U.S. License Holder:
Janssen Biotech
Date of License:
November-16-2015
Last Update:
Dec-15-2024
FDA-Approved Indications
DARZALEX (daratumumab) is a CD38-directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma:
In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy;
In combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant;
In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant;
In combination with bortezomib and dexamethasone in patients who have received at least one prior therapy;
in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy;
In combination with pomalidomide and dexamethasone in patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor;
As monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
U.S. Patent Litigations