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Oncology Newsfeed

  • FDA Approves Atezolizumab as Adjuvant Treatment for NSCLC

    On October 15, 2021, U.S. the Food and Drug Administration (FDA) approved atezolizumab for adjuvant treatment following resection and platinum-based chemotherapy in patients with Stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test. 

    Read the FDA announcement.

    Read Roche's announcement.

    Posted 10/18/2021

     


  • FDA Approves Pembrolizumab Combination for Cervical Cancer

    On October 13, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. 

    Read the FDA announcement.

    Read Merck's announcement.

    Posted 10/14/2021



  • FDA Approves Abemaciclib with Endocrine Therapy for Early Breast Cancer

    On October 12, 2021, the U.S. Food and Drug Administration (FDA) approved abemaciclib with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score greater than or equal to 20 percent, as determined by an FDA approved test. 

    Read the FDA announcement.

    Read Eli Lilly and Company's announcement.

    Posted 10/14/21



  • FDA Approves Brexucabtagene Autoleucel for R/R B-Cell Precursor ALL

    On October 1, 2021, the U.S. Food and Drug Administration (FDA) approved brexucabtagene autoleucel for adult patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL).

    Read the FDA announcement.

    Read Kite Pharma's announcement.

    Posted 10/4/2021



  • G1 Therapeutics Announces J-Code for Trilaciclib

    G1 Therapeutics announced the new permanent Healthcare Common Procedure Coding System (HCPCS) J-code for Cosela™ (trilaciclib) issued by the Centers for Medicare & Medicaid Services (CMS). The code J1448 is effective October 1, 2021, for trilaciclib injection of 1mg for provider billing at all sites of care. 

    Read more on the Cosela website or G1 Therapeutics announcement.

    Posted 10/1/2021



  • FDA Expands Cetuximab in Combination Label for Metastatic Colorectal Cancer

    On September 28, 2021, the U.S. Food and Drug Administration (FDA) granted approval of a new indication for cetuximab in combination with encorafenib for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

    Read Eli Lilly's announcement.

    Posted 9/29/2021



  • Anemia ID—a No-Cost Genetic Testing Program for Hereditary Anemias

    Agios Pharmaceuticals' Anemia ID offers no-cost genetic testing to patients in the United States with suspected hereditary anemias. The program is offered in partnership with PerkinElmer Genomics.

    The program "provides a diagnosis confirming the underlying cause(s) of a patient’s hereditary anemia, supports the development of an effective management plan, informs genetic counseling discussions, and enables the identification of appropriate treatment options or clinical trials." 

    Read more about Anemia ID by visiting its website.

    Posted 9/27/2021



  • Bayer Healthcare Shares Latest Analyses of Vitrakvi for Patients with TRK Fusion Cancer

    On September 16, 2021, Bayer Healthcare released data from three subset analyses and one matching-adjusted indirect comparison model for Vitrakvi® (larotrectinib). These reports showcase the product's clinical profile and add to its safety data for patients with solid tumors harboring an NTRK gene fusion, which is also known as TRK fusion cancer.

    Key elements of Bayer's news includes:

    • An updated analyses on three Vitrakvi clinical trials of adult patients with non-central nervous system (CNS) TRK fusion cancer, which showed an overall response rate of 67% and a median duration of response of 49.3 months.
    • A sub-analysis published on the investigator-assessed overall response rate and duration of patients' responses that were stratified.
    • Data on the incidence of fractures from three Phase I and II clinical trials of patients with solid and CNS tumors treated with Vitrakvi monotherapy was also published.
    • Electronic poster of a matching-adjusted indirect comparison that evaluated the efficacy and safety observed in clinical trials with Vitrakvi.

    "These analyses add to the body of evidence for the compound, which has the largest dataset and longest follow-up of any TRK inhibitor," says Bayer. 

    Read more at Bayer Healthcare's website.

    Posted 9/21/2021



  • FDA Grants Accelerated Approval to Tisotumab Vedotin-tftv for Cervical Cancer

    On September 20, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. 

    Read the FDA announcement.

    Read Seagen and Genmab's announcement.

    Posted 9/21/2021



  • FDA Approves Cabozantinib for Locally Advanced or Metastatic DTC

    On September 17, 2021, the U.S. Food and Drug Administration (FDA) approved cabozantinib for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor-targeted therapy and who are radioactive iodine-refractory or ineligible.

    Read the FDA announcement.

    Read Exelixis' announcement.

    Posted 9/20/2021