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...

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...

The FDA has approved venetoclax (Venclexta Ò , 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 inducti...

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 ...

Patients with advanced hepatocellular carcinoma (HCC) who have progressed on sorafenib can now take FDA-approved pembrolizumab (Keytruda â , 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 a...