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Oncology Newsfeed

  • 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



  • FDA Approves Mobocertinib for NSCLC with EGFR Exon 20 Insertion Mutations

    On September 15, 2021, the U.S. Food and Drug Administration (FDA) approved mobocertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

    Read the FDA announcement.

    Read Takeda's announcement.

    Posted 9/16/2021



  • FDA Grants Accelerated Approval to Zanubrutinib for R/R MZL

    On September 15, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.

    Read the FDA announcement.

    Read BeiGene's announcement.

    Posted 9/15/2021



  • FDA Approves Zanubrutinib for Waldenström’s Macroglobulinemia

    On August 31, 2021, the U.S. Food and Drug Administration (FDA) approved zanubrutinib for adult patients with Waldenström’s macroglobulinemia.

    Read the FDA announcement.

    Read BeiGene's announcement.

    Posted 9/7/2021



  • FDA Approves Updated Pembrolizumab Indication for UC

    On August 31, 2021, the U.S. Food and Drug Administration (FDA) approved a label update to pembrolizumab for first-line advanced urothelial carcinoma (UC). This approval converts the accelerated approval of pembrolizumab to a regular approval.

    Read Merck's announcement.

    Posted 9/1/2021


  • FDA Approves Companion Diagnostic for IDH1-Mutated Cholangiocarcinoma

    On August 25, 2021, the U.S. Food and Drug Administration (FDA) granted pre-market approval to Oncomine Dx Target Test as a companion diagnostic to identify patients with isocitrate dehydrogenase-1 (IDH1) mutated cholangiocarcinoma who may be candidates for Tibsovo® (ivosidenib) (Servier Pharmaceuticals).

    Read the Thermo Fisher Scientific announcement.

    Posted 8/27/2021


  • FDA Approves Ivosidenib for IDH1-Mutated Cholangiocarcinoma

    On August 25, 2021, Servier Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approved ivosidenib for the treatment of adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved test. 

    Read the FDA announcement.

    Read Servier Pharmaceuticals' announcement.

    Posted 8/26/2021