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

FDA Approves Nirogacestat for Desmoid Tumors

On November 27, the US Food and Drug Administration (FDA) approved nirogacestat for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approved treatment for desmoid tumors.

For more information read the FDA announcement and the SpringWorks Therapeutic announcement. 

Posted 11/28/2023

FDA Approves Capivasertib + Fulvestrant for Breast Cancer

On November 16, the US Food and Drug Administration (FDA) approved capivasertib in combination with fulvestrant for adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with 1 or more biomarker alterations (PIK3CA, AKT1 or PTEN). Eligible patients will have progressed on at least 1 endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy.

For more information read the FDA announcement and the AstraZeneca announcement. 

Posted 11/17/2023

FDA Approves Pembrolizumab + Chemotherapy for HER2-negative GEJ Junction Adenocarcinoma

On November 16, the US Food and Drug Administration (FDA) approved pembrolizumab in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.

For more information read the FDA announcement and the Merck announcement.

Posted 11/17/2023

FDA Approves Repotrectinib for ROS1-positive NSCLC

On November 15, the US Food and Drug Administration (FDA) approved repotrectinib for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This is the first FDA approval that includes patients with ROS1-positive NSCLC who have previously received a ROS1 tyrosine kinase inhibitor (TKI), in addition to patients who are TKI naïve.

FDA Approves Fruquintinib in Refractory Metastatic Colorectal Cancer

On November 8, the US Food and Drug Administration (FDA) approved fruquintinib for adult patients with metastatic colorectal cancer who received prior fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

For more information read the FDA announcement.

Posted 11/9/2023