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Oncology Newsfeed

  • FDA Grants Accelerated Approval to Loncastuximab Tesirine-lpyl for R/R LBCL

    On April 23, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to loncastuximab tesirine-lpyl for adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma.

    Read the FDA announcement.

    Read ADC Therapeutics announcement.

    Posted 4/26/2021



  • FDA Approves Companion Diagnostic for Immunotherapy Eligible Endometrial Cancer

    On April 23, 2021, the U.S. Food and Drug Administration (FDA) approved the Ventana MMR RxDx Panel for patients with advanced or recurrent endometrial cancer. Testing can identify patients eligible for treatment with dostarlimab-gxly, which was also approved by the FDA on April 22, 2021.

    Read Roche's announcement.

    Posted 4/23/2021



  • FDA Grants Accelerated Approval to Dostarlimab-gxly

    On April 22, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly for adult patients with mismatch repair deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen.

    Read the FDA announcement.

    Read the GlaxoSmithKline announcement.

    Posted 4/23/2021



  • Amgen Launches Assistance Program for NSCLC Biomarker Testing

    On April 19, 2021, Amgen announced its launch of Biomarker AssistTM—a program to help patients with metastatic non-small cell lung cancer (NSCLC) gain access to biomarker testing. Through this new program, eligible patients may save on costs related to biomarker testing. 

    Learn more about Biomarker AssistTM on its website.

    Read the Amgen announcement.

    Posted 4/19/2021


  • FDA Approves Nivolumab in Combination with Chemotherapy for Three Indications

    On April 16, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab in combination with certain types of chemotherapy for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

    Read the FDA announcement.

    Read the BMS announcement.

    Posted 4/16/2021



  • FDA Approves Sacituzumab Govitecan-hziy for Urothelial Cancer

    On April 13, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan-hziy for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor.

    Read the FDA announcement.

    Read the Gilead Sciences announcement.

    Posted 4/14/2021



  • FDA Approves Sacituzumab Govitecan-hziy for Triple-Negative Breast Cancer

    On April 7, 2021 the U.S. Food and Drug Administration (FDA) granted regular approval to sacituzumab govitecan-hziy for patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.

    Read the FDA announcement.

    Read the Gilead Sciences announcement.

    Posted 4/8/2021



  • AONN+ Leadership Council Shares Need for Complete Cancer Care Team

    On March 30, 2021, the Academy of Oncology Nurse & Patient Navigators (AONN+) Leadership Council released key reasons why cancer care teams should be protected and thoughtful investment strategies for cancer programs and practices to help remain strong as they recover from the pandemic. After closely reviewing the pandemic's impact on cancer care delivery in 2020, the Leadership Council devised key reasoning for protecting the cancer care team and service line:

    • Newly diagnosed patient volumes will increase along with diagnoses of advanced disease
    • Cancer service line revenues will be impacted if care organization is not streamlined and efficient
    • The navigation team (e.g., navigators, social workers, etc.) will be difficult to reassemble
    • Navigation can address cancer disparities.
    "With new testing and mitigation strategies being implemented and improved access to vaccines on the horizon, now is the time to proactively plan for the near future. With proper and realistic planning, members of the cancer care team can be well-positioned to serve their patients with cancer and their families as the pandemic begins to subside."

    The AONN+ Leadership Council is led by Christian Downs, executive director of the Association of Community Cancer Centers, with support from Linda Fleisher, principal investigator at Fox Chase Cancer Center, Lillie Shockney, co-founder of AONN+, Rani Khetarpal, vice president of Provider Partnerships at New Century Health, and Mandi Pratt-Chapman, associate center director of Patient-Centered Initiatives and Health Equity at George Washington Cancer Center.

    For more information on the Leadership Councils' tips for a strong cancer care team post-pandemic, read the full announcement.

    Posted 4/7/2021



  • FDA Grants Breakthrough Device Designation to miR Scientific Assay

    On October 13, 2020, the U.S. Food and Drug Administration (FDA) granted miR Scientific's miR Sentinel™ PCC4 Assay (miR Sentinel™ Prostate Test) breakthrough device designation. The miR Sentinel™ Prostate Test is a new method to analyze small non-coding RNAs from a non-invasive urine specimen from age-eligible men.

    Read the company's announcement

    Posted 4/6/2021



  • CMS Releases New Billing Codes for April 2021

    The Centers for Medicare & Medicaid Services (CMS) has released six new billing codes for oncology-related products. These codes start April 1, 2021. The products, their associated codes, billing units, and Medicare payment limits are:

    April 2021 New Billing Codes

    Posted 4/5/2021