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Oncology Newsfeed

  • FDA Grants Accelerated Approval to Umbralisib for Two Indications

    On February 5, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to umbralisib for the following indications:

    • Adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen
    • Adult patients with relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapy.

    Read the FDA announcement.

    Read TG Therapeutics' announcement.

    Posted 2/8/2021



  • FDA Approves Tepotinib for Metastatic NSCLC

    On February 3, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib for adult patients with metastatic non-small cell lung cancer (NSCLC) barboring mesenchymal-epithelial transition exon 14 skipping alterations.

    This indication is approved under accelerated approval based on overall response rate and response duration. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

    Read the FDA announcement.

    Read Merck KGaA's announcement.

    Posted 2/4/21



  • FDA Approves Nivolumab + Cabozantinib for Advanced RCC

    On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma (RCC).

    Read Bristol Myers Squibb's announcement.

    Read the FDA announcement.

    Posted 1/22/2021



  • NCCN Releases New Guidance on COVID-19 Vaccine for Patients with Cancer

    On January 22, 2021, the National Comprehensive Cancer Network (NCCN) released new information providing guidance to cancer care providers for vaccinating people with cancer against COVID-19. The NCCN COVID-19 Vaccine Committee recommends that all people currently in active cancer treatment be vaccinated, with considerations regarding immunosuppression and timing. The committee will also meet regularly to update the released recommendations and new recommendations, as they arise.

    Read the full NCCN: Cancer and COVID-19 Vaccination recommendations and find more NCCN resources on its COVID-19 Resources web page

    Posted 1/21/2021


  • FDA Approves Fam-Trastuzumab Deruxtecan-Nxki for Adenocarcinoma

    On January 15, 2021, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen.

    Read the FDA announcement.

    Read Daiichi Sankyo's announcement.

    Posted 1/19/2021



  • FDA Approves Crizotinib for Children and YA Patients with R/R ALCL

    On January 14, 2021, the U.S. Food and Drug Administration (FDA) approved crizotinib for pediatric patients 1 year of age and older and young adults (YA) with relapsed or refractory (R/R), systemic anaplastic large cell lymphoma (ALCL)  that is ALK-positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive  ALCL.

    Read the FDA announcement.

    Read Pfizer's announcement.

    Posted 1/15/2021



  • CMS Releases C-Code for Belantamab Mafodotin-blmf

    The Centers for Medicare and Medicaid Services (CMS) released the C-code C9369 (injection, belantamab mafodontin-blmf, 0.5 mg) for GlaxoSmitheKline's Blenrep (belantamab mafodotin-blmf), effective January 1, 2021.

    Posted 1/5/2021



  • FDA Approves Osimertinib for the Adjuvant Treatment of EGFRm NSCLC

    On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved osimertinib for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumor resection with curative intent.

    Read the FDA announcement.

    Read AstraZeneca's announcement.

    Posted 12/21/2020


  • FDA Approves Relugolix for Advanced Prostate Cancer

    On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved relugolix for the treatment of adult patients with advanced prostate cancer. It is the first and only oral gonadotropin-releasing hormone receptor antagonist for men with advanced prostate cancer.

    Read the FDA announcement.

    Read Myovant Sciences' announcement.

    Posted 12/21/2020


  • FDA Approves Selinexor for R/R Multiple Myeloma

    On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved selinexor in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior

    therapy. Selinexor was previously approved under the FDA's accelerated approval program for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

    Read the FDA announcement.

    Read Karyopharm Therapeutics' announcement.

    Posted 12/21/2020