Posted by Michael Wonder on 11 Feb 2020
Janssen announces submission to U.S. FDA for new Darzalex (daratumumab)-based combination regimen for patients with relapsed/refractory multiple myeloma
10 February 2020 - Application is based on positive data from the Phase 3 CANDOR study, which were presented at the 2019 American Society of Hematology Annual Meeting.
Janssen announced today the submission of a supplemental biologics license application to the U.S. FDA seeking approval of Darzalex (daratumumab) in combination with Kyprolis (carfilzomib) and dexamethasone (DKd) for relapsed/refractory multiple myeloma.
The application is supported by results from the Phase 3 CANDOR study, which compared treatment with DKd to carfilzomib and dexamethasone (Kd) in patients with multiple myeloma who relapsed after one to three prior lines of therapy.
