history are doomed ... to expect when they come knocking this year. But that takes time. , Take ...
(Date:2/12/2016)... ... February 12, 2016 , ... T.E.N., ... have closed for the ISE Southeast Awards 2016. Finalists and winners of the ... ISE® Southeast Executive Forum and Awards Gala on March 15, 2016 at the ...
(Date:2/12/2016)... ... February 12, 2016 , ... AssureVest Insurance Group, a ... initiating a charity drive that will raise funds earmarked to purchase computers and software ... Elementary School. , “My school is in a low-income area and has more than ...
(Date:2/12/2016)... ... 2016 , ... Donor Network West, the organ procurement organization that heals lives ... San Ramon Regional Medical Center. Under the collaboration, the first of its kind, specific ... a more certain time frame for donor families for the recovery of organs. ...
Breaking Medicine News(10 mins):