Industry News

  • FDA Expands Early Breast Cancer Indication for Abemaciclib with Endocrine Therapy

    On March 3, 2023, the U.S Food and Drug Administration (FDA) approved an expanded indication for abemaciclib, in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at a high risk of recurrence. 

    For more information read the FDA announcement and the Lilly Oncology announcement

    Posted 3/6/2023



  • FDA Approves Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

    On January 27, 2023, the U.S Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor.

    For more information, read the FDA announcement and the Lilly Oncology announcement.

    Posted 3/3/2023



  • FDA Approves Trodelvy® in Pre-treated HR+/HER2- Metastatic Breast Cancer

    On February 3, 2023, the U.S. Food and Drug Administration (FDA) approved Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

    Click here to review the data.

    Please see full Prescribing Information including BOXED WARNING.

    TRODELVY-123x50  Gilead-125x50

    TRODELVY, the TRODELVY logo, GILEAD, and the GILEAD logo are trademarks of Gilead Sciences, Inc., or its related companies.

    ©2023 Gilead Sciences, Inc. All rights reserved. US-TROP-0782 02/23



  • FDA Approves Sacituzumab Govitecan-hziy for HR-positive Breast Cancer

    On February 3, 2023, the U.S Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy for patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

    For more information, read the FDA announcement and the Gilead announcement.

    Posted 2/6/2023



  • FDA Approves Pembrolizumab as Adjuvant Treatment for NSCLC

    On January 26, 2023, the U.S Food and Drug Administration (FDA) approved pembrolizumab for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC).

    For more information read the FDA announcement and the Merck announcement

    Posted 1/27/2023



  • FDA Approves Zanubrutinib for CLL or SLL

    On January 19, 2023, the U.S Food and Drug Administration (FDA) approved zanubrutinib for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

    For more information, read the FDA announcement and the Beigene announcement

    Posted 1/20/2023



  • FDA Grants Accelerated Approval to Tucatinib with Trastuzumab for Colorectal Cancer

    On January 19, 2023, the U.S Food and Drug Administration (FDA) granted accelerated approval to tucatinib in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

    For more information read the FDA announcement

    Posted 1/20/2023 



  • FDA Approves FoundationOne®Liquid CDx as a Companion Diagnostic for Entrectinib

    Foundation Medicine, Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) for the use of FoundationOne®Liquid CDx as a companion diagnostic to identify patients with ROS1-positive non-small cell lung cancer or patients with NTRK fusion-positive solid tumors, who do not have a tissue sample available and may be appropriate for treatment with entrectinib. 

    For more information, read the Foundation Medicine announcement

    Posted 1/5/2023



  • FDA Updates Capecitabine Indications and Dosing Regimens

    On December 14, 2022, the U.S Food and Drug Administration (FDA) approved updated labeling for capecitabine under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for older, commonly prescribed oncology drugs.

    Capecitabine is now approved for the following new and revised indications:

    • Adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen
    • Perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy
    • Treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen
    • Treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated
    • Treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy
    • Treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen
    • Treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen
    • Adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen.

    Additional labeling revisions include:

    • The dosage regimen is revised and updated for several indications, including the option for a lower starting dose for patients with metastatic breast cancer
    • Severe renal impairment is removed as a contraindication
    • Information on risks from exposure to crushed tablets is added under warnings and precautions
    • Additional information is provided on the use of capecitabine and dihydropyrimidine dehydrogenase (DPD) deficiency
    • Clinical pharmacology information is updated and revised
    • The patient counseling information section and patient information document are updated and revised.

    For more information, read the FDA announcement.

    Posted 12/16/2022



  • FDA Grants Approval to Atezolizumab for Alveolar Soft Part Sarcoma

    On December 9, 2022, the U.S Food and Drug Administration (FDA) approved atezolizumab for adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma.

    For more information read the FDA announcement.

    Posted 12/12/2022




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