Drugs

AbbVie’s NDA for Dendritic Cell Neoplasms Approved

FDA has approved an AbbVie NDA for Decnupaz (pivekimab sunirine-pvzy), a CD123-directed antibody and alkylating agent conjugate for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

The agency says the approval was based in data from the CADENZA (NCT03386513) study, a multicenter, open-label, single-arm clinical trial that included adult patients with treatment-naïve BPDCN (N=33) or relapsed or refractory BPDCN (N=51), without evidence of active central nervous system disease. Efficacy was based on the rate of complete remission or clinical complete remission (CR/CRc).

“In patients with treatment-naïve BPDCN (N = 33), 23 patients (69.7%; 95% CI: 51.3, 84.4) achieved a CR/CRc with a median follow-up of 21.5 months,” it says. “The median duration of CR/CRc was 9.7 months (95% CI: 2.9, not estimable). In patients with relapsed or refractory BPDCN (N = 51), 8 patients (15.7%; 95% CI: 7.0, 28.6) achieved a CR/CRc with a median follow-up of 24.1 months. The median duration of CR/CRc was 9.2 months (Range: 2.7, 27.6+).”

The prescribing information includes a Boxed Warning for hepatotoxicity, including hepatic veno-occlusive disease, and warnings and precautions for infusion-related reactions, edema, sulfite allergic reactions, and embryo-fetal toxicity, according to the agency.

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