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 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 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 Approves Tremelimumab with Durvalumab + Chemotherapy for Metastatic NSCLC

    On November 10, 2022, the U.S Food and Drug Administration (FDA) approved tremelimumab in combination with durvalumab and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor mutation or anaplastic lymphoma kinase genomic tumor aberrations.

    For more information, read the FDA announcement.

    Posted 11/15/2022



  • FDA Approves Cemiplimab + Chemotherapy for NSCLC

    On November 8, 2022, the U.S Food and Drug Administration (FDA) approved cemiplimab-rwlc in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.

    For more information, read the FDA Announcement and the Regeneron press release.

    Posted 11/9/2022



  • FDA Approves Tremelimumab in Combination with Durvalumab for Unresectable HCC

    On October 21, 2022, the U.S Food and Drug Administration (FDA) approved tremelimumab in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (HCC). 

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

    Posted 10/24/2022




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