The US Food and Drug Administration (FDA) has approved use of recombinant human interleukin 11 (rhIL-11; oprelvekin; Neumega - Genetics Institute) to increase platelet counts and decrease the need for platelet transfusions in patients with severe thrombocytopenia caused by chemotherapy for nonmyeloid malignancies.

Obinutuzumab (Gazyva – Genentech), a humanized anti-CD20 monoclonal antibody, has been approved by the FDA for use in combination with chlorambucil (Leukeran) in patients with previously untreated chronic lymphocytic leukemia (CLL). Two other anti-CD20 antibodies, rituximab (Rituxan) and ofatumumab (Arzerra), were previously approved for treatment of CLL.

Bendamustine HCl (Treanda - Cephalon), an unusual DNA-alkylating agent that has been used in Europe for many years to treat lymphoma, has now been approved by the FDA for treatment of chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL).

Ondansetron (on dan' se tron; Zofran - Glaxo), a serotonin (5-hydroxytryptamine) antagonist, was recently marketed in the USA for intravenous use to prevent nausea and vomiting due to cancer chemotherapy. An oral formulation is available in many other countries.

Intensive chemotherapy, with or without total body radiation, followed by bone marrow transplantation is now widely used in the treatment of malignant diseases. The drugs and radiation needed to try to eradicate the malignancy unavoidably destroy the bone marrow; intravenous infusion of bone marrow cells restores the marrow by repopulating it. Diseases for which bone marrow transplantation has been used include the leukemias and lymphomas, breast cancer, neuroblastoma, ovarian cancer, germ cell tumors, melanoma, multiple myeloma, and malignant gliomas (NC Gorin, Am J Clin On-col, 14...

Glofitamab-gxbm (Columvi – Genentech), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for IV treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, or large B-cell lymphoma (LBCL) arising from follicular lymphoma after ≥2 lines of systemic therapy. Accelerated approval was based on response rates and durability of response. Glofitamab is the second T-cell-engaging bispecific antibody to be approved in the US for treatment of DLBCL; epcoritamab-bysp (Epkinly), which is given...

Eflapegrastim-xnst ((Rolvedon) [Spectrum]; previously called Rolontis), a granulocyte colony-stimulating factor (G-CSF) conjugated to an Fc fragment of human IgG4, has been approved by the FDA to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive chemotherapy that can cause clinically significant febrile neutropenia.

Caplacizumab-yhdp (Cablivi – Sanofi /Genzyme), a von Willebrand factor-directed antibody fragment, has been approved by the FDA for use in combination with plasma exchange and immunosuppressive therapy for treatment of immune-mediated thrombotic thrombocytopenic purpura (iTTP; formerly called acquired thrombotic thrombocytopenic purpura [aTTP]) in adults. It is the first drug to be approved in the US for this indication.

The FDA has approved anifrolumab-fnia (Saphnelo – AstraZeneca), a type I interferon receptor antagonist, for IV treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard treatment. Anifrolumab has not been studied in patients with severe active lupus nephritis or severe active CNS lupus. It is the first type I interferon receptor antagonist to become available in the US.

The FDA has approved idelalisib (Zydelig – Gilead), an oral kinase inhibitor, for use in combination with rituximab (Rituxan) for treatment of relapsed chronic lymphocytic leukemia (CLL). It is also approved as monotherapy for treatment of relapsed follicular lymphoma and relapsed small lymphocytic lymphoma (both are subtypes of indolent non-Hodgkins lymphoma) in patients who have received at least two prior systemic therapies.