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Enfortumab Vedotin-ejfv Plus Pembrolizumab Approved for Urothelial Cancer

The FDA has approved enfortumab vedotin-ejfv (Padcev®, Astellas Pharma) in combination with pembrolizumab (Keytruda®, Merck) for patients with locally advanced or metastatic urothelial cancer (UC). The FDA previously granted accelerated approval for this therapy combination for patients with locally advanced or metastatic UC who are ineligible for cisplatin-containing chemotherapy.   Why it matters: "Cisplatin-based combination chemotherapy remains the standard of care for locally advanced ...

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Belzutifan Approved for Advanced Renal Cell Carcinoma

The FDA has approved belzutifan (Welireg™, Merck & Co., Inc.) for advanced renal cell carcinoma (RCC) subsequent to a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).   Why it matters: "Belzutifan is a first-in-class oral hypoxia-inducible factor 2alpha (HIF-2α) inhibitor approved in the US for patients with Von Hippel-Lindau disease–associated RCC, primitive neuroectodermal t...

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Revision of Pembrolizumab Indication for Gastric Cancer

The FDA has amended the existing indication of pembrolizumab (Keytruda®, Merck) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)–positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. While this indication remains approved under the accelerated approval regulations, this revision restricts its use to patients whose tumors e...

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Omidubicel-onlv Approved for Reducing Infection and Time to Neutrophil Recovery in Patients With Hematologic Malignancies

The FDA has approved omidubicel-onlv (Omisirge®, Gamida Cell Ltd.) for treatment of adult and pediatric patients 12 and older with hematologic malignancies, to minimize the time to neutrophil recovery and incidence of infection following myeloablative conditioning for umbilical cord transplantation. Approved population: adults and pediatric patients ≥12 with hematologic malignancies Why it matters: "Early-phase studies have demonstrated that ex vivo expansion of umbilical cord blood (UCB) s...

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Zanubrutinib Approved for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

The FDA has approved zanubrutinib (Brukinsa®, BeiGene USA, Inc.) for treatment of chronic lymphocytic leukemia (CLL) and its tissue counterpart, small lymphocytic lymphoma (SLL). "Zanubrutinib is a next-generation, selective Bruton tyrosine kinase inhibitor with efficacy in relapsed CLL and SLL," wrote Constantine Tam, MD, the Director of Hematology at St. Vincent's Hospital in Melbourne, Australia, and colleagues, in their abstract of the SEQUOIA trial (NCT03336333), one of the studies on which...

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Tremelimumab Plus Durvalumab Approved For Unresectable Hepatocellular Carcinoma

The FDA has granted approval to tremelimumab (Imjudo®, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC). "Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival," remarked Ghassan Abou-Alfa, MD, MBA, an Attending Physician at Memorial Sloan Kettering Cancer Center, and colleagues, regarding the HIMALAYA trial (NCT03298451), on which approval was ...

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