Industry News

  • FDA Grants Accelerated Approval to Retifanlimab-dlwr for MCC

    On March 22, 2023, the U.S Food and Drug Administration granted accelerated approval to retifanlimab-dlwr for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

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

    Posted 3/22/2023



  • FDA Approves Dabrafenib + trametinib for Pediatric Patients with LGG

    On March 16, 2023, the U.S Food and Drug Administration (FDA) approved dabrafenib with trametinib for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

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

    Posted 3/20/2023



  • 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 Approves FoundationOne Liquid CDx for Some Tyrosine Kinase Inhibitors in NSCLC

    On December 21, Foundation Medicine announced that the U.S. Food and Drug Administration (FDA) approved its FoundationOne®Liquid CDx as a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitutions and are appropriate for treatment with a group of current and future EGFR tyrosine kinase inhibitors approved by the FDA for this indication.

    For more information, read Foundation Medicine's press release.

    Posted 12/21/2022



  • FDA Approves a New Dosing Regimen for Asparaginase Erwinia Chrysanthemi

    On November 18, 2022, the U.S Food and Drug Administration (FDA) approved a new Monday-Wednesday-Friday dosing regimen for asparaginase erwinia chrysanthemi (recombinant)-rywn. Under the new regimen, patients should receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg/m2 intramuscularly on Friday afternoon. 

    For more information, read the FDA announcement.

    Posted 11/21/2022




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