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 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 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

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

FDA Expands Selpercatinib Approval for RET Fusion-Positive Solid Tumors

On September 21, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
For more information, read the FDA announcement and the Lilly announcement.
Posted 9/22/2022