Darzalex + bortezomib, thalidomide and dexamethasone submitted to FDA for multiple myeloma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA seeking approval of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant (ASCT). The Phase III CASSIOPEIA (MMY3006) clinical study, which supports the sBLA submission, met its primary endpoint – the proportion of patients that achieved stringent Complete Response (sCR) after induction and consolidation therapy.

In the first part of the study, patients were randomized to receive induction treatment with VTd alone or in combination with Darzalex, high-dose therapy and ASCT, and consolidation therapy with VTd alone or in combination with Darzalex. The primary endpoint in this part of the study is the proportion of patients who achieve a sCR. In the second part of the study, which is ongoing, patients who achieved a partial response or better in part one will undergo a second randomization to receive maintenance treatment with Darzalex 16 mg/kg every eight weeks for up to two years or be observed with no further treatment. The primary endpoint in this part of the study is progression-free survival.