HOME >> MEDICINE >> NEWS
US FDA grants full approval to DOXIL(R) following submission of phase III data

Bridgewater, N.J. February 7, 2005 -- The U.S. Food and Drug Administration (FDA) has granted full approval to DOXIL (doxorubicin HCl liposome injection) for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. DOXIL, marketed in the United States by Tibotec Therapeutics, Division of Ortho Biotech Products, L.P., originally received accelerated approval for refractory ovarian cancer in June 1999. As a result of the full approval, the product label for DOXIL has been updated to include survival, time to disease progression and tumor response rate data from a randomized Phase III clinical study.

Under accelerated approval, DOXIL was indicated for the treatment of metastatic ovarian cancer in patients with disease that was refractory to both paclitaxel- and platinum-based chemotherapy regimens. This approval was based on tumor response rates from three Phase II studies. According to the terms of the accelerated approval, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) completed a randomized Phase III clinical study to formally demonstrate the drug's clinical benefit in patients with relapsed ovarian cancer. In March 2004, J&JPRD submitted a supplemental new drug application (sNDA) based on data from the Phase III study.

"The Phase III data provide evidence of the product's clinical benefit for patients with relapsed ovarian cancer," commented Alan N. Gordon, M.D., of the University of Arizona School of Medicine and Arizona Gynecologic Oncology, in Phoenix, Ariz., and lead author of the Phase III study, known as DOXIL Study 30-49.

In the randomized, multi-center, open-label, Phase III study, 474 patients with recurrent epithelial ovarian cancer were randomly assigned to receive either DOXIL 50 mg/m2 every 28 days or topotecan HCl 1.5 mg/m2/day for five consecutive days every 21 days. A total of 239 patients received DOXIL; 235 patients received
'"/>


7-Feb-2005


Page: 1 2 3

Related medicine news :

1. UNH launches 2nd spinout company with NIH grants
2. Disease testing for immigrants: Discrimination disguised as public health policy
3. Four teams awarded inaugural translational cancer research grants
4. Immigrants, beware: Living in the United States is fattening
5. Prevalence of obesity among immigrants increases with longer residency in US
6. FDA grants accelerated approval of TYSABRI, formerly antegren, for the treatment of MS
7. Dana-Farber receives CDC grants to develop health promotion/prevention programs in the work place
8. Speech recognition experts at OGI School of Science & Engineering receive nearly $700,000 in grants
9. Should compulsory screening of immigrants be part of UK public health policy?
10. NIH grants support health disparities biomedical research
11. NCCAM awards planning grants for International Centers for Research

Post Your Comments:
*Name:
*Comment:
*Email:
TAG: FDA grants full approval DOXIL following submission phase III data

(Date:4/14/2014)... orphaned by HIV/AIDS in South Africa may provide insight ... behavior issues in other areas of the world, which ... that could lead to successful interventions. , A ... United Nations mentions that due to the HIV/AIDS pandemic, ... African, children are at an increased risk for mental ...
(Date:4/14/2014)... A new study shows that moderate to severe ... risk of stroke, cancer and death. , Results of ... to severe obstructive sleep apnea were four times more ... times more likely to have a stroke (HR = ... (HR = 3.4), and 2.5 times more likely to ...
(Date:4/14/2014)... Dallas study involving serious youth offenders, the answer to one ... seven years: "How long do you think you,ll live?", According ... offending over time., Author Dr. Alex Piquero said the study ... of them offend at very high rates and commit more ... much later in life offend much less., "In a lot ...
(Date:4/14/2014)... with symptoms increasing dramatically during some of the most important ... has found. , Depressive symptoms increased on average by 68 ... young men, who were around 25 years old when they ... their children. The results of the study were published April ... is the first to identify when young fathers are at ...
(Date:4/14/2014)... Lower weight babies and babies who aren,t breastfed ... risk of developing chronic inflammation and related health ... study. , "There were good reasons to hypothesize ... inflammation in adulthood," says Thomas McDade (Northwestern University), ... in the Child & Brain Development program. "It ...
Breaking Medicine News(10 mins):Health News:Researchers identify children with emotional behavior difficulties 2Health News:Researchers identify children with emotional behavior difficulties 3Health News:Study links severe sleep apnea to increased risk of stroke, cancer and death 2Health News:UT Dallas study: Youth who fail to envision future commit more crimes 2Health News:Young dads at high risk of depression, too 2Health News:Low birth weight, less breastfeeding create later health risks 2
(Date:1/15/2014)... -- AARP Foundation today announced it has established a ... from the severe cold weather that has gripped much ... to helping those in need; so to support these ... dollar-for-dollar contributions up to $250,000, which could mean up ... administered through AARP Foundation. (Logo: ...
(Date:1/15/2014)... Jan. 15, 2014  Celsion Corporation (the "Company") (NASDAQ: ... has received commitments from institutional investors to purchase ... Company,s common stock in an at-the-market registered direct ... The Company entered into definitive purchase ... Company agreed to sell an aggregate of 3,603,603 ...
(Date:1/15/2014)... January 15, 2014 Shire plc (LSE: ... waived the Office of Fair Trading (OFT) approval condition to ... of ViroPharma Incorporated (NASDAQ: VPHM).   As a ... on OFT approval, and Shire expects to complete the tender ... time, subject to the satisfaction of all of the remaining ...
Breaking Medicine Technology:AARP Foundation Establishes Winter Relief Fund for Older Adults Suffering from the Severe Cold Weather 2AARP Foundation Establishes Winter Relief Fund for Older Adults Suffering from the Severe Cold Weather 3Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 2Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 3Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 3
Cached News: