FDA expands approval of Kyprolis to include combination with Darzalex Faspro and dexamethasone.

The expansion of the Kyprolis prescribing information to include Darzalex Faspro plus dexamethasone was supported by the ongoing, Phase 2, non-randomized, open-label, multicenter PLEIADES trial evaluating the clinical benefit of Darzalex Faspro administered in combination with four standard-of-care treatment regimens in patients with multiple myeloma.

Updated data from the PLEIADES study were presented at the 2020 American Society of Hematology (ASH) Annual Meeting, demonstrating that response rates with Kyprolis in combination with Darzalex Faspro and dexamethasone were similar to those in the Phase III CANDOR study (Kyprolis combined with intravenous [IV] Darzalex and dexamethasone [DKd]), which supported the first-ever approval of an anti-CD38 monoclonal antibody in combination with Kyprolis. The PLEIADES study met its primary endpoint, demonstrating an overall response rate of 84.8 percent with Darzalex Faspro-Kd.