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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Pembrolizumab Granted Approval for Hepatocellular Carcinoma

Patients with advanced hepatocellular carcinoma (HCC) who have progressed on sorafenib can now take FDA-approved pembrolizumab (Keytrudaâ, Merck & Co., Inc.). Approval was based on KEYNOTE 224 (NCT02702414), a single-arm, multicenter trial which enrolled 104 patients with HCC. For trial eligibility, patients were required to have disease progression on or after using sorafenib, measurable disease, and Child-Pugh Class A liver impairment. Patients were administered 200 mg of pembrolizumab as ...
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Lorlatinib Approved for ALK-Positive Metastatic NSCLC

Lorlatinib (Lorbrena®, Pfizer, Inc.) is approved as second- or third-line treatment for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. FDA approval was granted based on a non-randomized, dose-ranging and activity-estimating, ...
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Talazoparib Approved: Advanced HER2-Negative Breast Cancer With gBRCA Mutations

​Talazoparib (Talzenna®, Pfizer Inc.), an orally available poly (ADP-ribose) polymerase (PARP) inhibitor, has been approved by the United States Food and Drug Administration (FDA) for the treatment of patients with HER2-negative locally advanced or metastatic breast cancer with known or suspected deleterious germline BRCA (gBRCA) mutations. Eligibility for talazoparib therapy must be determined using the BRACAnalysis CDx® test (Myriad Genetic Laboratories Inc.), which the FDA has also approved a...
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