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Bristol-Myers Squibb withdraws lung cancer combo therapy marketing application

Published on 25/01/19 at 10:16am

Bristol-Myers Squibb has been forced to withdraw a marketing application for its combination of Opdivo and Yervoy for lung cancer.

The US firm withdrew the marketing application for the combination of PD-1 inhibitor Opdivo (nivolumab) and CTLA4 inhibitor Yervoy (ipilimumab), after a request from the FDA for more data.

As the marketing application cannot be delayed, BMS was forced to withdraw the marketing application and will re-file later.

The move has come after the FDA asked for more information on the relationship on the particular biomarker associated with the therapy and overall survival.

“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 NSCLC 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 tumors express PD-L1), which the company anticipates will be available in the first-half of 2019,” the company said in a statement.

Sales of Bristol’s Opdivo have fallen behind those of Merck’s Keytruda which surpassed sales of BMS’ immunotherapy drug in the second quarter of last year.

Analysts have speculated that BMS’ recently announced acquisition of Celgene may be an attempt to boost the firm’s standing in the highly lucrative lung cancer market.

Louis Goss

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