Industry News Archive

  • 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 who have 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.

    Posted 9/22/2022



  • FDA Approves Durvalumab for Locally Advanced or Metastatic Biliary Tract Cancer

     On September 2, 2022, the U.S Food and Drug Administration (FDA) durvalumab in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer. 

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

    Posted 9/8/2022

     



  • GSK Shares Plans to Voluntarily Withdraw Niraparib

    GSK (GlaxoSmithKline) is planning to voluntarily withdraw the indication of niraparib for treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency positive status.

    For more information read the GSK letter.

    Posted 9/7/2022



  • CMS Delays Radiation Oncology Model For Further Rulemaking

    On August 29, 2022, the Centers for Medicare & Medicaid Services (CMS) published a final rule (CMS-5527-F2) that finalized delaying the Radiation Oncology Model start date until a date is determined through future rulemaking.

    For more information, visit the Radiation Oncology Model website.

    Posted 8/30/2022



  • FDA Approves Ibrutinib for Pediatric Patients with Chronic Graft Versus Host Disease

    On August 24, 2022, the U.S  Food and Drug Administration (FDA) approved ibrutinib for the treatment of pediatric patients one year and older with chronic graft versus host disease after failure of one or more lines of systemic therapy. 

    For more information, read the FDA announcement

    Posted 8/25/2022



  • 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



  • Important Update: Olaparib in 4th Line Treatment of Ovarian Cancer

    AstraZeneca has issued a letter with plans to withdraw its indication for olaparib (Lynparza) 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. This planned withdrawal will not affect any of the maintenance therapy indications for olaparib or olaparib-based combinations.

    Read the letter

    Posted on 08/11/2022


  • 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 8/5/2022




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