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Hopes Rise For Approval Of Melanoma Drug Ipilimumab, With Positive Front-line Results

This article was originally published in The Pink Sheet Daily

Executive Summary

As Bristol-Myers' ipilimumab nears its March 26 PDUFA date for second-line melanoma, drug demonstrates good results in front-line study. Will the data sway regulators?

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Protecting The Blind: FDA, BMS Took Pains To Ensure Integrity Of Ongoing Yervoy Study

FDA and Bristol-Myers Squibb went to great lengths to ensure that interim overall survival data from a first-line study of Yervoy (ipilimumab) could be reviewed by the agency in a manner that maintained the trial’s blind.

Protecting The Blind: FDA, BMS Took Pains To Ensure Integrity Of Ongoing Yervoy Study

FDA and Bristol-Myers Squibb went to great lengths to ensure that interim overall survival data from a first-line study of Yervoy (ipilimumab) could be reviewed by the agency in a manner that maintained the trial’s blind.

Yervoy Approval Has Shifted Development Landscape For Melanoma

With Bristol-Myers Squibb Co.’s ipilimumab cleared and Roche/Daiichi Sankyo’s BRAF inhibitor vemurafenib (RG7204) on track for a filing and perhaps approval this year, companies developing other melanoma drugs face a more complicated, competitive path to market.

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