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....

Enfortumab vedotin-ejfv (Padcev – Astellas), a nectin-4-directed antibody and microtubule inhibitor conjugate, has received accelerated approval from the FDA for use with the immune checkpoint inhibitor pembrolizumab (Keytruda) for treatment of locally advanced or metastatic urothelial cancer in adults who are ineligible for cisplatin-containing chemotherapy. Accelerated approval was based on tumor response rates and the durability of response.

Sotorasib (Lumakras — Amgen), an oral KRAS inhibitor, has received accelerated approval by the FDA for treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who received at least one prior systemic therapy. Accelerated approval was based on the overall response rate and duration of response. KRAS mutations are found in 25-30% of non-squamous-cell NSCLC cases and the G12C mutation is the most common KRAS mutation. Sotorasib is the first KRAS inhibitor to be approved in the US.

Axatilimab-csfr (Niktimvo – Incyte), a colony stimulating factor-1 receptor-blocking antibody, has been approved by the FDA for intravenous treatment of chronic graft-versus-host disease (cGVHD) after failure of at least 2 lines of systemic therapy in patients weighing ≥40 kg. Corticosteroids are generally the first-line treatment for cGVHD. The oral kinase inhibitors ibrutinib (Imbruvica), ruxolitinib (Jakafi), and belumosudil (Rezurock) are also approved for treatment of cGVHD. Extracorporeal photopheresis has been used off-label.

The FDA has approved vorasidenib (Voranigo – Servier), an oral isocitrate dehydrogenase (IDH) inhibitor, for treatment of grade 2 astrocytoma or oligodendroglioma in patients ≥12 years old with an IDH1 or IDH2 mutation. It is the first systemic treatment to be approved in the US for this indication.

Isatuximab-irfc (Sarclisa – Sanofi), a CD38-directed cytolytic antibody, has been approved by the FDA for treatment of newly diagnosed multiple myeloma in adults who are not eligible for autologous stem cell transplantation (ASCT). The drug was approved earlier for treatment of relapsed or treatment-refractory multiple myeloma.

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.

The FDA has approved ensartinib (Ensacove – Xcovery), an oral kinase inhibitor, for treatment of anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who have not previously received an ALK inhibitor (e.g, crizotinib [Xalkori], certinib [Zykadia], alectinib [Alecensa], brigatinib [Alunbrig], lorlatinib [Lorbrena]). All previously approved ALK inhibitors are also approved for first-line use.