Blenrep comeback underscores FDA’s case-by-case approach to cancer approvals

FDA’s approval of Blenrep shows that when drugs fail in the late-line settings, they can still prove effective earlier in treatment or in the right combination. It also underscores the agency’s willingness to approve therapies even when there are reasons for caution.

The BCMA-targeting antibody-drug conjugate from GSK plc (LSE:GSK; NYSE:GSK) was approved as third-line therapy in combination with bortezomib and dexamethasone (BVd) to treat multiple myeloma in patients whose prior treatments include a proteasome inhibitor and an immunomodulatory agent. The decision was based on data from the Phase III DREAMM-7 study...