The investigational monoclonal antibody sotrovimab (VIR-7831; GSK/Vir Biotechnology) has been granted an FDA Emergency Use Authorization (EUA) for treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease, including hospitalization and death.1 Two other monoclonal antibody regimens are authorized for the same indication: casirivimab (REGN10933) and imdevimab (REGN10987) administered together, and bamlanivimab (LY-CoV555) and etesevimab (LYCoV016) administered together. The FDA revoked its EUA...

The FDA has approved the oral GABA_A receptor modulator zuranolone (Zurzuvae – Sage Therapeutics/Biogen) for treatment of postpartum depression (PPD). Zuranolone is the second drug to be approved for this indication; brexanolone (Zulresso), another GABA_A receptor modulator, was approved for IV treatment of PPD in 2019.

The FDA has approved Exblifep (Allecra), a fixed-dose combination of the cephalosporin cefepime and the beta-lactamase inhibitor enmetazobactam, for IV treatment of adults with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by designated susceptible microorganisms (see Spectrum of Activity). Exblifep is the first product that contains enmetazobactam to be approved in the US.

View Expanded Table: Some Biologic Drugs and JAK Inhibitors for Rheumatoid Arthritis

Toripalimab-tpzi (Loqtorzi – Coherus Biosciences), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with cisplatin and gemcitabine for first-line treatment of recurrent locally advanced or metastatic nasopharyngeal carcinoma and for use as monotherapy for treatment of recurrent unresectable or metastatic nasopharyngeal carcinoma in adults with disease progression on or after platinum-based chemotherapy. It is the first immune checkpoint inhibitor to be approved in the US for treatment of nasopharyngeal carcinoma.

Sacituzumab govitecan-hziy (Trodelvy – Gilead) has been approved for treatment of unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in adults who received prior endocrine therapy and ≥2 additional systemic therapies for metastatic disease. It was previously approved for treatment-refractory metastatic triplenegative breast cancer and for treatment of locally advanced or metastatic urothelial cancer in adults who received platinum-based chemotherapy and a programmed death receptor-1...

Atezolizumab (Tecentriq – Genentech), an immune checkpoint inhibitor, has been approved by the FDA for treatment of unresectable or metastatic alveolar soft part sarcoma (ASPS) in patients ≥2 years old. It was previously approved for treatment of non-small cell lung cancer, small cell lung cancer, hepatocellular cancer, and melanoma (see Table 1). Atezolizumab is the first drug to be approved in the US for treatment of ASPS. ASPS is a rare disorder that affects mostly adolescents and young adults; <1% of soft tissue sarcomas are ASPS.

Zolbetuximab-clzb (Vyloy – Astellas), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, has been approved by the FDA for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients who have CLDN18.2-positive tumors. It is the first monoclonal antibody to be approved in the US that selectively targets CLDN18.2.

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.

In February 2021, the FDA issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibodies bamlanivimab and etesevimab (Lilly) for use together to treat mild to moderate COVID-19 in persons ≥12 years old who weigh ≥40 kg and are at high risk of progression to severe disease or hospitalization. The FDA has now expanded this EUA to allow use of the antibodies together for post-exposure prophylaxis of COVID-19 in such persons if they are not fully vaccinated against COVID-19 or are unlikely to have an adequate immune response to full vaccination and have...