Industry News

  • FDA Approves Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer

    On April 29, the US Food and Drug Administration (FDA) granted traditional approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin-tftv previously received accelerated approval for this indication.

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

    Posted 4/30/2024



  • FDA Approves Lutetium Lu 177 Dotatate for Pediatric Patients with Astroenteropancreatic Neuroendocrine Tumors

    On April 23, the US Food and Drug Administration (FDA) approved lutetium Lu 177 dotatate for pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.

    For more information read the FDA announcement.

    Posted 4/24/2024



  • FDA Approves Nogapendekin Alfa Inbakicept-pmln for Invasive Bladder Cancer

    On April 22, the US Food and Drug Administration approved nogapendekin alfa inbakicept-pmln in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.

    For more information read the FDA announcement.

    Posted 4/23/2024



  • FDA Approves Alectinib for ALK-positive Non-Small Cell Lung Cancer

    On April 18, the US Food and Drug Administration (FDA) approved alectinib for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase-positive non-small cell lung cancer, as detected by an FDA-approved test.

    For more information read the FDA announcement and the Genentech Inc. announcement. 

    Posted 4/18/2024



  • FDA Approves Idecabtagene vicleucel for Relapsed or Refractory Multiple Myeloma

    On April 4, the US Food and Drug Administration (FDA) approved idecabtagene vicleucel for the treatment of adult patients with relapsed or refractory multiple myeloma after 2 or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. 

    For more information read the Bristol Myers Squibb announcement.

    Posted 4/9/2024



  • FDA Approves Fam-trastuzumab deruxtecan-nxki for Unresectable or Metastatic HER2-positive Solid Tumors

    On April 5, the US Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

    For more information read the FDA announcement.

    Posted 4/8/2024



  • FDA Approves Mirvetuximab Soravtansine-gynx for Certain Ovarian Cancers

    On March 22, the US Food and Drug Administration (FDA) approved mirvetuximab soravtansine-gynx for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received 1 to 3 prior systemic treatment regimens. 

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

    Posted 3/25/2024



  • 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




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