The FDA has approved a lower-dose epinephrine auto-injector (Auvi-Q 0.1 mg – Kaléo) for emergency treatment of anaphylaxis in children weighing 7.5-15 kg (16.5-33 lbs). It is the first epinephrine auto-injector to be approved for use in infants and toddlers weighing less than 15 kg. Previously, Auvi-Q and other epinephrine auto-injectors were only available in 0.15- and 0.3-mg strengths for patients weighing 15-30 kg or ≥30 kg, respectively.The recommended dose of epinephrine for intramuscular (IM) or subcutaneous (SC) administration is 0.01 mg/kg. None of the previously available...

The FDA has approved axicabtagene ciloleucel (Yescarta – Kite) for treatment of adults with relapsed or refractory CD19+ large B-cell lymphoma after ≥2 lines of systemic therapy. Yescarta is an individualized cellular product prepared from the patient's own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. It is the second CAR T-cell immunotherapy to become available in the US. Tisagenlecleucel (Kymriah), a CAR T-cell product previously approved for treatment of relapsed or refractory B-cell...

The FDA has approved (Giapreza) (La Jolla), an IV formulation of synthetic angiotensin II, to increase blood pressure in adults with septic or other vasodilatory shock, such as anaphylactic or neurogenic shock. Angiotensin is a naturally occurring peptide hormone in the renin-angiotensin-aldosterone system (RAAS). (Giapreza) is the first synthetic angiotensin II product to become available in the US.

The FDA has approved over-the-counter (OTC) sale of inhaled epinephrine (Primatene Mist – Amphastar), a nonselective alpha and beta agonist, for temporary relief of mild symptoms of intermittent asthma in patients ≥12 years old who have been diagnosed with mild intermittent asthma by a healthcare professional. The original version of Primatene Mist, which was approved by the FDA in 1967, was removed from the market in 2011 because the metered-dose inhaler (MDI) contained ozone-depleting chlorofluorocarbon (CFC) propellants; the new MDI contains hydrofluoroalkane (HFA)...

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Quzyttir (TerSera), an IV formulation of the second-generation H1-antihistamine cetirizine, has been approved by the FDA for treatment of acute urticaria in patients ≥6 months old. Oral formulations of cetirizine (Zyrtec, and others) have been for sale over the counter for years. Quzyttir is the first parenteral formulation of a second-generation H1-antihistamine to become available in the US; parenteral formulations of two first-generation H1-antihistamines, diphenhydramine (Benadryl, and others) and hydroxyzine (Vistaril, and others), have been available for many...

The short-acting beta2-agonist albuterol sulfate has recently become available as a large-volume (20 mL), preservative-free concentrate (albuterol inhalation solution 0.5% – Nephron Pharmaceuticals) that can be used to prepare solutions for administration of continuous nebulized albuterol (CNA). CNA is commonly used (off-label) for acute treatment of severe asthma exacerbations in hospitalized patients, particularly children. Many hospitals have been using a 20-mL multidose bottle of 0.5% albuterol that contains the preservative benzalkonium chloride (BAC) for this purpose. Until...

The FDA has approved the oral kinase inhibitor encorafenib (Braftovi – Pfizer), in combination with the epidermal growth factor receptor (EGFR) inhibitor cetuximab (Erbitux), for treatment of adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation. Encorafenib was approved in 2018 for use with the mitogen-activated kinase (MEK) inhibitor binimetinib (Mektovi) for treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.

The FDA has approved the oral tyrosine kinase inhibitor avapritinib (Ayvakit – Blueprint Medicines) for treatment of unresectable or metastatic gastrointestinal stromal tumors (GISTs) harboring a platelet-derived growth factor receptor alpha (PDGFRA) D842V or other PDGFRA exon 18 mutation. Avapritinib is the first drug to be approved for this indication in the US.

Casimersen (Amondys 45 – Sarepta), an IV antisense oligonucleotide, has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients who have mutations of the dystrophin gene that are amenable to exon 45 skipping (DMD-45), which occur in ~8% of DMD cases. Casimersen is the first drug to be approved for this indication and the fifth to be approved for treatment of DMD; the IV antisense oligonucleotides eteplirsen (Exondys 51), golodirsen (Vyondys 53), and viltolarsen (Viltepso) and the oral corticosteroid deflazacort (Emflaza) were...