The FDA has approved cemiplimab-rwlc (Libtayo – Regeneron), an immune checkpoint inhibitor, for use in combination with platinum-based chemotherapy for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS1 aberrations and who are not candidates for surgical resection or chemoradiation. The drug was previously approved for first-line treatment of NSCLC in patients whose tumors have high PD-L1 expression and no genomic tumor aberrations....

The FDA has approved vorasidenib (Voranigo – Servier), an oral isocitrate dehydrogenase (IDH) inhibitor, for treatment of grade 2 astrocytoma or oligodendroglioma in patients ≥12 years old with an IDH1 or IDH2 mutation. It is the first systemic treatment to be approved in the US for this indication.

The Advisory Committee on Immunization Practices (ACIP) has issued new recommendations for meningococcal vaccination. Booster vaccination against Neisseria meningitidis serogroup B (MenB) is now recommended in persons at increased risk for meningococcal disease (see Table 1). MenB booster doses were not recommended previously for any population.

The FDA has approved Soaanz (Sarfez), a new formulation of the loop diuretic torsemide, for treatment of edema associated with heart failure or renal disease in adults. Torsemide has been available generically for years for treatment of hypertension and treatment of edema due to heart failure, renal disease, or hepatic disease. According to the manufacturer, Soaanz tablets are formulated to provide a gradual and sustained diuresis, lowering the risk of excessive urination and hypokalemia.

The FDA has required changes in the labels of all testosterone products to reflect new data on their cardiovascular effects. The updated labels will no longer include a boxed warning about an increased risk of adverse cardiovascular outcomes, but will contain a new warning about an increase in blood pressure.

The FDA recently expanded the eligibility criteria (see Table 1) for treatment with the surgically implanted hypoglossal nerve stimulation system (Inspire Upper Airway Stimulation – Inspire Medical Systems). The device has been advertised lately on radio and television.

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio – Lilly), which was approved by the FDA in 2017 for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, has now been approved for use in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of patients with HR-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%.

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 Advisory Committee on Immunization Practices (ACIP) recommends use of certain vaccines in adults residing in the US. Routine childhood immunization has reduced the overall incidence of some of these vaccine-preventable diseases, but many adults remain susceptible. Recommendations for vaccination against COVID-19, seasonal influenza, and monkeypox and vaccination of travelers have been reviewed separately.

View the Treatment of COVID-19 in High-Risk Outpatients Chart