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.

Berdazimer 10.3% gel (Zelsuvmi – Ligand), a first-in-class nitric oxide-releasing agent, has been approved by the FDA for topical treatment of molluscum contagiosum in patients ≥1 year old. It is the second drug to become available in the US for treatment of molluscum contagiosum and the first that can be applied by the patient or caregiver at home; cantharidin 0.7% solution (Ycanth), which is applied by a healthcare professional, was approved earlier for use in patients ≥2 years old.

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.

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.

Avmapki Fakzynja Co-Pack (Verastem), a combination of the kinase inhibitors avutometinib and defactinib, has received accelerated approval from the FDA for treatment of KRAS-mutated recurrent low-grade serous ovarian cancer in women who had previously received systemic therapy. Neither drug is approved for use as monotherapy for any indication. Avmapki Fakzynja is the first treatment to be approved in the US for this indication.

Retifanlimab-dlwr (Zynyz – Incyte), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with carboplatin and paclitaxel for first-line treatment of unresectable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and as monotherapy in patients who had disease progression or intolerance to platinum-based chemotherapy. The drug received accelerated approval for treatment of recurrent locally advanced or metastatic Merkel cell carcinoma in 2023.

The FDA has approved acoltremon 0.003% ophthalmic solution (Tryptyr – Alcon) for treatment of dry eye disease. Acoltremon is the first transient receptor potential melastatin 8 (TRPM8) thermoreceptor agonist to be approved in the US for this indication.

Zongertinib (Hernexeos – Boehringer Ingelheim), an oral kinase inhibitor, has received accelerated approval from the FDA for treatment of adults with unresectable or metastatic nonsquamous non-small cell lung cancer (NSCLC) with human epidermal growth factor 2 (HER2) tyrosine kinase domain activating mutations who had received prior systemic therapy. It is the first oral targeted therapy to be approved in the US for this indication. The intravenous HER2-directed antibody and topoisomerase inhibitor conjugate famtrastuzumab deruxtecan (Enhertu) was approved for the same indication...

The FDA has approved nirsevimab-alip (Beyfortus – AstraZeneca/Sanofi), a long-acting monoclonal antibody, for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children ≤24 months old who are at increased risk for severe RSV disease through their second RSV season. Nirsevimab is the first drug to be approved for protection of all infants during their first RSV season.