The oral cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio – Lilly), which was approved by the FDA in 2017 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 in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of patients with HR-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%.

The FDA has approved datopotamab deruxtecan (Datroway – Daiichi Sankyo/AstraZeneca), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

On December 22, 2021, the FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug nirmatrelvir copackaged with the HIV-1 protease inhibitor ritonavir (Paxlovid – Pfizer) for oral treatment of mild to moderate COVID-19 in outpatients ≥12 years old who weigh at least 40 kg and are at high risk of progressing to severe disease, including hospitalization or death. Paxlovid was the first oral antiviral drug to be authorized in the US for treatment of COVID-19; Merck's oral antiviral drug molnupiravir was granted an EUA for treatment of COVID-19 on...

The FDA has approved the oral tyrosine kinase inhibitor repotrectinib (Augtyro – BMS) for treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. Repotrectinib is the third oral tyrosine kinase inhibitor to be approved for this indication in the US; crizotinib (Xalkori) and entrectinib (Rozlytrek) were approved earlier.

Primary hypothyroidism is usually the result of Hashimoto's (autoimmune) thyroiditis, thyroidectomy, or radioactive iodine therapy. Treatment of hypothyroidism with replacement doses of thyroid hormone is usually lifelong. Levothyroxine (LT4; synthetic thyroxine; Synthroid, and others) is the drug of choice.1

The FDA has approved sacituzumab govitecan-hziy (Trodelvy – Immunomedics), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with metastatic triple-negative breast cancer who have received ≥2 prior therapies for metastatic disease. It is the first Trop-2-directed antibody-drug conjugate to become available in the US.

The FDA has approved suzetrigine (Journavx – Vertex), a selective sodium channel blocker, for oral treatment of moderate to severe acute pain in adults. Suzetrigine is the first sodium channel blocker to be approved in the US for this indication and the first oral nonopioid drug to be approved for treatment of pain in over 25 years.

The FDA has approved a 0.3% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of plaque psoriasis in patients ≥12 years old. Roflumilast is the first topical PDE4 inhibitor to be approved by the FDA for this indication; crisaborole (Eucrisa), another topical PDE4 inhibitor, is approved for treatment of atopic dermatitis. Oral roflumilast (Daliresp) is approved for treatment of chronic obstructive pulmonary disease.

The FDA has approved a 0.3% foam formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of seborrheic dermatitis in patients ≥9 years old. Roflumilast is the first PDE4 inhibitor to be approved in the US for this indication. It is also available in a 0.3% cream formulation (Zoryve) for treatment of plaque psoriasis and in an oral formulation (Daliresp, and generics) for treatment of chronic obstructive pulmonary disease. A 0.15% cream formulation for treatment of atopic dermatitis in patients ≥6 years old will be reviewed...

The FDA has approved oteseconazole (Vivjoa – Mycovia), a new oral azole antifungal, to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC. Oteseconazole is the first drug to be approved in the US specifically for treatment of RVVC.