The European Medicines Agency has recommended new uses for 11 approved medicines, including an antibody drug conjugate for treating advanced non-small cell lung cancer.

Pink Sheet reporters and editors consider lessons and next steps after the first list of drugs subject to Medicare price negotiations was released and discuss Oncopeptides’ Pepaxto facing withdrawal under the US FDA’s new and potentially faster process.

The US FDA is free from the need to reconsider Accelerated Approvals in a formal hearing in front of an advisory committee. But now the agency is now trying that approach to hear an appeal of a rejected application.

Seeking to head off US FDA withdrawal of its alkylating agent, sponsor says pomalidomide comparator in OCEAN confirmatory trial rendered overall survival results difficult to interpret because immunomodulatory drugs are detrimental in elderly patients. CDER says IMiD analysis is exploratory and cannot negate adverse overall survival finding with Pepaxto.