Yervoy Survival Data From First-Line Study Sealed The Deal For FDA Approval

FDA’s approval of Bristol-Myers Squibb’s metastatic melanoma immunotherapy was granted only after looking outside the BLA for assurance that the biologic’s effect was robust and validated.

FDA’s approval of Bristol-Myers Squibb Co.'s metastatic melanoma immunotherapy Yervoy (ipilimumab) was granted only after looking outside the BLA for assurance that the biologic’s effect was robust and validated.

Faced with an application for a second-line indication and a single study showing a survival benefit, but with only modest...

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