FDA Oncology Announcements

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29 Announcements

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

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

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

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

FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma

Trial: DREAMM 7
Drug: Blenrep (belantamab mafodotin-blmf) · Anti-BCMA antibody-drug conjugate
Condition: Plasma cell

FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma

Trial: LINKER-MM1
Drug: Lynozyfic (linvoseltamab-gcpt) · Anti-BCMA-CD3 bispecific antibody
Condition: Plasma cell

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

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

FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma

Drug: Elrexfio (elranatamab-bcmm) · Anti-BCMA-CD3 bispecific antibody
Condition: Plasma cell

FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma

Trials: MonumenTAL-1, MonumenTAL-1
Drug: Talvey (talquetamab-tgvs) · Anti-GPRC5D-CD3 bispecific antibody
Condition: Plasma cell

FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma

Trials: MajesTEC-1, MajesTEC-1
Drug: Tecvayli (teclistamab-cqyv) · Anti-BCMA-CD3 bispecific antibody
Condition: Plasma cell

FDA approves ciltacabtagene autoleucel for relapsed or refractory multiple myeloma

Trial: CARTITUDE-1
Drug: CARVYKTI (ciltacabtagene autoleucel) · Anti-BCMA CAR T-cell
Condition: Plasma cell

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

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

FDA approves isatuximab-irfc for multiple myeloma

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

FDA approves idecabtagene vicleucel for multiple myeloma

Drug: Abecma (idecabtagene vicleucel) · Anti-BCMA CAR T-cell
Condition: Plasma cell

FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma

Trial: HORIZON
Drug: Pepaxto (melphalan flufenamide) · Peptidase-enhanced nitrogen mustard
Condition: Plasma cell

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

FDA approves selinexor for refractory or relapsed multiple myeloma

Trial: BOSTON
Drugs: XPOVIO (selinexor) · XPO1 inhibitor, bortezomib · Proteasome inhibitor
Condition: Plasma cell

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

FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma

Drug: Blenrep (belantamab mafodotin-blmf) · Anti-BCMA antibody-drug conjugate
Condition: Plasma cell

FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma

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

FDA approves isatuximab-irfc for multiple myeloma

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

FDA approves daratumumab for transplant-eligible multiple myeloma

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

FDA grants accelerated approval to selinexor for multiple myeloma

Trial: STORM
Drug: XPOVIO (selinexor) · XPO1 inhibitor
Condition: Plasma cell

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

Velcade (bortezomib) is Approved for Initial Treatment of Patients with Multiple Myeloma

Drugs: Velcade (bortezomib) · Proteasome inhibitor, Velcade (injection)
Condition: Plasma cell

FDA approves lenalidomide oral capsules (Revlimid) for use in combination with dexamethasone in patients with multiple myeloma

Drug: Revlimid (lenalidomide) · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

FDA Approves Thalomid (thalidomide) to Treat Multiple Myeloma

Drug: Thalomid (thalidomide) · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell