Daratumumab and hyaluronidase (Darzalex Faspro)

==General information==
Class/mechanism: Anti-CD38 antibody, human monoclonal IgG1 kappa. Daratumumab binds to CD38 and causes apoptosis in CD38-expressing cells via Fc mediated cross-linking, complement-dependent cytotoxicity (CDC), antibody-dependent cell mediated cytotoxicity (ADCC), and antibody dependent cellular phagocytosis (ADCP). CD38 is present on the cell surface of multiple myeloma (MM), plasma leukemia, and natural killer (NK) cells.Daratumumab and hyaluronidase (Darzalex Faspro) package insert Daratumumab and hyaluronidase (Darzalex Faspro) package insert (locally hosted backup)Darzalex Faspro manufacturer's website
Route: SC
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information. 
==Diseases for which it is used==
*Light-chain (AL) amyloidosis
*Multiple myeloma
==Patient drug information==
*Daratumumab and hyaluronidase (Darzalex Faspro) package insert
==History of changes in FDA indication==
===Light-chain (AL) amyloidosis===
*2021-01-15: Accelerated approval in combination with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light-chain (AL) amyloidosis. (New disease entity; based on ANDROMEDA)
===Multiple myeloma===
*2020-05-01: Approved for adult patients with newly diagnosed or relapsed/refractory multiple myeloma in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant. (Based on PLEIADES)
*2020-05-01: Approved for adult patients with newly diagnosed or relapsed/refractory 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. (Based on PLEIADES)
*2020-05-01: Approved for adult patients with newly diagnosed or relapsed/refractory multiple myeloma in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy. (Based on COLUMBA)
*2020-05-01: Approved for adult patients with newly diagnosed or relapsed/refractory multiple myeloma as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. (Based on COLUMBA)
*2021-07-09: Approved in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. (Based on APOLLO)
*2021-11-30: Approved for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. (Based on PLEIADES)
*2024-07-30: Approved in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). (Based on PERSEUS)
==Also known as==
*Generic name: daratumumab and hyaluronidase-fihj
*Brand name: Darzalex Faspro
==References==
Category:Drugs
Category:Subcutaneous medications
Category:Anti-CD38 antibodies
Category:Light-chain (AL) amyloidosis medications
Category:Multiple myeloma medications
Category:FDA approved in 2020