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The FDA announced on Friday, March 25, that it had approved ipilimumab (Yervoy) for the treatment of metastatic melanoma. The move was anticipated, but is exciting nonetheless.
Ipilimumab (Yervoy, Bristol-Myers Squibb) is the first agent to come through a phase III clinical trial showing results that stage IV melanoma patients lived longer on therapy than in the control arm.
In 2008, scientists discussed 30 years of failed melanoma trials during a session at the European Society for Medical Oncology annual congress in Stockholm. Speakers and audience members agreed that chemotherapy trials had come to a dead end in this disease. Not even dacarbazine – the standard therapy for these patients – had ever been proven better than best supportive care in a clinical trial. Another approach was needed. Desperately. And anti-CTLA-4 agents – ipilimumab and tremelimumab – were mentioned. "There are people alive who wouldn't have been without these agents," a leading investigator said in an interview at that time.
Which makes the success of this immunotherapy all the more remarkable. Ipilimumab can be highly toxic, and approval comes with a Risk Evaluation and Mitigation Strategy.
- Jane Salodof MacNeil
The FDA announced on Friday, March 25, that it had approved ipilimumab (Yervoy) for the treatment of metastatic melanoma. The move was anticipated, but is exciting nonetheless.
Ipilimumab (Yervoy, Bristol-Myers Squibb) is the first agent to come through a phase III clinical trial showing results that stage IV melanoma patients lived longer on therapy than in the control arm.
In 2008, scientists discussed 30 years of failed melanoma trials during a session at the European Society for Medical Oncology annual congress in Stockholm. Speakers and audience members agreed that chemotherapy trials had come to a dead end in this disease. Not even dacarbazine – the standard therapy for these patients – had ever been proven better than best supportive care in a clinical trial. Another approach was needed. Desperately. And anti-CTLA-4 agents – ipilimumab and tremelimumab – were mentioned. "There are people alive who wouldn't have been without these agents," a leading investigator said in an interview at that time.
Which makes the success of this immunotherapy all the more remarkable. Ipilimumab can be highly toxic, and approval comes with a Risk Evaluation and Mitigation Strategy.
- Jane Salodof MacNeil
The FDA announced on Friday, March 25, that it had approved ipilimumab (Yervoy) for the treatment of metastatic melanoma. The move was anticipated, but is exciting nonetheless.
Ipilimumab (Yervoy, Bristol-Myers Squibb) is the first agent to come through a phase III clinical trial showing results that stage IV melanoma patients lived longer on therapy than in the control arm.
In 2008, scientists discussed 30 years of failed melanoma trials during a session at the European Society for Medical Oncology annual congress in Stockholm. Speakers and audience members agreed that chemotherapy trials had come to a dead end in this disease. Not even dacarbazine – the standard therapy for these patients – had ever been proven better than best supportive care in a clinical trial. Another approach was needed. Desperately. And anti-CTLA-4 agents – ipilimumab and tremelimumab – were mentioned. "There are people alive who wouldn't have been without these agents," a leading investigator said in an interview at that time.
Which makes the success of this immunotherapy all the more remarkable. Ipilimumab can be highly toxic, and approval comes with a Risk Evaluation and Mitigation Strategy.
- Jane Salodof MacNeil