Industry News

  • 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




1801 Research Boulevard Suite 400
Rockville, MD 20850
Tel: 301.984.9496 | Fax: 301.770.1949
tops-tennessee.com
Email Us