The opioid agonist tramadol is now available in an oral solution (Qdolo – Athena Bioscience) for management of pain severe enough to require an opioid and for which alternative treatment options are inadequate. Tramadol has been available for years in immediate-release tablets and capsules, extended-release capsules (Ultram, and others), and in a fixed-dose combination tablet with acetaminophen (Ultracet, and generics).

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.

The FDA has approved an over-the-counter (OTC) liquid-filled capsule formulation of aspirin (Vazalore – PLx Pharma). The manufacturer has been heavily promoting Vazalore with claims of fast, predictable absorption and antiplatelet activity and improved gastrointestinal safety compared to existing OTC aspirin formulations.

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.

The FDA has approved cemiplimab-rwlc (Libtayo – Regeneron), an immune checkpoint inhibitor, for use in combination with platinum-based chemotherapy for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS1 aberrations and who are not candidates for surgical resection or chemoradiation. The drug was previously approved for first-line treatment of NSCLC in patients whose tumors have high PD-L1 expression and no genomic tumor aberrations....