The FDA has approved Semglee (Mylan), an insulin glargine product similar to Lantus, for treatment of type 1 diabetes in children and adults and type 2 diabetes in adults. Semglee is the second "follow-on" insulin glargine product to become available in the US; Basaglar, which is also similar to Lantus, was the first. Lantus is a recombinant analog of human insulin that forms microprecipitates in subcutaneous tissue, prolonging its duration of action to a mean of about 24 hours with no pronounced peak effect.

The FDA has approved setmelanotide (Imcivree – Rhythm), a subcutaneously injected melanocortin 4 (MC4) receptor agonist, for chronic weight management in patients ≥6 years old with obesity due to pro-opiomelanocortin (POMC) deficiency, proprotein subtilisin/kexin type 1 (PCSK1) deficiency, or leptin receptor (LEPR) deficiency.

Rilonacept (Arcalyst – Kiniksa), an interleukin-1 (IL-1) antagonist that has been available for years for treatment of cryopyrin-associated periodic syndromes, has now been approved by the FDA for treatment of recurrent pericarditis and prevention of further recurrences in patients ≥12 years old. It is the first drug to be approved in the US for this indication. Anakinra (Kineret), an IL-1 receptor antagonist FDA-approved for treatment of rheumatoid arthritis, has been used off-label for years for treatment of recurrent pericarditis.

Xywav (Jazz), an oral solution that contains calcium, magnesium, potassium, and sodium oxybates, has been approved by the FDA for treatment of idiopathic hypersomnia in adults. It is the first drug to be approved in the US for this indication. Xywav was approved in 2020 for treatment of excessive daytime sleepiness or cataplexy in patients ≥7 years old with narcolepsy. It contains about 92% less sodium than sodium oxybate oral solution (Xyrem), which has been available in the US for years for use in patients ≥7 years old with narcolepsy.

The FDA has approved Acuvue Theravision with Ketotifen (Johnson & Johnson Vision Care), a daily-wear, disposable, vision-correcting soft contact lens that releases the H₁-antihistamine ketotifen, for prevention of ocular itch due to allergic conjunctivitis in contact lens users. This is the first approval for a drug-eluting contact lens. Ketotifen eye drops (Alaway, Zaditor, and others) are available over the counter.

The oral kinase inhibitor alpelisib (Vijoice – Novartis) has been approved by the FDA for treatment of patients ≥2 years old with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic treatment. Alpelisib is the first drug to be approved in the US for this indication. It was also approved in 2019 as Piqray for use in combination with fulvestrant for treatment of certain types of breast cancer.

The oral tyrosine kinase inhibitor neratinib (Nerlynx – Puma Biotechnology) has been approved by the FDA for use in combination with capecitabine (Xeloda, and generics) for treatment of advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults who received ≥2 prior anti-HER2-based regimens for metastatic disease. It was previously approved for use as monotherapy for extended adjuvant treatment of adults with early-stage, HER2-positive breast cancer following adjuvant trastuzumab (Herceptin)-based therapy. HER2 is overexpressed in...

The oral kinase inhibitor tucatinib (Tukysa – Seagen) has received accelerated approval from the FDA for use in combination with trastuzumab (Herceptin) for treatment of adults with RAS wild-type human epidermal growth factor receptor 2 (HER2)-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimens. Tucatinib was approved in 2020 for use in combination with trastuzumab and capecitabine (Xeloda, and generics) for treatment of adults with advanced unresectable or...

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.