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:


(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a ... can give their videos a whole new perspective by using the title layers ... Film Studios. , ProSlice Levels contains over 30 Different presets to choose from. ...
(Date:6/26/2016)... , ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal ... personalized through a fitness app. The fitness app plans to fix the two major problems ... offer a one size fits all type program , They don’t eliminate all ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American Institutes ... Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , ... advance care planning, healthcare costs and patient and family engagement. , AIR researchers ...
(Date:6/25/2016)... ... ... temporary closing of Bruton Memorial Library on June 21 due to a possible lice infestation, ... aspect of head lice: the parasite’s ability to live away from a human host, and ... necessary one in the event that lice have simply gotten out of control. , As ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... ... the United States, named Dr. Sesan Ogunleye, as the Medical Director of its new ... the facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... -- Research and Markets has announced the addition ... report to their offering. ... The World Market for Companion Diagnostics covers the world ... in the report includes the following: , ... by Region (N. America, EU, ROW), 2015-2020 , World ...
(Date:6/24/2016)...  Arkis BioSciences, a leading innovator in the ... cerebrospinal fluid treatments, today announced it has secured ... led by Innova Memphis, followed by Angel Capital ... Arkis, new financing will accelerate the commercialization of ... of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... 23, 2016 Research and Markets ... Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic ... Coating, Parenteral) - Global Forecast to 2021" report ... The global pharmaceutical excipients market is projected to ... of 6.1% in the forecast period 2016 to 2021. ...
Breaking Medicine Technology:
Cached News: