daratumumab (Darzalex)

^[1]^[2]^[3]^[4]

Indications

multiple myeloma
- in combination with lenalidomide & dexamethasone, or bortezomib & dexamethasone (at least one prior therapy)
- in combination with pomalidomide & dexamethasone (at least two prior therapies including lenalidomide & a proteasome inhibitor)
- as monotherapy (at least three prior lines of therapy including a proteasome & an immunomodulatory agent & double refractory to proteasome inhibitor & immunomodulatory agent)^[3]
ANCA-associated vasculitis^[4]

* daratumumab combined with bortezomib, melphalan, & prednisone reduces risk of disease progression or death in patients with stem-cell ineligible multiple myeloma than same regimen without daratumumab^[2]

other

may interfere with blood bank antibody screening tests
- erythrocytes express CD-38
- CD38 with daratumumab bound may result in a false-positive indirect Coombs test^[3]

↑ FDA News Release. November 16, 2015 FDA approves Darzalex for patients with previously treated multiple myeloma http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm472875.htm
↑ ^2.0 ^2.1 ^2.2 Mateos MV, Dimopoulos MA, Cavo M et al Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. N Engl J Med. Dec 12, 2017 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/29231133 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1714678
↑ ^3.0 ^3.1 ^3.2 Minerd J with Expert Critique from Short NJ Tips for Using Daratumumab. What clinicians should know about this new option for multiple myeloma. MedPage Today. ASCO Reading Room. March 14, 2018 https://www.medpagetoday.com/reading-room/asco/hematologic-malignancies/71748
↑ ^4.0 ^4.1 Rixecker TM, Leppervpm, Mang S et al Daratumumab for a Patient With Refractory Antineutrophil Cytoplasmatic Antibody- Associated Vasculitis. JAMA Intern Med. Published online April 10, 2023 PMID: https://www.ncbi.nlm.nih.gov/pubmed/37036724 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2803783