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:10/20/2014)... 2014 Allegheny General Hospital’s (AGH) Cardiovascular ... physicians to repair a damaged mitral valve as the ... system, developed by Abbott Vascular , is designed ... life-threatening condition in which the heart’s mitral valve leaflets ... from the heart’s left ventricle into the left atrium. ...
(Date:10/20/2014)... IN (PRWEB) October 20, 2014 ... Start, a secure cloud solution that enables healthcare ... of the ultimate healthcare-specific customer relationship management (“CRM”) ... meet the unique needs of the healthcare industry, ... experience for providers and patients by combining healthcare ...
(Date:10/20/2014)... 2014 AttorneyOne.com, a recognized authority on law, ... the FDA on Sit and Slim II . ... purchase or use Sit and Slim II because it contains ... promoted as weight loss product on various websites and possibly ... in 2010 for safety reasons, can significantly increase blood pressure ...
(Date:10/20/2014)... National Teen Driver Safety Week is October 19-25, 2014 and ... AAP, http://www.ohioaap.org ) is joining the National Highway Traffic ... talk to their teens and always set the rules before ... leading cause of death for U.S. teens. In 2012, there ... (42%) of those teen drivers were killed in crashes. While ...
(Date:10/20/2014)... 20, 2014 Houston plastic surgeon ... key elements of his innovative True Form Tummy ... surgery residents and faculty at The University of ... too, was once a medical student. Patronella, who is ... cosmetic plastic surgery practices in Texas, The Aesthetic ...
Breaking Medicine News(10 mins):Health News:Allegheny General Hospital Introduces New, Beating-Heart Procedure for Mitral Valve Repair 2Health News:Allegheny General Hospital Introduces New, Beating-Heart Procedure for Mitral Valve Repair 3Health News:Healthcare Relationship Management (HRM) Leader hc1.com® Launches hc1® Quick Start™ 2Health News:FDA Advises Not to Use Sit and Slim II: AttorneyOne Monitors and Keeps Consumers Informed 2Health News:Ohio AAP Promotes National Teen Driver Safety Week 2Health News:Plastic Surgeon Patronella Presents Artistically-Inspired Tummy Tuck Method to Future Generation of Plastic Surgeons in Texas 2
(Date:10/17/2014)... , October 17, 2014 Investor-Edge ... Inc. (NASDAQ: ARNA ), NPS Pharmaceuticals Inc. ... XOMA ), Momenta Pharmaceuticals Inc. (NASDAQ: ... Free research on these five companies can be accessed ... on Thursday, October 16, 2014, ended on a mixed ...
(Date:10/17/2014)... 17, 2014  UBM Medica US announces that ... and other clinicians who treat patients with type ... effective use of insulin .  Nearly ... replacement therapy – daily injections of one or ... in the function of pancreatic beta cells. Insulin is ...
(Date:10/17/2014)... -- China Biologic Products, Inc. (NASDAQ: CBPO, "China Biologic" ... biopharmaceutical company in China , ... from the China Food and Drug Administration (the ... concentrate ("PCC") at its Shandong Taibang facility. The ... facility for Good Manufacturing Practices ("GMP") compliance in ...
Breaking Medicine Technology:Biotech Equities Technical Briefing - Arena Pharma, NPS Pharma, XOMA, Momenta Pharma, and Catalyst Pharma Partners 2Biotech Equities Technical Briefing - Arena Pharma, NPS Pharma, XOMA, Momenta Pharma, and Catalyst Pharma Partners 3Biotech Equities Technical Briefing - Arena Pharma, NPS Pharma, XOMA, Momenta Pharma, and Catalyst Pharma Partners 4Biotech Equities Technical Briefing - Arena Pharma, NPS Pharma, XOMA, Momenta Pharma, and Catalyst Pharma Partners 5Endocrinology Network Features Special Coverage on Effective Use of Insulin 2Endocrinology Network Features Special Coverage on Effective Use of Insulin 3China Biologic Receives Approval for Commercial Manufacturing of Human Prothrombin Complex Concentrate at Shandong Taibang Facility 2China Biologic Receives Approval for Commercial Manufacturing of Human Prothrombin Complex Concentrate at Shandong Taibang Facility 3
Cached News: