Drugs

FDA Approves Tibsovo for Some New AML Cases

FDA has approved Servier Pharmaceuticals’ Tibsovo (ivosidenib) in combination with azacitidine (Bristol-Myers Squibb’s Onureg) for newly-diagnosed acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test in adults age 75 or older who have comorbidities that preclude using intensive induction chemotherapy. An agency announcement says approval was based on a multi-center study of 146 patients with efficacy based on improvements in event-free survival, overall survival, and rate and duration of complete remission.

The most common adverse reactions to ivosidenib as monotherapy or in combination with azacitidine were diarrhea, fatigue, edema, nausea, vomiting, decreased appetite, leukocytosis, arthralgia, dyspnea, abdominal pain, mucositis, rash, electrocardiogram QT prolonged, differentiation syndrome, and myalgia.

The drug labeling includes a Boxed Warning for the risk of differentiation syndrome that may be life-threatening or fatal.

FDA says its review used the Real-Time Oncology Review pilot program and the Assessment Aid to approve the application about six weeks ahead of its goal date. The application was granted priority review and breakthrough designation.

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