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 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 oral nonergot dopamine agonist pramipexole (Mirapex ER, and generics), which is FDA-approved for treatment of Parkinson's disease and restless legs syndrome, has been used off-label in patients with treatment-resistant depression (TRD). A double-blind, placebo-controlled trial of pramipexole augmentation in patients with unipolar TRD was recently published.

Saxagliptin (Onglyza - Bristol-Myers Squibb), the second oral dipeptidyl peptidase-4 (DPP-4) inhibitor to be marketed in the US, has been approved by the FDA for treatment of adults with type 2 diabetes.

The oral antimalarial tafenoquine succinate, a long-acting analog of primaquine, has been approved by the FDA in 2 different strengths. Arakoda (100-mg tablets; Sixty Degrees) is indicated for the prophylaxis of malaria in adults. Krintafel (150-mg tablets; GSK) is indicated for the prevention of relapse (radical cure) of Plasmodium vivax malaria in patients ≥16 years old undergoing treatment for acute P. vivax infection.

The FDA has approved lemborexant (Dayvigo – Eisai), an orexin receptor antagonist, for treatment of sleep-onset and/or sleep-maintenance insomnia in adults. It is the second orexin receptor antagonist to be approved for this indication; suvorexant (Belsomra) was the first.

View the Comparison Table: Some Lipid-Lowering Drugs

Astemizole (Hismanal - Janssen), a new antihistamine, was recently marketed in the USA for treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. Like terfenadine (Seldane - Medical Letter, 27:65, 1985), astemizole is claimed to be no more sedating than placebo, but the new drug offers the advantage of a once-daily dosage schedule.

Carteolol (Cartrol - Abbott) and penbutolol (Levatol - Reed & Carnrick), two oral beta-adrenergic blocking drugs, were recently approved by the US Food and Drug Administration for once-daily treatment of systemic hypertension. Both drugs are non-selective beta-blockers with mild partial agonist activity. Beta-blockers currently available in the USA for treatment of hypertension are listed in the table on the next page.

Recent articles in the press have suggested that mifepristone (RU 486 - Roussel Uclaf) can effectively and safely induce an abortion. The drug is currently available only in France and China, but the manufacturer has also applied for a license in the United Kingdom. Mifepristone has been used on an investigational basis in the USA as an abortifacient and for treatment of Cushing's disease and breast cancer, but no manufacturer has applied to the US Food and Drug Administration for approval to market the drug in this country.