FDA Oncology Announcements

Anti-CD38 × Plasma cell × Clear all

20 Announcements

2026-03-05

FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma

Trial: MajesTEC-3
Drugs: Tecvayli (teclistamab) · Anti-BCMA-CD3 bispecific antibody, daratumumab hyaluronidase-fihj · Anti-CD38 antibody
Condition: Plasma cell

2026-01-27

FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma

Drugs: Darzalex Faspro (daratumumab and hyaluronidase-fihj) · Anti-CD38 antibody, bortezomib · Proteasome inhibitor, lenalidomide · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

2025-11-19

FDA grants traditional approval to daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis

Drugs: Darzalex Faspro (daratumumab and hyaluronidase-fihj) · Anti-CD38 antibody, bortezomib · Proteasome inhibitor
Condition: Plasma cell

2025-11-06

FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myeloma

Drug: Darzalex Faspro (daratumumab and hyaluronidase-fihj) · Anti-CD38 antibody
Condition: Plasma cell

2024-09-20

FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma

Trial: IMROZ
Drugs: Sarclisa (isatuximab-irfc) · Anti-CD38 antibody, bortezomib · Proteasome inhibitor, lenalidomide · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

2024-07-30

FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for multiple myeloma

Trial: Perseus
Drugs: Darzalex Faspro (daratumumab and hyaluronidase-fihj) · Anti-CD38 antibody, bortezomib · Proteasome inhibitor, lenalidomide · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

2021-12-01

FDA approves Darzalex Faspro, Kyprolis, and Dexamethasone for Multiple Myeloma

Drugs: Darzalex Faspro (daratumumab and hyaluronidase-fihj) · Anti-CD38 antibody, Kyprolis (carfilzomib) · Proteasome inhibitor
Condition: Plasma cell

2021-07-09

FDA approves daratumumab and hyaluronidase-fihj with pomalidomide and dexamethasone for multiple myeloma

Trial: EMN14
Drugs: Darzalex Faspro (daratumumab and hyaluronidase-fihj) · Anti-CD38 antibody, pomalidomide · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

2021-03-31

FDA approves isatuximab-irfc for multiple myeloma

Trial: IKEMA
Drugs: Sarclisa (isatuximab-irfc) · Anti-CD38 antibody, carfilzomib · Proteasome inhibitor
Condition: Plasma cell

2021-01-15

FDA grants accelerated approval to Darzalex Faspro for newly diagnosed light chain amyloidosis

Drugs: Darzalex Faspro (daratumumab plus hyaluronidase) · Anti-CD38 antibody, bortezomib · Proteasome inhibitor
Condition: Plasma cell

2020-08-20

FDA approves carfilzomib and daratumumab with dexamethasone for multiple myeloma

Trial: CANDOR
Drugs: KYPROLIS (carfilzomib) · Proteasome inhibitor, DARZALEX (daratumumab) · Anti-CD38 antibody
Condition: Plasma cell

2020-08-20

FDA approves carfilzomib and daratumumab with dexamethasone for multiple myeloma

Trial: CANDOR
Drugs: KYPROLIS (carfilzomib) · Proteasome inhibitor, DARZALEX (daratumumab) · Anti-CD38 antibody
Condition: Plasma cell

2020-05-01

FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma

Drug: DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) · Anti-CD38 antibody
Condition: Plasma cell

2020-05-01

FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma

Drug: DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) · Anti-CD38 antibody
Condition: Plasma cell

2020-03-02

FDA approves isatuximab-irfc for multiple myeloma

Trial: ICARIA-MM
Drugs: SARCLISA (isatuximab-irfc) · Anti-CD38 antibody, pomalidomide · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

2020-03-02

FDA approves isatuximab-irfc for multiple myeloma

Trial: ICARIA-MM
Drugs: SARCLISA (isatuximab-irfc) · Anti-CD38 antibody, pomalidomide · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

2019-09-26

FDA approves daratumumab for transplant-eligible multiple myeloma

Trial: Cassiopeia
Drugs: DARZALEX (daratumumab) · Anti-CD38 antibody, bortezomib · Proteasome inhibitor
Condition: Plasma cell

2019-06-27

FDA approves daratumumab for multiple myeloma ineligible for autologous stem cell transplant

Drugs: DARZALEX (daratumumab) · Anti-CD38 antibody, lenalidomide · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

2016-11-21

Daratumumab (DARZALEX)

Drugs: DARZALEX (daratumumab) · Anti-CD38 antibody, lenalidomide · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

2015-11-16

Daratumumab injection

Drug: DARZALEX (daratumumab) · Anti-CD38 antibody
Condition: Plasma cell