Teclistamab-cqyv (Tecvayli – Janssen), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, has been granted accelerated approval by the FDA for treatment of relapsed or refractory multiple myeloma in adults who received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Accelerated approval was based on response rate. Teclistamab is the first bispecific BCMA-directed CD3 T-cell engager to be approved in the US.

Dupilumab (Dupixent – Sanofi/Regeneron), a subcutaneously injected interleukin (IL)-4 receptor alpha antagonist that is FDA-approved for several indications, including treatment of chronic rhinosinusitis with nasal polyps, has now been approved for treatment of allergic fungal rhinosinusitis (AFRS) in patients ≥6 years old who previously had sinonasal surgery. It is the first drug to be approved in the US for this indication.

Claims for the superiority of various calcium supplements are now appearing on television and in the print media. A high calcium intake combined with vitamin D can increase bone density and reduce the incidence of fractures in older women and probably also in men.

Ciclesonide (Omnaris - Sepracor/Nycomed), a once daily corticosteroid nasal spray, is now available for treatment of seasonal allergic rhinitis (SAR) in adults and children ≥6 years old and for perennial allergic rhinitis (PAR) in those ≥12 years old. An orally inhaled formulation of ciclesonide (Alvesco) was recently approved by the FDA for maintenance treatment of asthma, and will be reviewed in a future issue of The Medical Letter

Lonapegsomatropin-tcgd (Skytrofa – Ascendis), a long-acting prodrug of recombinant human growth hormone (rhGH), has been approved by the FDA for once-weekly subcutaneous (SC) treatment of growth failure due to inadequate secretion of endogenous growth hormone in children ≥1 year old who weigh ≥11.5 kg. It is the first once-weekly rhGH product to be approved in the US; other available rhGH formulations are administered more frequently.

The FDA has approved the antiviral drug remdesivir (Veklury – Gilead) for IV treatment of COVID-19 in hospitalized patients who are ≥12 years old and weigh ≥40 kg. Hospitalized children who are <12 years old or weigh <40 kg can receive remdesivir through an Emergency Use Authorization (EUA). Remdesivir is the first drug to be approved in the US for treatment of COVID-19.

The FDA has approved Clenpiq (Ferring), a low-volume oral solution that contains sodium picosulfate, magnesium oxide, and anhydrous citric acid, for colon cleansing prior to colonoscopy in adults. The ready-to-drink solution contains the same ingredients as Prepopik, which is supplied as a powder for reconstitution.

The immune checkpoint inhibitor dostarlimab-gxly (Jemperli – GSK) has been approved by the FDA for use in combination with carboplatin and paclitaxel for treatment of adults with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. Dostarlimab was recently granted regular approval for treatment of adults with dMMR recurrent or advanced endometrial cancer that progressed on or following a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.

The recent increase in deaths from heroin overdose in the US has led to renewed interest in the opioid antagonist naloxone, particularly in making it available as an intranasal spray to paramedics and possibly to relatives and close friends of heroin users. Intravenous (IV) administration is preferred, but peripheral venous access may be difficult to obtain in IV drug abusers, and exposure to their blood may be hazardous.

Fenoldopam mesylte (Corlopam - Neurex), a peripheral dopamine-1 (DA₁) agonist, has been approved by the FDA for parenteral use in lowering blood pressure. The manufacturer claims that, unlike other parenteral antihypertensive agents, fenoldopam not only lowers blood pressure but also maintains or improves renal function.