Following a string of victories at the FDA, Bristol-Myers Squibb’s Opdivo finally has encountered a regulatory roadblock in the form of a complete response letter.
BMS has been seeking FDA approval for Opdivo (nivolumab) as a single agent for the treatment of previously untreated patients with BRAF V600 mutation positive unresectable or metastatic melanoma. The drug had been on somewhat of a roll, snagging FDA approvals last week for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma, as well as for those with advanced renal cell carcinoma who have received prior therapy.
The company says it will work with the FDA to determine whether data currently under review will address the agency’s concerns.
BMS hopes to announce more good news for Opdivo by early next year. It has submitted an sBLA for the drug as a single agent and in combination with Yervoy (ipilimumab) to treat patients with previously untreated advanced melanoma. The target action date is Jan. 23, 2016.