Approval or bust

Following the failure of a Phase III trial that was the first-ever controlled study of etirinotecan pegol in breast cancer, Nektar Therapeutics is getting ready to roll the dice with regulators. The company will argue that its lead internal program should be added to the armamentarium for metastatic breast cancer based on improved tolerability in the study population at large, and a survival advantage in two prespecified subgroups.

If that doesn't work, the compound will be canned...