Adjuvant Nivolumab Approved for Resected Esophageal and GEJ Cancer

The FDA has granted approval to nivolumab (Opdivo®, Bristol Myers Squibb) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease after prior neoadjuvant chemoradiotherapy. "No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemoradiotherapy and surgery for esophageal or gastroesophageal junction cancer," wrote the investigators of the phase 3 CheckMate 577 trial...
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Dostarlimab-gxly Approved for Recurrent/Advanced Endometrial Cancer

The FDA has granted accelerated approval to dostarlimab-gxly (Jemperli®, GlaxoSmithKline) for patients with mismatch repair deficient recurrent or advanced endometrial cancer that has progressed on or after a prior platinum-containing chemotherapy. "The prognosis for patients with a diagnosis of advanced or recurrent endometrial cancer is poor, and, to our knowledge, there are no accepted consensus-based guidelines for standard of care after the disease progresses while undergoing or after treat...
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FDA Approves Sacituzumab Govitecan for Advanced Urothelial Cancer

Sacituzumab govitecan (Trodelvy®, Immunomedics) has been granted accelerated approval for patients with locally advanced or metastatic urothelial cancer following treatment with platinum–containing chemotherapy and a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitor. "Patients with metastatic urothelial cancer have limited options after progression on platinum and checkpoint inhibitors," wrote the investigators of the phase 2 TROPHY-U-01 study (NCT03547973), on w...
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Cemiplimab Approval for Locally Advanced/Metastatic Basal Cell Carcinoma

Recently, the FDA granted approval to cemiplimab (Libtayo®, Regeneron Pharmaceuticals) for the treatment of patients with locally advanced or metastatic basal cell carcinoma (BCC) who were previously treated with a hedgehog pathway inhibitor (HHI) or who are ineligible for HHI therapy. In this interview, Karl Lewis, MD, Professor of Medical Oncology at the University of Colorado Anschutz Medical Campus and one of the investigators of Study 1620 (NCT03132636), on which the approval was based, spe...
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Cemiplimab-rwlc Approved for Non-Small Cell Lung Cancer With High PD-L1 Expression

The FDA has approved cemiplimab-rwlc (Libtayo®, Regeneron Pharmaceuticals, Inc.), a programmed cell death protein 1 (PD-1) inhibitor, for the first-line treatment of patients with advanced non-small lung cancer cell (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in at least 50% of their cells and whose tumors do not have aberrations in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or C-ROS oncogene 1 (ROS1). "An estimated 25% to 35% of advanced NSCLC ...
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