Goldman Sachs Anticipates BMY Melanoma Drug Approval

Goldman Sachs expects an on time FDA approval for Bristol-Myers Squibb Company BMY ipi (renamed Yervoy) on its March 26 PDUFA for advanced melanoma in patient who have had prior therapy with REMS (second line) due to compelling data from study 020 and unmet medical need. “There is a chance that the FDA will approve for a broader label, given a lack of alternatives and a desperate young patient population (as well as positive front-line data),” Goldman Sachs writes. “This is the only melanoma study to date that has improved patient survival, with the key advantage of ipi's long tail and durability of response. Some physicians with whom we spoke to believe that a small % of patients may actually be cured. If FDA issues a CRL, which we view as unlikely, we would expect a 90 day delay as the agency may [choose] to review study 024.” Bristol-Myers Squibb closed Thursday at $26.43.