Posted by Michael Wonder on 20 Aug 2020
Genmab announces Janssen granted U.S. FDA approval for Darzalex (daratumumab) in combination with carfilzomib and dexamethasone in relapsed or refractory multiple myeloma
20 August 2020 - Approval marks eighth U.S. FDA approval for Darzalex.
Genmab announced today that the U.S. FDA has approved the use of Darzalex (daratumumab) in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy.
The combination has been approved in two carfilzomib dosing regimens, 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on positive results from the Phase 3 CANDOR and Phase 1b EQUULEUS studies. CANDOR was an Amgen sponsored study, co-funded by Janssen. EQUULEUS was sponsored by Janssen.
