FDA Policy/General

Product Approval Summaries

DEVICES

FDA has cleared an Adaptiiv 510(k) for its 3D Bolus Software for use in creating customized personal medical devices using 3D printing, primarily for use in treating cancer. The software allows practitioners 3D printing of patient-specific uniform thickness bolus, modulated bolus for MERT (modulated electron radiation therapy), High-Dose Rate surface brachytherapy and other potential ancillary devices.

FDA has cleared a Vallum Corp. 510(k) to market a polyetheretherketone (PEEK) spinal interbody fusion device with a PEEKplus nanotextured surface created by the company’s proprietary Accelerated Neutral Atom Beam technology. “Nano-scale concavities of 20-50 nanometers are created by the impact of argon atoms across the entire existing microsurface of the PEEK to create the nanotexture of PEEKplus,” the company says. “Importantly, nanotexturing below 100 nanometers has been shown to be beneficial to osteoblast functions that are necessary to grow bone and promote fusion.”

DRUGS

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.

FDA has approved a Pfizer BLA for Nivestym (filgrastim-aafi), a biosimilar product referencing Amgen’s Neupogen, indicated for treating neutropenia. Filgrastim is a short acting granulocyte-colony stimulating factor that increases the body’s production of white blood cells. The BLA submission is supported by similarity data from analytical, pre-clinical and clinical development studies, comparing the biosimilar candidate to Neupogen, according to Pfizer.

FDA has approved Terumo BCT’s sodium citrate 4% solution USP, indicated for anticoagulating whole blood during automated apheresis procedures. The product has been on the agency’s shortage list for over a year and is manufactured at Terumo BCT's facility in Larne, UK, which supplies parts of Europe, Asia and Australia.

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