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FDA grants fast-track designation for metastatic melanoma treatment.
2004 NOV 3 - (NewsRx.com & NewsRx.net) -- Medarex (MEDX) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Medarex's fully human antibody against human CTLA-4, MDX-010 in combination with MDX-1379, a melanoma vaccine, for the treatment of previously treated, unresectable Stage III and Stage IV metastatic melanoma.
Medarex is currently conducting a Phase III clinical trial with MDX-010 and MDX-1379 combination therapy in Stage III and IV melanoma at multiple sites within the United States. In this trial, approximately 750 patients with previously treated Stage III or Stage IV metastatic melanoma are expected to be enrolled. The patients will be randomized to receive one of three regimens:
- MDX-010 in combination with MDX-1379
- MDX-010 alone or
- MDX-1379 alone.
The randomization will be done on a 3:1:1 basis, with 60% of the patients receiving the combination therapy. All patients receiving MDX-010 will receive a dose of three mg/kg every three weeks for up to four doses. Best objective ...
- Medarex Receives FDA Fast Track Designation for MDX-010 Treatment of Metastatic...
- Press release article from: PR Newswire October 5, 2004 700+ words
...010 in combination with MDX-1379, a melanoma vaccine...previously treated, unresectable Stage III and Stage IV metastatic melanoma...Phase III clinical trial with MDX-010 and MDX-1379 combination therapy in Stage III and IV melanoma at multiple...
- Patient enrollment commences for MDX-010 phase III trial in metastatic melanoma.
- Newspaper article from: Science Letter October 26, 2004 700+ words
...United States for its MDX-010 phase III clinical...with previously treated stage III or stage IV metastatic...one of three regimens: MDX-010 in combination with...Additionally, in June 2004, MDX-010 received orphan...high-risk stage II, stage III, and stage IV melanoma...
- Medarex Commences Enrollment in Phase III Clinical Trial for MDX-010 in...
- Press release article from: PR Newswire September 28, 2004 700+ words
...United States for its MDX-010 Phase III clinical...with previously treated Stage III or Stage IV metastatic...one of three regimens: MDX-010 in combination with...Additionally, in June 2004, MDX-010 received orphan...high-risk Stage II, Stage III and Stage IV melanoma...
- Medarex Begins Second Pivotal Study Of MDX-010 In Melanoma.
- Magazine article from: BIOWORLD Today Boggs, Jennifer April 3, 2006 700+ words
...the ongoing combination trial of MDX-010 and our MDX-1379 peptide vaccine." In September...patients with previously treated Stage III or Stage IV metastatic melanoma...treatment regimens: 3 mg/kg of MDX-010 plus MDX-1379 or one of...
- Alliance formed to develop melanoma product MDX-010.
- Newspaper article from: Pharma Business Week December 13, 2004 700+ words
...suppressing the immune response. MDX-010 also has the potential...fight tumors. In June 2004, MDX-010 received orphan drug designation...treatment of high risk Stage II, Stage III and Stage IV melanoma. The FDA has granted Fast Track status to MDX-010 in combination with MDX...
- Medarex Announces Special Protocol Assessment Agreement with FDA to Initiate...
- Press release article from: PR Newswire August 23, 2004 700+ words
...with previously treated Stage III or Stage IV metastatic...one of three regimens: MDX-010 in combination...tumors. In June 2004, MDX-010 received orphan...high-risk Stage II, Stage III and Stage IV melanoma. MDX-010 is also currently...
- MEDAREX, BMS MDX-010 DEAL: PAYMENTS COULD TOTAL $530M.
- Magazine article from: BIOWORLD Today Lorenzo, Aaron November 9, 2004 700+ words
...granted fast-track status to MDX-010 in combination with MDX-1379 for treatment of patients...patients with previously treated Stage III or Stage IV metastatic melanoma...randomized to one of three regimens: MDX-010 in combination with MDX...
- Bristol-Myers Squibb Company and Medarex Form Global Development and...
- Press release article from: PR Newswire November 8, 2004 700+ words
...suppressing the immune response. MDX-010 also has the potential...fight tumors. In June 2004, MDX-010 received orphan drug designation...treatment of high risk Stage II, Stage III and Stage IV melanoma. The FDA has granted Fast Track status to MDX-010 in combination with MDX...