FDA Oncology Announcements

Immunomodulatory drugs (IMiDs) × Clear all

23 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 approves epcoritamab-bysp for follicular lymphoma indications

Trial: EPCORE FL-1
Drugs: Epkinly (epcoritamab-bysp) · Anti-CD20-CD3 bispecific antibody, lenalidomide · Immunomodulatory drugs (IMiDs), rituximab · Anti-CD20 antibody
Condition: Lymphoid

FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma

Trial: InMIND
Drugs: Monjuvi (tafasitamab-cxix) · Anti-CD19 antibody, lenalidomide · Immunomodulatory drugs (IMiDs), rituximab · Anti-CD20 antibody
Condition: Lymphoid

FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma

Trial: ECHELON-3
Drugs: Adcetris (brentuximab vedotin) · Anti-CD30 antibody-drug conjugate, lenalidomide · Immunomodulatory drugs (IMiDs), rituximab · Anti-CD20 antibody
Condition: Lymphoid

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 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 grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma

Trial: L-MIND
Drugs: MONJUVI (tafasitamab-cxix) · Anti-CD19 antibody, lenalidomide · Immunomodulatory drugs (IMiDs)
Condition: Lymphoid

FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma

Trial: L-MIND
Drugs: MONJUVI (tafasitamab-cxix) · Anti-CD19 antibody, lenalidomide · Immunomodulatory drugs (IMiDs)
Condition: Lymphoid

FDA grants accelerated approval to pomalidomide for Kaposi sarcoma

Drug: POMALYST (pomalidomide) · Immunomodulatory drugs (IMiDs)
Condition: Sarcoma

FDA grants accelerated approval to pomalidomide for Kaposi sarcoma

Drug: POMALYST (pomalidomide) · Immunomodulatory drugs (IMiDs)
Condition: Sarcoma

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 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 multiple myeloma ineligible for autologous stem cell transplant

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

FDA approves lenalidomide for follicular and marginal zone lymphoma

Trials: AUGMENT, MAGNIFY
Drugs: REVLIMID (lenalidomide) · Immunomodulatory drugs (IMiDs), rituximab · Anti-CD20 antibody
Condition: Lymphoid

Daratumumab (DARZALEX)

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

Elotuzumab

Drugs: EMPLICITI (elotuzumab) · Anti-SLAMF7 antibody, lenalidomide · Immunomodulatory drugs (IMiDs)
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

FDA Approves Lenalidomide

Drug: REVLIMID (lenalidomide) · Immunomodulatory drugs (IMiDs)
Condition: Lymphoid

Pomalidomide

Drug: POMALYST capsules (pomalidomide) · Immunomodulatory drugs (IMiDs)
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