Posted by Michael Wonder on 24 Jan 2019
BMS announces voluntary withdrawal of U.S. application for Opdivo plus low dose Yervoy for treatment of first-line lung cancer in patients with tumor mutational burden ≥10 mutations/megabase, following discussions with the U.S. FDA
24 January 2019 - Following recent discussions with the U.S. FDA, the company today announced the voluntary withdrawal of the U.S. supplemental biologics license application for the Opdivo and low-dose Yervoy (ipilimumab) combination for treatment of first-line advanced non-small cell lung cancer in patients with tumour mutational burden ≥10 mutations/megabase (mut/Mb).
In October 2018, the company announced the submission of an exploratory overall survival (OS) analysis for the tumour mutation burden (TMB) <10 mut/Mb subgroup to the FDA. The FDA determined at that time, that the submission of this new information constituted a major amendment to the applcation and extended the review period by three months, moving the Prescription Drug User Fee Act date to May 20, 2019.
After recent discussions with the FDA, the company believes further evidence on the relationship between TMB and PD-L1 is required to fully evaluate the impact of Opdivo plus Yervoy on OS in first-line non-small cell lung cancer patients. This analysis will require availability of the final data from Checkmate -227, Part 1a (Opdivo plus low-dose Yervoy or Opdivo monotherapy versus chemotherapy in patients whose tumours express PD-L1), which the company anticipates will be available in the first-half of 2019. Since these data from Checkmate -227, Part 1a, will not be available within the review cycle of the current application the company decided to withdraw.
