Sunvozertinib (Zegfrovy – Dizal), an oral kinase inhibitor, has received accelerated approval from the FDA for treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations who had disease progression on or after platinum-based chemotherapy.

The FDA has approved a 12.5-mg tablet formulation of the thiazide-like diuretic chlorthalidone (HemiClor – Ingenus) for treatment of hypertension. Chlorthalidone has been available for years in 15-, 25-, and 50-mg tablets (Thalitone, and generics) and in fixed-dose combinations with azilsartan medoxomil (Edarbyclor) and atenolol (Tenoretic, and generics).

The FDA has approved the complement C5 inhibitor avacincaptad pegol (Izervay – Iveric) for intravitreal treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Avacincaptad pegol is the second complement inhibitor to be approved in the US for this indication; pegcetacoplan (Syfovre), a complement C3 and C3b inhibitor, was approved earlier.

The FDA has warned that the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) are unlikely to neutralize the XBB.1.5 Omicron variant of SARS-CoV-2. Evusheld is available under an Emergency Use Authorization (EUA) for IM pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of a severe adverse reaction that prevents their vaccination against COVID-19 or moderate or severe immune compromise.

The FDA has approved a fixed-dose combination of the amide local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam as an extended-release (ER) solution (Zynrelef – Heron) for single-dose, intraoperative, soft-tissue or periarticular instillation to provide postsurgical analgesia for up to 72 hours in adults undergoing foot and ankle, small-to-medium open abdominal, or lower extremity total joint arthroplasty surgical procedures.

The FDA has approved a 2% cream formulation of delgocitinib (Anzupgo – Leo), a Janus kinase (JAK) inhibitor, for treatment of moderate to severe chronic hand eczema (dermatitis) in adults who had an inadequate response to or are unable to use topical corticosteroids. Delgocitinib is the first drug to be approved in the US for this indication. Ruxolitinib, another JAK inhibitor, is available in a 1.5% cream formulation (Opzelura) for treatment of mild to moderate atopic dermatitis in patients ≥2 years old.

Our recent article on Drugs for Hypertension (Med Lett Drugs Ther 2024; 66:81) described both the Paradise and Symplicity Spyral renal denervation devices as ultrasound devices. That is true for the Paradise device, but Symplicity Spyral uses radiofrequency ablation.

Insulin glargine-aglr (Rezvoglar – Lilly), which was approved by the FDA as a biosimilar to the reference product Lantus in 2021 and received interchangeability status with Lantus in 2022, will become available in the US on April 1, 2023. It is the second biosimilar insulin product to be designated as interchangeable with Lantus; Semglee was the first. Rezvoglar did not receive interchangeability status with Lantus at the time of its initial approval because the manufacturer of Semglee had exclusivity for 12 months.

The FDA has approved setmelanotide (Imcivree – Rhythm), a subcutaneously injected melanocortin 4 (MC4) receptor agonist, for chronic weight management in patients ≥6 years old with obesity due to pro-opiomelanocortin (POMC) deficiency, proprotein subtilisin/kexin type 1 (PCSK1) deficiency, or leptin receptor (LEPR) deficiency.

The oral tyrosine kinase inhibitor neratinib (Nerlynx – Puma Biotechnology) has been approved by the FDA for use in combination with capecitabine (Xeloda, and generics) for treatment of advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults who received ≥2 prior anti-HER2-based regimens for metastatic disease. It was previously approved for use as monotherapy for extended adjuvant treatment of adults with early-stage, HER2-positive breast cancer following adjuvant trastuzumab (Herceptin)-based therapy. HER2 is overexpressed in...