The FDA has approved margetuximab-cmkb (Margenza – MacroGenics), a HER2/neu receptor antagonist, for use in combination with chemotherapy for treatment of metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults who received ≥2 prior anti-HER2 regimens, at least one of which was for metastatic disease.

The FDA has approved anifrolumab-fnia (Saphnelo – AstraZeneca), a type I interferon receptor antagonist, for IV treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard treatment. Anifrolumab has not been studied in patients with severe active lupus nephritis or severe active CNS lupus. It is the first type I interferon receptor antagonist to become available in the US.

AD-Detect (Quest), a blood test to evaluate Alzheimer's disease risk, is being marketed directly to consumers. It has not been cleared or approved by the FDA (laboratory-developed tests like this one currently do not need FDA authorization to be marketed).

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The FDA has approved the oral Janus kinase (JAK) inhibitor deuruxolitinib (Leqselvi – Sun) for treatment of severe alopecia areata in adults. Two other oral JAK inhibitors are approved for treatment of severe alopecia areata: baricitinib (Olumiant) is approved for use in adults, and ritlecitinib (Litfulo) is approved for use in patients ≥12 years old.

The FDA has granted regular approval to the oral kinase inhibitor capmatinib (Tabrecta – Novartis) for treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping. MET exon 14 skipping mutations occur in 3-4% of NSCLC cases. The drug received accelerated approval for the same indication in 2020 based on initial overall response rates and duration of response.

The FDA has issued an Emergency Use Authorization (EUA) for the long-acting investigational IV monoclonal antibody pemivibart (Pemgarda – Invivyd) for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old (weight ≥40 kg) who have moderate to severe immune compromise and are unlikely to respond adequately to COVID-19 vaccination (see Table 1). Pemgarda is the only drug that is currently authorized in the US for pre-exposure prophylaxis of COVID-19. Tixagevimab/cilgavimab (Evusheld) was previously available under an EUA for this indication, but it lacks activity against...

Zanidatamab-hrii (Ziihera – Jazz), a bispecific HER2-directed antibody, has received accelerated approval from the FDA for treatment of unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer in patients who received prior therapy. Biliary tract cancer includes gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma. Zanidatamab is the first dual HER2-targeted therapy to be approved in the US for this indication. Accelerated approval was based on the overall response rate and duration of response.