Industry News

FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma

On February 16, the US Food and Drug Administration (FDA) granted accelerated approval to lifileucel, a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.
For more information read the FDA announcement and the Iovance Biotherapeutics, Inc. announcement.
Posted 2/19/2024

FDA Approves Tepotinib for Metastatic non-small Cell Lung Cancer

On February 15, the US Food and Drug Administration (FDA) granted traditional approval to tepotinib for adult patients with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition exon 14 skipping alterations.
For more information read the FDA announcement.
Posted 2/16/2024

FDA Approves Irinotecan Liposome for First-line Treatment of Metastatic Pancreatic Adenocarcinoma

On February 13, the US Food and Drug Administration (FDA) approved irinotecan liposome in combination with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.
For more information read the FDA announcement.
Posted 2/13/2024

FDA Approves Erdafitinib for Locally Advanced or Metastatic Urothelial Carcinoma

On January 19, the US Food and Drug Administration (FDA) approved erdafitinib for adult patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy.
For more information read the FDA announcement and the Janssen announcement.
Posted 1/22/2024

FDA Approves Pembrolizumab + CRT for FIGO 2014 Stage III-IVA Cervical Cancer

On January 12, the US Food and Drug Administration (FDA) approved pembrolizumab with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer.
For more information read the FDA announcement and the Merck announcement.
Posted 1/15/2024

FDA Approves Iptacopan for Patients with Paroxysmal Nocturnal Hemoglobinuria

On December 5, the US Food and Drug Administration (FDA) approved iptacopan—offering superior hemoglobin improvement in the absence of transfusions—as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria.
For more information read the Novartis announcement.
Posted 12/18/2023

FDA Approves Enfortumab vedotin-ejfv + Pembrolizumab for Locally Advanced or Metastatic Urothelial Cancer

On December 15, the US Food and Drug Administration (FDA) approved enfortumab vedotin-ejfv in combination with pembrolizumab for patients with locally advanced or metastatic urothelial cancer.
For more information read the FDA announcement, Astellas Pharma announcement, and Merck announcement.
Posted 12/18/2023

FDA Approves Belzutifan for Advanced Renal Cell Carcinoma

On December 14, the US Food and Drug Administration (FDA) approved belzutifan for patients with advanced renal cell carcinoma following 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).
For more information read the FDA announcement and the Merck announcement.
Posted 12/18/2023

FDA Approves Eflornithine for Adult and Pediatric Patients with HRNB

On December 13, the US Food and Drug Administration (FDA) approved eflornithine to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.
For more information read the FDA announcement and the US WorldMeds announcement.
Posted 12/18/2023

FDA Approves pirtobrutinib for Chronic Lymphocytic Leukemia + Small Lymphocytic Lymphoma

On December 1, the US Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least 2 prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
For more information read the FDA announcement and the Eli Lilly announcement.
Posted 12/4/2023