Janssen Announces Submission to U.S. FDA for New DARZALEX ® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma

RARITAN, NJ, February 10, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX® (daratumumab) in combination with Kyprolis® (carfilzomib) and dexamethasone (DKd) for relapsed/refractory multiple myeloma. The sBLA 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. “While we continue to make important strides in the treatment of multiple myeloma, unfortunately most patients will relapse at some point, so it is important that physicians have multiple treatment options and regimens for patients,” said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Janssen Research & Development, LLC. “The results from the CANDOR study support the potential benefit of this DARZALEX-based combination regimen for patients with multiple myeloma who have relapsed from prior treatment.” Data from the Phase 3 CANDOR study were presented as a late-breaking abstract at the 2019 American Society of Hematology (ASH) Annual Meeting. About the CANDOR Study CANDOR is a randomized, open-label Phase 3 study of DARZALEX® (daratumumab), carfilzomib and dexamethasone (DKd) compared to carfilzomib and dexamethasone (Kd) alone. ...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news