The FDA has licensed mNEXSPIKE (Moderna), an mRNA vaccine, for prevention of COVID-19 in adults ≥65 years old and in persons 12-64 years old who have a condition that puts them at high risk for severe outcomes from COVID-19. Spikevax, the original Moderna mRNA COVID-19 vaccine, remains in production2; it is licensed for use in persons ≥12 years old and is available under an Emergency Use Authorization (EUA) for children 6 months to 11 years old.

Telisotuzumab vedotin-tllv (Emrelis – Abbvie), a c-Met-directed antibody and microtubule inhibitor conjugate, has received accelerated approval from the FDA for treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) in adults with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining] who received prior systemic therapy. Accelerated approval was based on the overall response rate and duration of response.

Dordaviprone (Modeyso – Jazz), an oral protease activator, has received accelerated approval from the FDA for treatment of diffuse midline gliomas harboring a H3 K27M mutation in patients ≥ year old who had disease progression following prior treatment. It is the first drug to be approved in the US for this indication.

The FDA has approved pitolisant (Wakix – Harmony), a histamine-3 (H₃)-receptor antagonist/inverse agonist, for treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. It is the first H₃-receptor antagonist/inverse agonist to become available in the US and the first non-controlled substance to receive FDA approval for these indications. Pitolisant has been available in Europe since 2016.

The FDA has approved fenfluramine oral solution (Fintepla – Zogenix) for treatment of seizures in patients ≥2 years old with Dravet syndrome. It is the third drug to be approved for this indication. Stiripentol (Diacomit) and cannabidiol (Epidiolex), a purified product derived from marijuana, were approved earlier.

The FDA has approved the injectable interleukin (IL)-17A/17F antagonist bimekizumab-bkzx (Bimzelx – UCB) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic treatment or phototherapy. Bimekizumab is the first IL-17A/17F antagonist to be approved in the US. It was approved in the European Union for the same indication in 2021.

Ceftobiprole medocaril sodium (Zevtera – Innoviva Specialty Therapeutics), a new IV cephalosporin antibacterial drug, has been approved by the FDA for treatment of Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSIs), and community-acquired bacterial pneumonia (CABP) (see Table 1). It is the second cephalosporin with activity against methicillin-resistant S. aureus (MRSA) to be approved in the US; ceftaroline (Teflaro), which was approved for treatment of ABSSSIs and CABP in 2010, was the...

A new CDC guideline for prescribing opioids for pain recently became available. Nonopioid drugs for pain were reviewed in a previous issue.

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.