Date: 2018-08-08
Type of information: Submission of an sNDA
Product name: Darzalex®
Compound: daratumumab
Therapeutic area: Cancer - Oncology
Action mechanism:
- monoclonal antibody. Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma. It targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells and may also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma. In May, 2013, daratumumab has been granted Breakthrough Therapy Designation from the FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab. With the exception of one study sponsored globally by the French multiple myeloma cooperative group, Intergroupe Francophone du Myelome (IFM), Janssen is the global sponsor of all current and future clinical studies for daratumumab.
Company: Janssen Biotech, a J&J company (USA - NJ)
Disease: split dosing regimen
Latest news:
- • On August 8, 2018, Genmab announced that its licensing partner, Janssen Biotech has submitted a supplemental Biologics License Application (sBLA) to the FDA and a Type II Variation to the European Medicines Agency (EMA) seeking approval of a split dosing regimen for Darzalex® (daratumumab). The applications request to update the Prescribing Information and Summary of Product Characteristics in order to provide health care professionals the option of splitting the first infusion of Darzalex® over two consecutive days.
- The submissions are supported by data from the Phase Ib EQUULEUS (MMY1001) clinical trial, which demonstrated Darzalex® pharmacokinetics (PK) concentrations were comparable regardless of whether the first dose was administered as a split infusion or as a single first infusion in patients with multiple myeloma. The safety profile of Darzalex® was comparable when administered initially as either a split or a single dose. The Phase Ib EQULLEUS open-label study includes up to 240 patients with the goal of evaluating the safety, tolerability and dose of daratumumab when administered in combination with various backbone treatment regimens for different settings of multiple myeloma.
Patents:
Submission of marketing authorization application USA : 2018-08-08
Submission of marketing authorization application UE: 2018-08-08
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
