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


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:

(Date:11/27/2015)... ... November 27, 2015 , ... The rapid speed at which ... age, more care is needed, especially with Alzheimer’s, dementia and other cognitive conditions ... overworked. The forgotten part of this equation: 80 percent of medical care occurs ...
(Date:11/27/2015)... County, CA (PRWEB) , ... November 27, 2015 , ... ... season , The company is offering customers 10% off of their purchase of lice ... any treatment at full price. According to a company spokesperson. “Finding lice is a ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... ... motto of progress through sharing, the 2016 Building Better Radiology Marketing Programs ... conference will begin on Sunday, March 6, 2016, at Caesars Palace in Las ...
(Date:11/27/2015)... ... November 27, 2015 , ... Keeping ... platform for mental health and wellness consultation, has collaborated with a leading web-based ... the knowledge gap experienced by parents and bring advice from parenting experts within ...
(Date:11/27/2015)... , ... November 27, 2015 , ... Avid collector, Andrew ... Arbor Michigan boxing style concert posters. This is one of Joplin's most famous and ... House at the University of Michigan in Ann Arbor. The According to Hawley, "It ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 26, 2015 Research and Markets ( ... "2016 Future Horizons and Growth Strategies in ... Shares, Country Segment Forecasts, Competitive Intelligence, Emerging Opportunities" ... --> --> This new ... Japanese therapeutic drug monitoring market, including emerging tests, ...
(Date:11/26/2015)... 26, 2015 Research and Markets ( http://www.researchandmarkets.com/research/92lrwg/advanced_wound ... Wound Care Market by Type (Dressings, Therapy Devices, Active ... Facility, Out-Patient Facility), and Geography - Global Forecast to ... --> --> The purpose of ... forecast of the global advanced wound care market. It ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 /PRNewswire/ ... the addition of the "Radioimmunoassay Market ... User (Hospital, Pharmaceutical Industry, Academics, Clinical Diagnostic ... - Global Forecast to 2020" report ... ) has announced the addition of the ...
Breaking Medicine Technology:
Cached News: