Navigation Links
FDA Accepts Genta's NDA Amendment as Complete Response for Genasense(R) Treatment of Chronic Lymphocytic Leukemia
Date:7/14/2008

Submission Based on Increased 5-Year Survival in Responding Patients

BERKELEY HEIGHTS, N.J., July 14 /PRNewswire-FirstCall/ -- Genta Incorporated (OTC Bulletin Board: GNTA) announced that the Food and Drug Administration (FDA) has accepted the Company's amendment to its New Drug Application (NDA) for Genasense(R) (oblimersen sodium) Injection as a "complete response". The NDA proposed the use of Genasense plus chemotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The recent submission was based on new information from the Company's completed, randomized Phase 3 trial that showed, among other findings, a significant increase in overall survival for patients who achieved a complete or partial response when treated with Genasense plus chemotherapy compared with patients treated with chemotherapy alone.

The amendment responds to a communication received in March 2008 from FDA's Center for Drug Evaluation and Research (CDER) that denied Genta's appeal of a prior "non-approvable" decision of the Genasense NDA in December 2006. That communication described a regulatory path forward that included but was not limited to determination of long-term survival in patients who entered the study. FDA has informed the Company that it considers Genta's complete response as a Class 2 resubmission with a Prescription Drug User Fee Act (PDUFA) goal date of December 3, 2008.

"We are pleased that the FDA will formally review this new information, and we look forward to working with FDA's Division of Oncology Drug Products during their consideration of this amendment," commented Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer.

About Chronic Lymphocytic Leukemia

CLL is the most common form of leukemia in adults. According to the American Cancer Society, approximately 8,000 patients will be diagnosed this year. More than 60,000 people in the U.S. currently have CLL. The
'/>"/>

SOURCE Genta Incorporated
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. Partnering With MyPyramid: NUTRIKIDS Accepts the Challenge to Help Families Step Up to Healthier Living
2. AMEX Accepts Lorus Plan to Meet AMEXs Continued Listing Standards
3. Mike Huckabee Accepts Values Voter Presidential Debate
4. ev3 Inc. Accepts Resignation of Dr. John Simpson
5. Lieutenant Governor Catherine Baker Knoll Accepts Women in Government Presidential Leadership Award
6. FDA Accepts New Drug Application for NEBIDO(R) Submitted by Indevus
7. Governor Rendell Accepts National Health Care Reform Pioneer Award
8. American Stock Exchange Accepts Encisions Plan to Regain Compliance
9. FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
10. FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
11. Nuvo Research and Paladin announce amendments to Pennsaid and Pennsaid Plus agreements
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/20/2014)... August 20, 2014 A new trend ... a medical exam before issuing an approximate quote for ... company is now helping the public to obtain life ... system at http://quotespros.com/life-insurance.html . , The coverage ... more regulations have appeared in many U.S. states. Some ...
(Date:8/20/2014)... -- A group representing U.S. obstetricians is calling for ... According to the American College of Obstetricians and Gynecologists ... the safety and effectiveness of flu vaccination during pregnancy. ... be particularly dangerous to pregnant women, as it can ... Riley, chair of the college,s Immunization Expert Work Group, ...
(Date:8/20/2014)... study in Australia examined patient and tumor characteristics ... of tumor cell growth) in an effort to ... patients. , Author: Sarah Shen, ... and colleagues. , Background: The tumor characteristic ... has been connected with prognosis and survival in ...
(Date:8/20/2014)... Aug. 20, 2014 -- An imaging study of ... found deficits in specific regions of brain white ... in CCS users. , Researchers used diffusuion ... with fractional anisotropy, to investigate the white matter ... in multiple regions of the brain, including the ...
(Date:8/20/2014)... 20, 2014 (HealthDay News) -- Pigs, hearts transplanted into ... twice as long as previously achieved, researchers report. ... to use animal organs to shorten transplant waiting lists. ... engineered piglets into baboons, abdomens. The genetic engineering and ... are what enabled the hearts to survive for more ...
Breaking Medicine News(10 mins):Health News:Life Insurance Quotes Without Medical Exams Now Displayed to Adults at Insurance Website 2Health News:All Pregnant Women Need Flu Shot: Ob/Gyn Group 2Health News:Patient, tumor characteristics for high-mitotic rate melanoma 2Health News:Pigs' Hearts Beat for a Year in Baboons' Abdomens 2
... US researchers have successfully cured advanced melanoma skin cancer ... them to attack the cancer cells. // ,A ... have confirmed in their research that are published in ... as the most deadly type of skin cancer can ...
... NHS Quality Improvement Scotland have expressed concern over the ... their pap smears done regularly.// They feel that health ... give out importance of smears in preventing cervical cancer. ... take part in this highly successful screening programme," a ...
... Council suggests that cancers like cervical cancers or womb ... hormone in semen.// The researchers said that high levels ... a report in the Journal of Endocrinology and Human ... should ask their sexual partners to use condoms. "Sexually ...
... Sciences Department conducted a study to examine how bacteria ... like Antarctica and hot springs.// The team led by ... made a difference in the ability of the bacteria ... heat. The study appears in the journal Nature. ,The ...
... a potential of growing by a whopping 25 percent ... year by 2012, Tourism Minister Ambika Soni said Wednesday.// ... at the response from foreign patients, we estimate that ... said Soni while releasing the "Incredible India: The Global ...
... place, and in itself, can make heaven of Hell, and ... Though delicate as the most exquisite silk ever woven it ... strongest forces in this universe. Yet when subject to strain ... unravels deep within and yet another perfect body crumbles before ...
Cached Medicine News:Health News:Gene Therapy Used In Treating Cancer 2Health News:Bacteria Can Survive In Extreme Heat 2Health News:Medical Tourism can Fetch Rs.100 bn Annually by 2012 2Health News:Medical Tourism can Fetch Rs.100 bn Annually by 2012 3Health News:Mind in a Bind – Alternative Intervention 2Health News:Mind in a Bind – Alternative Intervention 3
(Date:8/20/2014)... NEW YORK , Aug. 20, 2014 ... market research report is available in its ... Insurance in Canada, Key Trends and Opportunities ... Synopsis The report ... insights into the Canadian personal accident and ...
(Date:8/20/2014)... The National Necrotizing Fasciitis Foundation (NNFF) today announced ... successfully treated for a life threatening form of necrotizing fasciitis, ... , Medical Director of Inpatient Wound Care and founder of ... Rancho Mirage, California . Dr. ... Crew at Seton Hospital in Daly City, ...
(Date:8/20/2014)... , Aug. 20, 2014   Ventana Medical ...  Group, today announced that its VENTANA System for ... in the European Union for routine pathology, including ... consisting of VENTANA Virtuoso software coupled with either ... HT slide scanner, provides automated digital slide creation, ...
Breaking Medicine Technology:Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 2Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 3Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 4Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 5Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 6Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 7Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 8Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 9Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 10Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 11Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 12Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 13Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 14Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 15Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 16Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 17Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 18Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 19Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 20Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 21Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 22Personal Accident and Health Insurance in Canada, Key Trends and Opportunities to 2017 23Rancho Mirage, California Physician Saves Casino Worker from Deadly 'Flesh Eating Disease' 2Rancho Mirage, California Physician Saves Casino Worker from Deadly 'Flesh Eating Disease' 3Rancho Mirage, California Physician Saves Casino Worker from Deadly 'Flesh Eating Disease' 4Rancho Mirage, California Physician Saves Casino Worker from Deadly 'Flesh Eating Disease' 5Rancho Mirage, California Physician Saves Casino Worker from Deadly 'Flesh Eating Disease' 6Full digitization of the anatomic pathology lab is here with the VENTANA System for Primary Diagnosis 2Full digitization of the anatomic pathology lab is here with the VENTANA System for Primary Diagnosis 3
... Alere Health, LLC announced today that it has ... Health Information Products Certification for Health Information Line. ... a 24/7 nurseline staffed by highly experienced, registered ... decisions by providing immediate clinical support for everyday ...
... BOTHELL, Wash., April 6, 2011 BioLife Solutions, Inc. ... grade biopreservation media products for cells and tissues, today ... ended March 31, 2011. This represents 6% sequential growth ... growth from the first quarter of 2010.   ...
Cached Medicine Technology:Alere Earns NCQA Health Information Products Certification for Health Information Line 2BioLife Solutions Announces Record Quarterly Revenue 2BioLife Solutions Announces Record Quarterly Revenue 3BioLife Solutions Announces Record Quarterly Revenue 4
... 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 ...
... 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 ...
... 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 ...
... 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: