FDA Oncology Announcements

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9 Announcements

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 approves melphalan as a liver-directed treatment for uveal melanoma

Trial: FOCUS
Drug: HEPZATO KIT (melphalan) · Nitrogen mustard
Condition: Dermatologic

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

Obinutuzumab

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

Bendamustine Hydrochloride

Drug: TREANDA (bendamustine hydrochloride) · Nitrogen mustard
Condition: Lymphoid

Bendamustine Hydochloride

Drug: Treanda (bendamustine hydrochloride) · Nitrogen mustard
Conditions: Classical hematologyLymphoid

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