Drugs

FDA Approves Jazz’ Vyxeos for 2 AML Cancers

FDA has approved Jazz Pharmaceuticals’ Vyxeos, a fixed combination of daunorubicin and cytarabine, for treating adults with two types of acute myeloid leukemia (AML). The agency says in a news release that the two types are newly diagnosed therapy-related AML (t-AML) and AML with myelodysplasia-related changes (AML-MRC). The release says it is the first approved treatment specifically for patients with certain types of high-risk AML.

Vyxeos’ efficacy and safety were studied in 309 patients with newly-diagnosed t-AML or AML-MRC, who were randomized to receive Vyxeos or separately administered treatments of daunorubicin and cytarabine. The agency says that patients who received Vyxeos lived longer than patients who received separate treatments of the two drugs.

Common side effects of Vyexos are reported as hemorrhage, febrile neutropenia, rash, edema, nausea, mucositis, diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, dyspnea, headache, cough, decreased appetite, arrhythmia, pneumonia, bacteremia, chills, sleep disorders, and vomiting.

Labeling for the drug includes a Boxed Warning not to interchange Vyexos with other daunorubicin- and/or cytarabine-containing products.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome