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Oncology Newsfeed

  • FDA Approves Guardant360 CDx for HER2-Mutant NSCLC

    On August 12, 2022, the U.S. Food and Drug Administration (FDA) approved Guardant360® CDx liquid biopsy test as a companion diagnostic (CDx) to select patients with unresectable or metastatic HER2-mutant non-small cell lung cancer (NSCLC), whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, for treatment with AstraZeneca and Daiichi Sankyo's Enhertu® (fam-trastuzumab deruxtecan-nxki).

    For more information, read Guardant Health's announcement.

    Posted 8/15/2022



  • FDA Approvees Fam-Trastuzumab Deruxtecan-nxki for HER2-Mutant NSCLC

    On August 11, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

    For more information, read the FDA announcement or the AstraZeneca and Daiichi Sankyo announcement.

    Posted 8/15/2022



  • FDA Approves Capmatinib for Metastatic NSCLC

    On August 10, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to capmatinib for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test.

    For more information, read the FDA announcement.

    Posted 8/15/2022



  • FDA Approves New Acalabrutinib Formulation

    On August 5, 2022, the U.S. Food and Drug Administration approved the new tablet formulation for acalabrutinib for all current indications, including chronic lymphocytic leukaemia, small lymphocytic lymphoma, and relapsed or refractory mantle cell lymphoma.

    For more information, read AstraZeneca's announcement.

    Posted 8/12/2022



  • AstraZeneca Plans to Withdraw an Olaparib Indication for Ovarian Cancer

    On August 11, 2022, AstraZeneca released a letter stating that that there is a "potential detrimental effect on the overall survival" for olaparib. Therefore, the company has announced it is planning to voluntarily withdraw the olaparib indication for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

    For more information, read the letter sent by AstraZeneca.

    Posted 8/11/2022




  • FDA Approves Label Expansion for VENTANA MMR RxDx Panel

    On August 11, 2022, the U.S Food and Drug Administration (FDA)  approved a label expansion for the VENTANA MMR RxDx Panel, a companion diagnostic test to aid in identifying patients whose solid tumors are deficient in DNA mismatch repair, and who may be eligible for treatment with Keytruda®(pembrolizumab).

    For more information read the Roche announcement.  

    Posted on 8/11/2022



  • FDA Approves Darolutamide + Docetaxel for mHSPC

    On August 5, 2022, the U.S Food and Drug Administration (FDA) approved a supplemental new drug application for darolutamide in combination with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).

    For more information read the FDA announcement and the Bayer announcement

    Posted on 8/8/2022



  • FDA Approves Fam-Trastuzumab-Deruxtecan-nxki for HER2-Low Breast Cancer

    On August 5, 2022, the U.S Food and Drug Administration (FDA) approved fam-trastuzumab-deruxtecan-nxki for the treatment of patients with unresectable or metastatic HER2-low breast cancer.

    For more information, read the FDA announcement .

    Posted on 8/5/2022



  • FDA Approves Crizotinib for ALK-Positive Inflammatory Myofibroblastic Tumor

    On July 14, 2022, the U.S. Food and Drug Administration (FDA) approved crizotinib for adult and pediatric patients at least a year old, with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors. 

    For more information, read the FDA announcement

    Posted on 7/19/2022 



  • CMS Announces CY 2023 HOPPS Proposed Rule

    On July 15, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2023 Medicare Hospital Outpatient Prospective Payment System (HOPPS) proposed rule, including proposals that align with several key goals of the Biden Administration like advancing health equity in rural areas, promoting competition in the healthcare system, and promoting safe, effective, patient-centered care.

    For more information, read the proposed rule and the CMS fact sheet.

    Posted 7/18/2022