Pembrolizumab Approved for HER2-Positive Gastric Cancer

The FDA has granted accelerated approval to pembrolizumab (Keytruda®, Merck & Co.) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic HER2- positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. "The PD-1 (programmed cell death protein 1)/PD-L1 (programmed death-ligand 1) pathway is an important regulatory component of the immune response and plays a critica...
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Sacituzumab Govitecan for Advanced Urothelial Cancer: Petros Grivas, MD, PhD

Recently, the FDA granted accelerated approval to sacituzumab govitecan (Trodelvy®, Immunomedics), an antibody-drug conjugate, for patients with locally advanced or metastatic urothelial cancer whose disease progressed following treatment with platinum-containing chemotherapy and a programmed cell death protein 1 (PD-1)/programmed death ligand-1 (PD-L1) inhibitor. In this interview with Oncology Data Advisor, Dr. Petros Grivas, Associate Professor and Clinical Director of the Genitourinary Cance...
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FDA Approves Loncastuximab Tesirine-lpyl for Relapsed/Refractory Large B-Cell Lymphoma

The FDA has granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta™, ADC Therapeutics) for patients with relapsed/refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma, who had two or more lines of systemic therapy. "Loncastuximab tesirine has shown substantial antitumor activity with a manageable toxicity profile in patients with relapsed/refractory DLBC...
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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 Nivolumab With Chemotherapy for Gastric and Esophageal Cancer

The FDA has granted approval to nivolumab (Opdivo®, Bristol-Myers Squibb Company) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the initial treatment of patients with advanced/metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. "Standard first-line chemotherapy options for advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric cancer/gastroesophageal junction cancer result in poor overall su...
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