Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.

US FDA is reviewing confirmatory trial data that suggest a ‘detriment in survival’ with Oncopeptides’ alkylating agent in relapsed/refractory multiple myeloma and may convene its Oncologic Drugs Advisory Committee to explore continued marketing for patients who received at least four prior lines of therapy.

Oncopeptides AB’s melflufen (Pepaxto) has met the primary PFS endpoint in the Phase III OCEAN study, designed to extend its reach into earlier-stage multiple myeloma patients, but overall survival data favors the comparator in patient subgroups, and melflufen in others, leading to regulators pausing clinical trials to review the results.

The European Medicines Agency will decide this week whether BMS and bluebird bio’s cell-based gene therapy for multiple myeloma should be approved for use in the EU.