Industry News

  • FDA Approves Oral Suspension Ibrutinib in Adults with Chronic Lymphocytic Leukemia & Small Lymphocytic Lymphoma

    On February 24, the US Food and Drug Administration (FDA) approved a label expansion for ibrutinib with an oral suspension formulation for adult patients in the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma. Ibrutinib is now the only Bruton’s tyrosine kinase inhibitor (BTKi) approved with an oral suspension formulation.

    For more information read the Johnson & Johnson announcement.

    Posted 3/21/2024



  • FDA Approves Ponatinib + Chemotherapy for Lymphoblastic Leukemia

    On March 19, the US Food and Drug Administration (FDA) granted accelerated approval to ponatinib in combination with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.

    For more information read the FDA announcement and the Takeda Pharmaceuticals announcement. 

    Posted 3/20/2024



  • FDA Approves Tislelizumabjsgr for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma

    On March 14, the US Food and Drug Administration (FDA) approved tislelizumabjsgr as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. 

    For more information read the BeiGene announcement.

    Posted 3/15/2024



  • Changes to Ropeginterferon alfa-2b-njft in Updated NCCN Clinical Practice Guidelines

    On February 27, PharmaEssentia, announced that the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) have recently been updated to include ropeginterferon alfa-2b-njft, marketed as BESREMi®, as a preferred first-line cytoreductive therapy option for the treatment of adults with symptomatic, low-risk polycythemia vera. 

    For more information read the PharmaEssentia announcement.

    Posted 3/13/2024



  • FDA Approves Zanubrutinib for Relapsed or Refractory Follicular Lymphoma

    On March 7, the US Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib in combination with obinutuzumab for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

    For more information read the FDA announcement and BeiGene announcement. 

    Posted 3/11/2024



  • FDA Approves Nivolumab + Cisplatin and Gemcitabine for Unresectable or Metastatic Urothelial Carcinoma

    On March 6, the US Food and Drug Administration (FDA) approved nivolumab in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. 

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

    Posted 3/11/2024



  • FDA Approves Inotuzumab Ozogamicin for Pediatric Patients with Acute Lymphoblastic Leukemia

    On March 6, the US Food and Drug Administration (FDA) approved inotuzumab ozogamicin for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia. 

    For more information read the FDA announcement. 

    Posted 3/8/2024 



  • FDA Approves Amivantamab-vmjw for Non-small Cell Lung Cancer

    On March 1, the US Food and Drug Administration (FDA) approved amivantamab-vmjw in combination with carboplatin and pemetrexed for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test.

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

    Posted 3/8/2024



  • 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 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



  • 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




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