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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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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New Cetuximab Dosing Guidelines Approved for Colorectal Cancer and Head and Neck Cancer

The FDA has approved a new dosing regimen of 500 mg/m2 cetuximab (Erbitux®, Eli Lilly) for patients with KRAS wild-type epidermal growth factor receptor (EGFR)–expressing metastatic colorectal cancer (CRC) and patients with head and neck squamous cell carcinoma (HNSCC). This biweekly dosage regimen serves as an alternative to the existing weekly dosage regimen of cetuximab, whether on its own or combined with chemotherapy, and should be administered as a single 120-minute intravenous infusion ev...
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Isatuximab-Irfc Combination Approved for Multiple Myeloma

The FDA has approved isatuximab-irfc (Sarclisa®, Sanofi) in combination with carfilzomib and dexamethasone (Kd), for adult patients with relapsed or refractory multiple myeloma who have previously received one to three lines of therapy. "Treatment of relapsed/refractory multiple myeloma (RRMM) has greatly improved, yet relapse is inevitable and additional effective treatments are needed," wrote Philippe Moreau, MD, Head of the Hematology Department at the University Hospital of Nantes in France,...
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