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:1/22/2015)... 23, 2015 Angelweddingdress is a famous wedding ... its customers to follow it on Facebook, Twitter, and Pinterest. ... Day gift. Angelweddingdress draws a lottery every week. , Moreover, ... Feb. 28, 2015. Click Angelweddingdress homepage for more ...
(Date:1/22/2015)... 22, 2015 A new white paper ... and person-centeredness in the long-term care environment as well ... the continuum. The paper, “The Power of Person-Centeredness in ... and practices of the patient, resident and family experience ...
(Date:1/22/2015)... Joan Lunden, award-winning American journalist, beloved television host, ... 32nd Annual Miami Breast Cancer Conference planned and ... , shares that “a fast-growing, virulent” cancer in her ... not followed up her clean mammogram with an ultrasound. ...
(Date:1/22/2015)... years since the release of their debut recording Love is King, ... & Matthew Love – the duo are pleased to announce their ... Swan Records on February 24, 2015. , THE ROAD offers the ... all of us to walk out of the mire of our ...
(Date:1/22/2015)... Compare-autoinsurance.org has released a new blog post presenting a ... insurance policy . , Some types of vehicles cannot be ... newly released blog post to see if their vehicle qualifies for ... are some of the cars that cannot be covered by a ...
Breaking Medicine News(10 mins):Health News:Angelweddingdress Invites Its Customers To Follow It On Facebook, Twitter, And Pinterest 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 2Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 3Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 4Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 5Health News:Joan Lunden Reveals Diagnostic Approach That Led To Early Detection;To Keynote 32nd Annual Miami Breast Cancer Conference® 6Health News:THE ROAD by Avasa & Matthew Love -- A New Album 2Health News:THE ROAD by Avasa & Matthew Love -- A New Album 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 4Health News:Some Vehicles Cannot Be Covered By An Auto Insurance Policy! 2
(Date:1/22/2015)... Jan. 22, 2015  ViewRay™, a privately held medical device ... exclusive distributor agreement with ITOCHU Corporation (Tokyo Stock Exchange ... for the treatment of cancer in Japan ... the world,s first and only MRI-guided radiation therapy system ...
(Date:1/22/2015)... Calif. , Jan. 22, 2015  Amgen (NASDAQ: AMGN ... full year 2014 financial results on Tuesday, Jan. 27, 2015, after ... followed by a conference call with the investment community at 2 ... Robert A. Bradway , chairman and chief executive officer, and other ...
(Date:1/22/2015)... DUBLIN , Jan. 22, 2015 Research and ... the addition of the "Microbiology Testing/Clinical Microbiology ... - Global Forecast to 2019" report to ... a wide array of techniques for the detection ...
Breaking Medicine Technology:ITOCHU Named the Exclusive Distributor for ViewRay's MRI-Guided Radiation Therapy System in Japan 2Amgen Announces Webcast of 2014 Fourth Quarter and Full Year Financial Results 2Global Microbiology Testing/Clinical Microbiology (Instrument, Analyzer, Incubator, Kit, Microscope, Molecular Diagnostics) Market - Forecast to 2019 2Global Microbiology Testing/Clinical Microbiology (Instrument, Analyzer, Incubator, Kit, Microscope, Molecular Diagnostics) Market - Forecast to 2019 3
Cached News: