Industry News

  • FDA Approves Osimertinib + Chemotherapy for EGFR-mutated Non-small Cell Lung Cancer

    On February 16, the US Food and Drug Administration (FDA) approved osimertinib in combination with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

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

    Posted 2/19/2024



  • 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 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.

    For more information read the FDA announcement and the Bristol Myers Squibb announcement

    Posted 11/17/2023



  • 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



  • FDA Approves Pembrolizumab with Chemotherapy for Biliary Tract Cancer

    On October 31, the US Food and Drug Administration (FDA) approved pembrolizumab to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer. 

    For more information read the FDA announcement and Merck announcement

    Posted 11/1/2023

     



  • FDA Approves Toripalimab-tpzi for Nasopharyngeal Carcinoma

    On October 27, the US Food and Drug Administration (FDA) approved toripalimab-tpzi in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma. The FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic nasopharyngeal carcinoma with disease progression on or after a platinum-containing chemotherapy.

    For more information read the FDA announcement and the Coherus BioSciences announcement

    Posted 11/1/2023



  • FDA Approves Ivosidenib for Myelodysplastic Syndromes

    On October 24, the US Food and Drug Administration approved ivosidenib for adult patients with relapsed or refractory myelodysplastic syndromes with a susceptible isocitrate dehydrogenase-1 mutation, as detected by an FDA-approved test.

    For more information read the FDA announcement.

    Posted 10/27/2023



  • FDA Expands Pediatric Indication for Entrectinib and Approves New Pellet Formulation

    On October 20, 2023, the US Food and Drug Administration (FDA) granted accelerated approval to entrectinib for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity and have progressed following treatment or have no satisfactory standard therapy.

    For more information read the FDA announcement.

    Posted 10/20/2023 



  • FDA Approves Nivolumab for Adjuvant Treatment of Stage IIB/C Melanoma

    On October 13, the US Food and Drug Administration (FDA) approved nivolumab for the adjuvant treatment of completely resected Stage IIB/C melanoma in patients 12 years and older.

    For more information read the FDA announcement and the Bristol-Myers Squibb announcement

    Posted 10/16/2023




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