History of Daratumumab

• Daratumumab (Darzalex) falls under the anti-cancer medication. It is involved in order to bind to the CD38, which is overexpressed in the multiple myeloma cells.

• It was originated by Genmab, but it is currently being jointly developed by Genmab along with the J&J subsidiary named Janssen Biotech, which acquired the global commercialization rights to the Daratumumab from Genmab.

• In the month of August, 2012, Janssen Biotech announced the agreement of Global License and Development for investigational anti cancer agent daratumumab. 

• In the month of May, 2013, daratumumab received breakthrough therapy designation in the double refractory MM from the U.S. FDA. 

• In the month of February, 2015, Genmab has announced the preliminary outcomes in phase-II study of daratumumab in the double refractory multiple myeloma.

• In the month of June, 2015,  Janssen initiated the rolling submission of BLA for daratumumab in order to treat patients with multiple myeloma. 

• In the month of September 2015, the FDA granted priority review to Janssen for daratumumab as a treatment option for MM (Multiple Myeloma). 

• In the month of November, 2015, the FDA approved daratumumab in order to treat patients with previously treated multiple myeloma. 

• In the month of November, 2016, the FDA approved daratumumab together with two standard of care regimens in order to treat patients with multiple myeloma who have taken at least 1 prior therapy. 

• In the month of June, 2017, the FDA approved daratumumab together with pomalidomide and dexamethasone for patients with RRMM (Relapsed/Refractory Multiple Myeloma). 

• In the month of May, 2018, the FDA approved daratumumab for newly diagnosed patients with MM who are basically the transplant ineligible. 

• In the month of February, 2019, the FDA approved daratumumab split-dosing regimen. 

• In the month of June, 2019, the FDA approved daratumumab together with lenalidomide and dexamethasone for newly diagnosed multiple myeloma patients who are basically transplant ineligible. 

• In the month of September, 2019 the FDA approved daratumumab combination regimen for the newly diagnosed, transplant eligible multiple myeloma patients. 

• In the month of May, 2020, the FDA approved daratumumab and hyaluronidase in order to treat patients with Multiple Myeloma. 

• In the month of August, 2020, the FDA approved a new carfilzomib combination regimen together with daratumumab and dexamethasone in both once and twice weekly dosing regimens. 

• The daratumumab cost in india is around 75,000 INR for a supply of vial of one injection, depending on the pharmacy/wholesaler you visit. Any WHO-GDP & ISO certified pharmaceutical wholesaler company would be best to buy daratumumab.