EC grants marketing authorization for Removab as a treatment for malignant ascites

FDA approves Adcetris + lenalidomide + rituximab for r/r large B-cell lymphoma

FDA approved Adcetris (brentuximab vedotin) in combination with lenalidomide and a rituximab product for adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.

February 14, 2025

Vol.51 No.06

Drugs & Targets

FDA approves Gomekli for pediatric patients with neurofiromatosis type 1

FDA approved Gomekli (mirdametinib), a kinase inhibitor from SpringWorks Therapeutics, for adult and pediatric patients two years of age and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection.

February 14, 2025

Vol.51 No.06

Drugs & Targets

FDA approves Enhertu as first HER2-directed therapy for breast cancer

FDA approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic hormone receptor-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by the FDA approved test, that has progressed on one or more endocrine therapies in the metastatic setting.

January 31, 2025

Vol.51 No.04

Drugs & Targets

FDA approves Grafapex as preparative regiment for allogeneic hematopoietic stem cell transplantation in AML or MDS

FDA approved Grafapex (treosulfan), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients one year of age and older with acute myeloid leukemia or myelodysplastic syndrome on Jan. 22.

January 31, 2025

Vol.51 No.04

Drugs & Targets

EU, China approve Sarclisa + standard of care for MM

The EU has approved Sarclisa (isatuximab-irfc) in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma ineligible for autologous stem cell transplant, based on data from the IMROZ phase III study.

January 24, 2025

Vol.51 No.03

Drugs & Targets

EC approves Opdivo + Yervoy as first-line treatment for MSI-H or dMMR metastatic CRC

The European Commission has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer.

January 10, 2025

Vol.51 No.01

EC grants marketing authorization for Removab as a treatment for malignant ascites

YOU MAY BE INTERESTED IN

FDA approves Adcetris + lenalidomide + rituximab for r/r large B-cell lymphoma

FDA approves Gomekli for pediatric patients with neurofiromatosis type 1

FDA approves Enhertu as first HER2-directed therapy for breast cancer

FDA approves Grafapex as preparative regiment for allogeneic hematopoietic stem cell transplantation in AML or MDS

EU, China approve Sarclisa + standard of care for MM

EC approves Opdivo + Yervoy as first-line treatment for MSI-H or dMMR metastatic CRC

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