Drugs

Agios Pharma’s Tibsovo Approved for Leukemia

FDA has approved an Agios Pharmaceuticals NDA for Tibsovo (ivosidenib) tablets for treating adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first isocitrate dehydrogenase-1 inhibitor approved for use with an FDA-approved companion diagnostic (Abbott’s RealTime IDH1 Assay) used to detect specific mutations in the IDH1 gene in patients with AML.

Tibsovo works by decreasing abnormal production of the oncometabolite 2-hydroxyglutarate, leading to differentiation of malignant cells, an agency release says. Its efficacy was demonstrated in a single-arm trial of 174 adult patients with relapsed or refractory AML with an IDH1 mutation. With a median follow-up of 8.3 months, 32.8% of patients experienced a complete remission or complete remission with partial hematologic recovery that lasted a median 8.2 months, it says. “Of the 110 patients who required transfusions of blood or platelets due to AML at the start of the study, 37% went at least 56 days without requiring a transfusion after treatment with Tibsovo,” it adds.

Common side effects of Tibsovo include fatigue, increase in white blood cells, joint pain, diarrhea, shortness of breath, swelling in the arms or legs, nausea, pain or sores in the mouth or throat, irregular heartbeat (QT prolongation), rash, fever, cough and constipation. Women who are breastfeeding should not take Tibsovo because it may cause harm to a newborn baby. Additionally, Tibsovo must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks.

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