The FDA has approved avelumab (Bavencio – EMD Serono) and durvalumab (Imfinzi – AstraZeneca), two new immune check point inhibitors, and pembrolizumab (Keytruda – Merck), a checkpoint inhibitor that has been available in the US since 2014, for treatment of locally advanced or metastatic bladder cancer. Nivolumab (Opdivo) and atezolizumab (Tecentriq) were approved earlier for this indication.

The prognosis in breast cancer is generally poor for women with unresectable, locally advanced disease (inflammatory cancer or more than 10 positive lymph nodes) and for those with metastases. Autologous bone marrow transplantation - removing bone marrow from multiple sites under general anesthesia, giving high-dose chemotherapy with or without total body radiation, and reinfusing the bone marrow intravenously - is being tried in some of these patients.

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....

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 the immune checkpoint inhibitor atezolizumab (Tecentriq – Genentech) for treatment of locally advanced or metastatic urothelial carcinoma and metastatic non-small cell lung cancer (NSCLC) that have progressed during or following platinum-based chemotherapy. Atezolizumab is the first programmed death-ligand 1 (PD-L1) blocking antibody to become available in the US. Two other immune checkpoint inhibitors, the programmed death receptor-1 (PD-1) inhibitors nivolumab (Opdivo) and pembrolizumab (Keytruda), are also approved for treatment of metastatic NSCLC, and...

Trastuzumab (Herceptin - Genentech), a recombinant 'humanized' monoclonal antibody (rhuMAb) that binds to a protein encoded by the oncogene HER2, and capecitabine (ka pe site' a been; Xeloda - Roche), an oral pro-drug for 5-fluorouracil, have been approved by the FDA for treatment of metastatic breast cancer.

Gemtuzumab ozogamicin, a monoclonal antibody bound to a cytotoxic antibiotic, has been approved by the FDA for treatment of patients with CD33-positive acute myeloid leukemia (AML) in first relapse who are more than 60 years old and may not be able to tolerate cytotoxic chemotherapy

Toripalimab-tpzi (Loqtorzi – Coherus Biosciences), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with cisplatin and gemcitabine for first-line treatment of recurrent locally advanced or metastatic nasopharyngeal carcinoma and for use as monotherapy for treatment of recurrent unresectable or metastatic nasopharyngeal carcinoma in adults with disease progression on or after platinum-based chemotherapy. It is the first immune checkpoint inhibitor to be approved in the US for treatment of nasopharyngeal carcinoma.

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.

Ramucirumab (Cyramza – Lilly), a monoclonal antibody that inhibits vascular endothelial growth factor receptor 2 (VEGFR2), has been approved by the FDA for use as monotherapy or in combination with paclitaxel for treatment of advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that has progressed on or after platinum- or fluoropyrimidine-based chemotherapy. Ramucirumab is also approved for use in combination with docetaxel (Taxotere, and others) for treatment of metastatic non-small cell lung cancer that has progressed on or after platinum-based...