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Oncology Newsfeed

  • FDA Approves Tisagenlecleucel for R/R Follicular Lymphoma

    On May 28, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisagenlecleucel for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma after two or more lines of systemic therapy.

    For more information, read Novartis' announcement.

    Posted 5/31/2022



  • FDA Approves Ivosidenib in Combination for Acute Myeloid Leukemia

    On May 25, 2022, the U.S. Food and Drug Administration (FDA) approved ivosidenib in combination with azacitidine for newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation, as detected by an FDA-approved test, in adults 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy.

    Read the FDA announcement.

    Read Servier's announcement.

    Posted 5/26/2022



  • Eisai Provides Lenvatinib Dose Reductions at No Cost

    On May 10, 2022, it was announced that the Eisai lenvatinib dose exchange program has been expanded to cover all indicated dose reductions for patients with endometrial cancer who require a new prescription. The program will allow dose exchanges for up to 15 days of a patient's current dose for one that is lower, once per quarter, and at no cost.

    For more information, read the news article.

    Posted 5/12/2022



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

    On May 4, 2022, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting, and who have developed disease recurrence during or within six months of completing therapy.

    Read the FDA announcement.

    Read AstraZeneca and Daiichi Sankyo's announcement.

    Posted 5/5/2022


  • ASCO's Guideline Update Includes Oncotype DX in Early-Stage Breast Cancer

    The American Society of Clinical Oncology (ASCO) has updated its 2022 guideline for biomarkers for adjuvant endocrine and chemotherapy in early-stage breast cancer to include the Oncotype DX Breast Recurrence Score® test. This test is recommended for use in postmenopausal patients with up to three positive axillary lymph nodes, irrespective of clinical risk.

    For more information, read Exact Sciences' announcement and the ASCO guideline update.

    Posted 5/2/2022



  • FDA Approves Bevacizumab-maly Biosimilar for Colorectal Cancer

    On Monday, April 18, 2022, the U.S. Food and Drug Administration (FDA) approved Alymsys® (bevacizumab-maly), a biosimilar to Avastin® (bevacizumab). Alymsys' approved indications include:

    • Metastatic colorectal cancer in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment

    • Metastatic colorectal cancer in combination with fluoropyrimidine-irinotecan- or fluoropyrimidineoxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.

    Read Brand Institute's announcement for more information.

    Posted 4/18/2022



  • Secretary of HHS Extends COVID-19 Public Health Emergency

    Effective April 16, 2022, Secretary of Health and Human Services (HHS) Xavier Becerra renewed the COVID-19 public health emergency that has existed nationwide since January 27, 2020.

    For more information, visit the HSS website.

    Posted 4/14/2022



  • FDA Approves Axicabtagene Ciloleucel for Large B-Cell Lymphoma

    On Friday, April 1, 2022, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.

    Read the FDA announcement.

    Read Gilead's announcement.

    Posted 4/4/2022


  • FDA Approves Lutetium Lu 177 Vipivotide Tetraxetan for Prostate Cancer

    On March 23, 2022, the U.S. Food and Drug Administration (FDA) approved lutetium Lu 177 vipivotide tetraxetan for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy. 

    Read the FDA announcement.

    Read Novartis' announcement.

    Posted 3/24/2022



  • FDA Approves Pembrolizumab for Advanced Endometrial Carcinoma

    On March 21, 2022, the U.S. Food and Drug Administration (FDA) approved pembrolizumab as a single agent for patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.

    Read the FDA announcement.

    Read Merck's announcement.

    Posted 3/22/2022