FDA Oncology Announcements

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18 Announcements

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 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 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 isatuximab-irfc for multiple myeloma

Trial: IKEMA
Drugs: Sarclisa (isatuximab-irfc) · Anti-CD38 antibody, carfilzomib · Proteasome inhibitor
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 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 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 approves daratumumab for transplant-eligible multiple myeloma

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

Ixazomib

Drugs: NINLARO (ixazomib) · Proteasome inhibitor, lenalidomide · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

Carfilzomib /Kyprolis

Drugs: Kyprolis (carfilzomib) · Proteasome inhibitor, lenalidomide · Immunomodulatory drugs (IMiDs)
Condition: Plasma cell

Panobinostat

Drugs: FARYDAK capsules (panobinostat) · HDAC inhibitor, bortezomib · Proteasome inhibitor
Condition: Plasma cell

Carfilzomib

Drug: Kyprolis (carfilzomib) · Proteasome inhibitor
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 bortezomib (Velcade) for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy

Drug: VELCADE (bortezomib) · Proteasome inhibitor
Condition: Lymphoid