Navigation Links
FDA Grants Orphan Drug Status To Eisai's Lenvatinib
Date:2/14/2013

WOODCLIFF LAKE, N.J., Feb. 14, 2013 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its investigational drug lenvatinib (E7080) for follicular, medullary, anaplastic and metastatic or locally advanced papillary thyroid cancer.

(Logo: http://photos.prnewswire.com/prnh/20120413/MM87168LOGO )

The Orphan Drug Act (ODA) allows FDA to grant orphan status to a drug which has the potential for the treatment, diagnosis, or prevention of a rare disease/disorder that affects fewer than 200,000 people in the United States.

Lenvatinib, discovered and developed by Eisai, is an investigational small molecule tyrosine kinase inhibitor being studied globally as an oral agent in patients with radioiodine-refractory differentiated thyroid cancer (DTC).

About Thyroid Cancer
Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located at the base of the throat near the trachea. It is more common in women than in men and usually occurs between the ages of 25 and 65.

The most common types of thyroid cancer, papillary and follicular (including Hurthle cell), are classified as differentiated thyroid cancer (DTC) and account for approximately 95 percent of all cases.  While most of these are curable with surgery and radioactive iodine treatment, a small percentage of patients do not respond to therapy. There are limited treatment options for this difficult-to-treat, life-threatening and resistant form of thyroid cancer.

Eisai Oncology
Eisai Oncology is dedicated to discovering, developing and producing innovative oncology therapies that can help make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission,
'/>"/>

SOURCE Eisai Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Nektar Announces that FDA Grants Fast Track Designation to NKTR-181, a New Oral Opioid Analgesic Molecule, for the Treatment of Moderate to Severe Chronic Pain
2. Community Foundation Announces $2.6 Million In Grants From Centinela Medical Funds
3. U.S. FDA Grants Priority Review to the New Drug Application for Bayers Regorafenib to Treat Patients with Metastatic Colorectal Cancer
4. European Commission Grants Orphan Medicinal Product Designation for Emmaus Medicals Sickle Cell Treatment
5. FDA Grants Orphan Drug Designation To GeNO LLC For Use Of Inhaled Nitric Oxide In Treatment Of Persistant Pulmonary Hypertension Of The Newborn (PPHN)
6. Rep. Fattah Announces More Than $10.7 Million in Grants for Neuroscience, Scientific and Medical Research in Philadelphia
7. U.S. FDA Grants Priority Review to Bedaquiline (TMC207) for Multi-Drug Resistant Tuberculosis Treatment
8. Neuralstem Grants First Licenses For CNS Therapy Surgical Devices
9. EMA Grants Orphan Designation to Edison Pharmaceuticals for EPI-743 for Treatment of Leigh Syndrome
10. As Global Telemedicine Market Reaches $2.5 Billion, Industry Leaders Gather in San Diego to Discuss Grants, Funding, Vendor Selection, Credentialing, and More
11. Nektar Announces that FDA Grants Fast Track Designation to Etirinotecan Pegol (NKTR-102) for the Treatment of Metastatic Breast Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... MYERS, Fla. , Jan. 23, 2015  Today the ... of Novartis, Bexsero® for the prevention of serogroup ... 25. Bexsero and Pfizer,s vaccine Trumenba®, which received FDA ... helping prevent this devastating disease. "I ...
(Date:1/23/2015)... Partnership to Fight Chronic Disease (PFCD) released a public opinion poll ... new study analyzing the impact of increased cost sharing on patient ... to educate policy makers and the public on the costs of ... how the Iowa healthcare exchange could be ...
(Date:1/23/2015)... , Jan. 23, 2015 More than a third ... quarter of those with private insurance, filled a prescription for ... a report in this week,s Morbidity and Mortality Weekly Report ... care providers to treat moderate to severe pain.  They are ...
Breaking Medicine Technology:The National Meningitis Association (NMA) Applauds FDA Approval of Second Vaccine To Protect Against Serogroup B Meningococcal Disease 2New research shows Iowa health exchange would benefit from improvements 2New research shows Iowa health exchange would benefit from improvements 3Opioid painkillers widely prescribed among reproductive age women 2Opioid painkillers widely prescribed among reproductive age women 3
... Data from experimental work on the use,of ... this week at the,International Society for Heart and ... donors after cardiac death,(DCD), also known as non-heart-beating ... shortage of suitable donor organs for lung, and,possibly ...
... Institute,s NABTT ... Consortium -, ... expansion of the clinical program for the company,s lead,product candidate, BSI-201, ... first poly ADP-ribose polymerase,(PARP) inhibitor in BiPar,s DNA repair portfolio, crosses ...
Cached Medicine Technology:Research Presented at ISHLT Shows Promise of Addressing Critical Organ Shortage and Better Organ Preservation 2Research Presented at ISHLT Shows Promise of Addressing Critical Organ Shortage and Better Organ Preservation 3BiPar Sciences Expands Clinical Program for BSI-201, a Novel DNA Repair Inhibitor, in Brain Cancer 2
(Date:1/22/2015)... (PRWEB) January 22, 2015 For over 20 years, ... Oceanside and Vista area has treated just about every ... personal injury circumstances. And for those same twenty-plus years, the ... of all those injuries with the best possible doctor. ...
(Date:1/22/2015)... Calif. (PRWEB) January 22, 2015 ... Susan Bonilla (D-Concord) and Kristin Olsen (R-Modesto) were ... their leadership in advancing biotechnology, biomedical science, medical ... and Olsen each received the “2014 Life Sciences ...
(Date:1/22/2015)... January 22, 2015 Payday lending practices ... communities and cause financial distress to the states that ... at Howard University’s Center on Race and Wealth. , ... economic activity, payday loans at the same time substantially ...
(Date:1/22/2015)... Compare-autoinsurance.org has released a new blog post presenting a ... insurance policy . , Some types of vehicles cannot be ... newly released blog post to see if their vehicle qualifies for ... are some of the cars that cannot be covered by a ...
(Date:12/26/2014)... Dallas, TX (PRWEB) December 26, 2014 The ... covered in this report. In 2013, GlobalData’s forecast estimates that ... the largest CRC market due to the high incidence of ... compared with the 5EU, Japan, and China. Increased sales of ...
Breaking Medicine News(10 mins):Health News:Industry Leading Chiropractor in Oceanside Joins the Doctors on Liens Network 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:Howard University Spotlights the Economic Impact of Payday Lending in Southern States 2Health News:Some Vehicles Cannot Be Covered By An Auto Insurance Policy! 2Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 2Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 3Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 4
... have slowed to less than half the growth rate from ... in the health care system continue to fuel underlying health ... , , Prepared by PricewaterhouseCoopers ... Factors Fueling Rising Healthcare Costs 2008" examines the causes of ...
... The Michigan Quality Council,(MQC) announces that the Detroit Athletic ... The Michigan Quality Leadership Award is ... It is awarded after a,rigorous review by a team of ... report for final evaluation to an independent panel of,judges. , ...
... definitively that blood stem cells are made during mid-gestational embryonic ... of blood vessels. , While the anatomic location in ... documented, the cell type from which they spring was less ... issue of the journal Cell Stem Cell , puts ...
... Dec. 3 BeaconEquity.com announces the availability of Trade Alerts on stocks making ... all of the daily trading notes for free by visiting: http://www.BeaconEquity.com/m ... Inc. (NYSE: SPC ), Williams-Sonoma Inc. (NYSE: WSM ), ... WXS ), Morgans Hotel Group Co. (Nasdaq: MHGC ) and ...
... U.S. Environmental Protection Agency,s process of generating risk assessments ... harmful chemicals found in the environment in order to ... challenges, and as a decision-making tool it is often ... the information needs of officials, says a new report ...
... CEO of Americans United for Life released the following statement ... make funding embryo destructive stem cell research a priority. , ... of the economy, to squander taxpayer resources on research that ... that in fact runs counter to the latest stem cell ...
Cached Medicine News:Health News:New Report Shows Slower Premium Growth, But Increasing Pressure to Address Waste in Health Care System 2Health News:New Report Shows Slower Premium Growth, But Increasing Pressure to Address Waste in Health Care System 3Health News:MICHIGAN QUALITY COUNCIL (MQC) NAMES The Detroit Athletic Club 2008 STATE QUALITY AWARD RECIPIENT 2Health News:UCLA scientists prove endothelial cells give rise to blood stem cells 2Health News:UCLA scientists prove endothelial cells give rise to blood stem cells 3Health News:Beacon Equity Issues Technical Trade Alerts on Recent Analyst Upgrades: SPC, WSM, MRX, WXS, MHGC, DSPG 2Health News:EPA's risk assessment process bogged down by unprecedented challenges; 2Health News:EPA's risk assessment process bogged down by unprecedented challenges; 3Health News:EPA's risk assessment process bogged down by unprecedented challenges; 4
... your practice with the advantages of the IPL ... of leg veins and other deeper vascular lesions. ... As a stand alone device or as an ... DL treats a range of conditions including: ...
Disposable. Sterile Suction Tubing....
... say the most efficient,aspiration is ... movement of the,cannula tip. Rigorous ... ARC-H II Reciprocating Cannula,assures that ... is,restricted to a longitudinal axis ...
Inquire...
Medicine Products: