FDA Oncology Announcements

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25 Announcements

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 acalabrutinib with bendamustine and rituximab for previously untreated mantle cell lymphoma

Drugs: Calquence (acalabrutinib) · BTK inhibitor, bendamustine · Nitrogen mustard, rituximab · Anti-CD20 antibody
Condition: Lymphoid

FDA grants accelerated approval to zanubrutinib for relapsed or refractory follicular lymphoma

Trial: ROSEWOOD
Drugs: Brukinsa (zanubrutinib) · BTK inhibitor, obinutuzumab · Anti-CD20 antibody
Condition: Lymphoid

FDA approves polatuzumab vedotin-piiq for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma

Trial: POLARIX
Drugs: Polivy (polatuzumab vedotin-piiq) · Anti-CD79B antibody-drug conjugate, rituximab · Anti-CD20 antibody
Condition: Lymphoid

FDA approves rituximab plus chemotherapy for pediatric cancer indications

Drug: Rituxan (rituximab) · Anti-CD20 antibody
Condition: Other neoplasm

FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia

Drugs: IMBRUVICA (ibrutinib) · BTK inhibitor, rituximab · Anti-CD20 antibody
Conditions: LymphoidOther hematologic neoplasm

FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia

Drugs: IMBRUVICA (ibrutinib) · BTK inhibitor, rituximab · Anti-CD20 antibody
Conditions: LymphoidOther hematologic neoplasm

FDA approves polatuzumab vedotin-piiq for diffuse large B-cell lymphoma

Drugs: POLIVY (polatuzumab vedotin-piiq) · Anti-CD79B antibody-drug conjugate, bendamustine · Nitrogen mustard, rituximab · Anti-CD20 antibody
Condition: Lymphoid

FDA approves lenalidomide for follicular and marginal zone lymphoma

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

FDA approves Truxima as biosimilar to Rituxan for non-Hodgkin’s lymphoma

Drugs: Truxima (rituximab-abbs) · Anti-CD20 antibody, Rituxan (rituximab) · Anti-CD20 antibody
Condition: Lymphoid

FDA approves obinutuzumab for previously untreated follicular lymphoma

Drug: GAZYVA (obinutuzumab) · Anti-CD20 antibody
Condition: Lymphoid

FDA approves rituximab plus hyaluronidase combination for Treatment of FL, DLBCL and CLL

Drug: RITUXAN HYCELA (rituximab and hyaluronidase human) · Anti-CD20 antibody
Condition: Lymphoid

Obinutuzumab

Drugs: Gazyva (obinutuzumab) · Anti-CD20 antibody, chlorambucil · Nitrogen mustard
Condition: Lymphoid

Ofatumumab (Arzerra Injection)

Drug: Arzerra (ofatumumab) · Anti-CD20 antibody
Condition: Lymphoid

Idelalisib

Drugs: Zydelig tablets (idelalisib) · PI3K delta inhibitor, rituximab · Anti-CD20 antibody
Condition: Lymphoid

FDA Approves Ofatumumab

Drugs: Arzerra (ofatumumab) · Anti-CD20 antibody, chlorambucil · Nitrogen mustard
Condition: Lymphoid

Gazyva (obinutuzumab)

Drugs: GAZYVA (obinutuzumab) · Anti-CD20 antibody, chlorambucil · Nitrogen mustard
Condition: Lymphoid

Rituximab Infusion

Drug: Rituxan (rituximab) · Anti-CD20 antibody
Condition: Lymphoid

Rituximab 2011

Drug: Rituxan (rituximab) · Anti-CD20 antibody
Condition: Lymphoid

Rituximab

Drug: Rituxan (rituximab) · Anti-CD20 antibody
Condition: Lymphoid

Ofatumumab

Drug: Arzerra (ofatumumab) · Anti-CD20 antibody
Condition: Lymphoid

FDA approves two rituximab (Rituxan) supplemental applications for the first-line treatment of patients with low grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma

Drug: Rituxan (rituximab) · Anti-CD20 antibody
Condition: Lymphoid

FDA approves rituximab (Rituxan) for use in the first‑line treatment of patients with diffuse large B-cell, CD20‑positive, non-Hodgkin's lymphoma in combination with CHOP or other anthracycline‑based chemotherapy regimens

Drugs: Rituxan (rituximab) · Anti-CD20 antibody, cyclophosphamide · Nitrogen mustard
Condition: Lymphoid