Trastuzumab Biosimilar Approved for Breast Cancer

Trastuzumab-pkrb (Herzuma®, Celltrion Inc.) has recently been FDA-approved to treat human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer. Trastuzumab-pkrb is a biosimilar to trastuzumab (Herceptin®, Genentech Inc.). Biosimilars—biological agents made from living organisms—are almost identical to another biological agent that has already been FDA-approved, known as the reference drug. Biosimilars and their reference drugs may differ in production and composition; however, ...
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Atezolizumab Approved for Metastatic Nonsquamous NSCLC

After granting Priority Review, the FDA has approved atezolizumab (Tecentriq®, Genentech, Inc.), a monoclonal antibody, to be used in combination with carboplatin/paclitaxel/bevacizumab (CPB) for patients with previously untreated metastatic nonsquamous, non-small cell lung cancer (NSCLC) without EGFR or ALK tumor mutations. The approval was based on the open-label, three-arm IMpower150 trial (NCT02366143), for which patients were randomized 1:1:1 to a regimen of atezolizumab plus CPB, a regimen...
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Glasdegib Approved to Treat Acute Myeloid Leukemia

Recently, the FDA approved glasdegib (DaurismoÔ, Pfizer Labs) to be used in combination with low-dose cytarabine (LDAC) for newly diagnosed acute myeloid leukemia (AML) in elderly patients or those ineligible to receive intensive induction chemotherapy. Richard Pazdur, MD, Director of the FDA's Oncology Center of Excellence and Acting Director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, explained, "Intensive chemotherapy is usually used...
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Venetoclax Combination Approved for Acute Myeloid Leukemia

The FDA has approved venetoclax (VenclextaÒ, AbbVie Inc. and Genentech Inc.) to be used in combination with azacitidine, decitabine, or low-dose cytarabine for the treatment of acute myeloid leukemia (AML) in elderly patients or those ineligible for intensive chemotherapy. Approval of venetoclax was determined based on two open-label, non-randomized trials involving patients with newly diagnosed AML aged 75 years or older or with comorbidities that prevent them from receiving intensive induction...
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Brentuximab Vedotin Approved in Peripheral T-Cell Lymphomas

The FDA has expanded the approval of brentuximab vedotin (Adcetris®, Seattle Genetics, Inc.) in combination with chemotherapy as a first-line treatment for adults with systemic anaplastic large cell lymphoma (ALCL) and other peripheral T-cell lymphomas (PTCLs) expressing the tumor marker CD30. This is the first FDA-approved treatment for patients with newly diagnosed PTCLs. Peripheral T-cell lymphomas are a diverse group of rare non-Hodgkin lymphomas that result when the immune system's T cells ...
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