BMS Withdraws sBLA Due to Overall Survival Data Request

Based on recent discussions with FDA, Bristol-Myers Squibb has withdrawn a supplemental BLA for an indication in metastatic first-line non-small cell lung cancer for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) in patients with tumor mutational burden (TMB) greater or equal to 10 mutations/megabase. The agency strongly urged the withdrawal because it wants to see final study data on overall survival from the Checkmate -227, Part 1a study (Opdivo plus low-dose Yervoy or Opdivo monotherapy versus chemotherapy in patients whose tumors express PD-L1).

BMS says the data should be available in the first-half of the year, and since the data will not be available within the current review cycle it decided to withdraw the submission. In October, FDA had extended its review after the company submitted an overall survival analysis for the TMB <10 mut/Mb subgroup as requested by the agency (see story). Then, the user fee review action target was extended to 5/20/2019.