Drugs

FDA Approves New Tibsovo Indication

FDA has approved a new indication for Servier Pharmaceuticals’ Tibsovo (ivosidenib) to treat adults with relapsed or refractory (R/R) myelodysplastic syndromes (MDS) with an isocitrate dehydrogenase-1 (IDH-1) mutation as detected by an FDA-approved test. An agency statement says this is the first targeted therapy approved for this indication. FDA also approved the Abbott RealTime IDH1 assay as a companion diagnostic for the selection of R/R MDS patients with an IDH-1 mutation.

Tibsovo was previously approved for certain adults with newly diagnosed acute myeloid leukemia (AML), R/R AML, and locally advanced or metastatic cholangiocarcinoma, FDA says. The Abbott IDH1 assay was previously approved as a companion diagnostic to identify AML patients with an IDH1 mutation for treatment with Tibsovo or Rigel Pharmaceuticals’ Rezlidhia (olutasidenib).

The notice says the Tibsovo labeling includes a Boxed Warning that an adverse reaction known as differentiation syndrome can occur and can be fatal if not treated. FDA granted the drug priority review, breakthrough therapy, and orphan drug designations.

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