The FDA has approved Xacduro (Innoviva), a combination of the beta-lactam antibacterial sulbactam and the beta-lactamase inhibitor durlobactam, for IV treatment of adults with hospital-acquired or ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (ABC).

The FDA has approved cantharidin 0.7% solution (Ycanth – Verrica) for topical treatment of molluscum contagiosum in patients ≥2 years old. Ycanth was the first drug to be approved in the US for this indication. A 10.3% gel formulation of berdazimer (Zelsuvmi), a nitric oxide-releasing agent, has also been approved by the FDA for treatment of molluscum contagiosum (in patients ≥1 year old); it will be reviewed in a future issue.

Tovorafenib (Ojemda – Day One), a type II RAF kinase inhibitor, has received accelerated approval from the FDA for treatment of patients ≥6 months old with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement or a BRAF V600 mutation. Tovorafenib is the first systemic treatment to be approved in the US for pediatric low-grade gliomas with BRAF fusions. Accelerated approval of tovorafenib was based on response rates and duration of response.

The FDA has approved a 0.25% ophthalmic solution of the ectoparasiticide lotilaner (Xdemvy – Tarsus) for treatment of Demodex blepharitis. Lotilaner is the first drug to be approved in the US for this indication.

Betibeglogene autotemcel (Zynteglo — Bluebird Bio), an autologous lentiviral vector cell-based gene therapy, has been approved by the FDA for one-time treatment of transfusion-dependent beta thalassemia in children and adults. Exagamglogene autotemcel (Casgevy), a cell-based gene therapy that uses CRISPR/Cas9 gene-editing technology, was approved earlier this year for the same indication in patients ≥12 years old.

The FDA has approved imetelstat (Rytelo – Geron), a first-in-class telomerase inhibitor, for treatment of low- to intermediate-1 risk myelodysplastic syndromes (MDS) in adults with transfusion-dependent anemia requiring 4 or more red blood cell (RBC) units over 8 weeks who have not responded to, are no longer responding to, or are ineligible for erythropoiesis-stimulating agents (ESAs).

The FDA has approved datopotamab deruxtecan (Datroway – Daiichi Sankyo/AstraZeneca), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

The FDA has approved acoramidis (Attruby – BridgeBio), an oral transthyretin stabilizer, to reduce cardiovascular-related hospitalization and cardiovascular death in adults with wild-type or variant (hereditary) transthyretin amyloid cardiomyopathy (ATTR-CM). Acoramidis is the second transthyretin stabilizer to be approved in the US for this indication; tafamidis (Vyndaqel, Vyndamax) was approved in 2019.

The FDA has approved Akynzeo (Helsinn/Eisai), an oral fixed-dose combination of the substance P/neurokinin 1 (NK1) receptor antagonist netupitant and the serotonin-3 (5-HT3) receptor antagonist palonosetron, for prevention of acute and delayed nausea and vomiting associated with cancer chemotherapy in adults. Akynzeo is the first product to combine drugs from these two classes. Palonosetron (Aloxi) is also available as a single agent for prevention of chemotherapy-induced and postoperative nausea and vomiting. Netupitant is the second substance P/NK1 receptor antagonist to be...

The FDA has approved Zepatier (Merck), a fixed-dose combination of two direct-acting antiviral agents — elbasvir, an NS5A inhibitor, and grazoprevir, an NS3/4A protease inhibitor — for oral treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection.