Since our initial review of the oral lipid-lowering adenosine triphosphate-citrate lyase (ACL) inhibitor bempedoic acid (Nexletol – Esperion) in 2020, cardiovascular outcomes data in statin-intolerant patients have become available.

The FDA has granted regular approval to dostarlimabgxly (Jemperli – GSK), an immune checkpoint inhibitor, for treatment of adults with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation. Dostarlimab received accelerated approval in 2021 for treatment of adults with dMMR recurrent or advanced endometrial cancer or nonendometrial solid tumors that progressed on or following prior treatment and who have no...

The investigational anti-complement component 5a (C5a) antibody vilobelimab (Gohibic – InflaRx) has been granted an FDA Emergency Use Authorization (EUA) for IV treatment of hospitalized adults with COVID-19 beginning within 48 hours after invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) is started. Vilobelimab is the first anti-C5a antibody to become available in the US.

Results from a double-blind trial suggest that off-label use of the oral antihyperglycemic drug metformin in patients with COVID-19 may decrease the risk of post-acute sequelae of SARS-CoV-2 infection ("long COVID").

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy) has been approved by the FDA to reduce the risk of major adverse cardiovascular events (MACE) in adults with established cardiovascular disease (CVD) and either obesity or overweight. Semaglutide is the first drug to be approved for cardiovascular risk reduction in this population. It is also approved in a lower-dose injectable formulation as Ozempic and in an oral formulation as Rybelsus (see Table 1).

Tisotumab vedotin-tftv (Tivdak – Seagen/Genmab), a tissue factor-directed antibody and microtubule inhibitor conjugate, has received full approval from the FDA for treatment of recurrent or metastatic cervical cancer that progressed on or after chemotherapy. It is the first antibody-drug conjugate to be approved for treatment of cervical cancer. The drug received accelerated approval from the FDA in 2021 for the same indication.

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali – Novartis), which was approved by the FDA in 2017 for use with an aromatase inhibitor or fulvestrant 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 with an aromatase inhibitor for adjuvant treatment of HR-positive, HER2-negative stage II or III early breast cancer at high risk of recurrence. Kisqali can be used in patients with node-positive or node-negative disease. The CDK 4/6...

Revumenib (Revuforj – Syndax), an oral menin inhibitor, has been approved by the FDA for treatment of relapsed or refractory acute leukemia in patients ≥1 year old with a lysine methyltransferase 2A gene (KMT2A) translocation. It is the first menin inhibitor to be approved in the US.

The FDA has approved Azmiro (Azurity), the first injectable formulation of testosterone cypionate to become available in single-dose vials and prefilled syringes for treatment of males with conditions associated with a deficiency or absence of endogenous testosterone. Injectable testosterone cypionate has been available in multidose vials (Depo-Testosterone, and generics) for many years. Testosterone enanthate (Xyosted) is available in prefilled autoinjectors for use in adult men. No testosterone products are approved for treatment of low testosterone levels due solely to aging. All...

Mirdametinib (Gomekli – SpringWorks Therapeutics), an oral kinase inhibitor, has been approved by the FDA for treatment of neurofibromatosis type 1 (NF1) in patients ≥2 years old who have symptomatic plexiform neurofibromas not amenable to complete resection. Mirdametinib is the second drug to be approved for this indication in the US and the first to be approved for use in adults. The oral kinase inhibitor selumetinib (Koselugo) was approved in 2020 for use in patients 2-17 years old.