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    As Oncology Nurses, We Are the Fish
    Oncology nurse pride
    As Oncology Nurses, We Are the Fish
    May 20, 2022
    Patients and the Public Recognize and Thank Dedicated Nurses
    Nurse empowerment
    Patients and the Public Recognize and Thank Dedicated Nurses
    May 06, 2022
    How to Promote and Maintain Cancer Screening as COVID-19 Persists
    Cancer screening
    How to Promote and Maintain Cancer Screening as COVID-19 Persists
    March 18, 2022
    I’m a Match: My Journey From Advanced Practice BMT Nurse to Stem Cell Transplant Donor
    Oncology nurse pride
    I’m a Match: My Journey From Advanced Practice BMT Nurse to Stem Cell Transplant Donor
    February 11, 2022
    Online and Mobile Resources Prepare Oncology Professionals for Care Delivery in All Settings
    Oncology nurse pride
    Online and Mobile Resources Prepare Oncology Professionals for Care Delivery in All Settings
    January 31, 2022
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    Oncology drug research

    Oncology Drug Reference Sheet: Belumosudil
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Belumosudil

    Chronic graft-versus-host disease (GVHD) is a severe adverse reaction after allogeneic hematopoietic cell transplantation that decreases quality of life and is a major cause of death. In July 2021, the U.S. Food and Drug Administration approved belumosudil (RezurockTM) as a third-line treatment option for chronic GVHD.

    May 24, 2022
    FDA Approves Azacitidine for Newly Diagnosed Juvenile Myelomonocytic Leukemia
    U.S. Food and Drug Administration (FDA)

    FDA Approves Azacitidine for Newly Diagnosed Juvenile Myelomonocytic Leukemia

    On May 20, 2022, the U.S. Food and Drug Administration (FDA) approved azacitidine (Vidaza®) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML).

    May 23, 2022
    FDA Grants Regular Approval to Fam-Trastuzumab Deruxtecan-Nxki for Breast Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Grants Regular Approval to Fam-Trastuzumab Deruxtecan-Nxki for Breast Cancer

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

    May 06, 2022
    Oncology Drug Reference Sheet: Avapritinib
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Avapritinib

    First approved by the U.S. Food and Drug Administration in 2020 for treatment of gastrointestinal stromal tumors (GIST), avapritinib’s (AyvakitTM) approval was extended in 2021 for treatment of advanced systemic mastocytosis (AdvSM). Both approvals are for patients with PDGFR-alpha genetic variants.

    April 26, 2022
    FDA Approves Alpelisib for PIK3CA-Related Overgrowth Spectrum
    U.S. Food and Drug Administration (FDA)

    FDA Approves Alpelisib for PIK3CA-Related Overgrowth Spectrum

    On April 5, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to alpelisib (Vijoice®) for adult and pediatric patients aged two and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy.

    April 07, 2022
    FDA Approves Axicabtagene Ciloleucel for Second-Line Treatment of Large B-Cell Lymphoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Axicabtagene Ciloleucel for Second-Line Treatment of Large B-Cell Lymphoma

    On April 1, 2022, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel (Yescarta®) for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for the treatment of patients with primary central nervous system lymphoma.

    April 05, 2022
    FDA Approves Lutetium Lu 177 Vipivotide Tetraxetan for Metastatic Castration-Resistant Prostate Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Lutetium Lu 177 Vipivotide Tetraxetan for Metastatic Castration-Resistant Prostate Cancer

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

    March 24, 2022
    FDA Approves Pembrolizumab for Advanced Endometrial Carcinoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Pembrolizumab for Advanced Endometrial Carcinoma

    On March 21, 2022, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) as a single agent for patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) advanced endometrial carcinoma, 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.

    March 22, 2022
    Oncology Drug Reference Sheet: Pafolacianine
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Pafolacianine

    An optical imaging agent shown to improve diagnostic accuracy, pafolacianine (CytaluxTM) was approved on November 29, 2021, for use in adult patients with known or suspected ovarian cancer as adjunct therapy in conjunction with planned intraoperative identification of malignant lesions. Pafolacianine is used in combination with a near-infrared (NIR) fluorescence imaging system that requires specialized training provided by the device manufacturer.

    March 22, 2022
    FDA Approves Nivolumab and Relatlimab-Rmbw for Unresectable or Metastatic Melanoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Nivolumab and Relatlimab-Rmbw for Unresectable or Metastatic Melanoma

    On March 18, 2022, the U.S. Food and Drug Administration (FDA) approved nivolumab and relatlimab-rmbw (Opdualag™) for adult and pediatric patients aged 12 years or older with unresectable or metastatic melanoma. Nivolumab and relatlimab-rmbw is a fixed-dose combination of the LAG-3–blocking antibody relatlimab and the programmed death receptor-1–blocking antibody nivolumab.

    March 21, 2022
    FDA Approves Olaparib for Adjuvant Treatment of High-Risk Early Breast Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Olaparib for Adjuvant Treatment of High-Risk Early Breast Cancer

    On March 11, 2022, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza®) for adult patients with deleterious or suspected deleterious germline BRCA variant (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients are selected for therapy based on an FDA-approved companion diagnostic for olaparib.

    March 18, 2022
    FDA Approves Ciltacabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Ciltacabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma

    On February 28, 2022, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti™) for adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. Ciltacabtagene autoleucel is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy.

    March 18, 2022
    FDA Approves Neoadjuvant Nivolumab and Platinum-Doublet Chemotherapy for Early-Stage Non-Small Cell Lung Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Neoadjuvant Nivolumab and Platinum-Doublet Chemotherapy for Early-Stage Non-Small Cell Lung Cancer

    On March 4, 2022, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo®) with platinum-doublet chemotherapy for adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting, representing the first FDA approval for neoadjuvant therapy for early-stage NSCLC.

    March 18, 2022
    FDA Reports Recall of 0.9% Sodium Chloride for Injection USP 250 ml in Excel Because of Fluid Leakage or Low Fill Volume
    U.S. Food and Drug Administration (FDA)

    FDA Reports Recall of 0.9% Sodium Chloride for Injection USP 250 ml in Excel Because of Fluid Leakage or Low Fill Volume

    On March 3, 2022, the U.S. Food and Drug Administration (FDA) reported B. Braun Medical’s voluntary recall of five lots of 0.9% sodium chloride for injection USP 250 ml in Excel within the United States at the hospital and user levels after receiving reports of fluid leakage or low fill volumes.

    March 14, 2022
    Oncology Drug Reference Sheet: Tisotumab Vedotin-Tftv
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Tisotumab Vedotin-Tftv

    In clinical trials, 24% of patients achieved an objective response rate with tisotumab vedotin-tftv (TivdakTM) that lasted a median of 8.3 months, leading to the agent’s U.S. Food and Drug Administration September 2021 approval for use in adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

    February 22, 2022
    Nursing Considerations for Isatuximab Combination Therapy
    Combination therapy

    Nursing Considerations for Isatuximab Combination Therapy

    Clinicians often use combination cancer therapies to overcome treatment resistance, and one of the newest options for certain patients with multiple myeloma is isatuximab, a monoclonal antibody (mAb). Approved for use in combination with pomalidomide plus dexamethasone to treat adults with relapsed or refractory multiple myeloma who have received at least two prior therapies, isatuximab prolonged progression-free survival by nearly six months and produced an overall response rate of more than 60% in the drug’s clinical trials.

    February 08, 2022
    Oncology Drug Reference Sheet: Ivosidenib
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Ivosidenib

    Adding to its earlier approvals for use in adults with acute myeloid leukemia (AML), on August 25, 2021, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo®) for adults with previously treated, locally advanced or metastatic cholangiocarcinoma. Cholangiocarcinoma, or cancer of the bile ducts, is a rare cancer, and ivosidenib is the only currently approved agent for patients with an IDH1 variant.

    January 25, 2022
    Oncology Drug Reference Sheet: Amivantamab-Vmjw
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Amivantamab-Vmjw

    After clinical trials demonstrated a 40% overall response rate with 63% of responses lasting six months or more, on May 21, 2021, the U.S. Food and Drug Administration (FDA) approved amivantamab-vmjw (RybrevantTM) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion variants, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.

    December 28, 2021
    FDA Approves Abatacept for Prophylaxis of Acute Graft-Versus-Host Disease
    U.S. Food and Drug Administration (FDA)

    FDA Approves Abatacept for Prophylaxis of Acute Graft-Versus-Host Disease

    On December 15, 2021, the U.S. Food and Drug Administration (FDA) approved abatacept (Orencia®) for prophylaxis of acute graft-versus-host disease (aGVHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediatric patients aged 2 and older who are undergoing hematopoietic stem cell transplantation (HSCT) from a matched or one allele-mismatched unrelated donor.

    December 16, 2021
    Help Patients Understand Biomarker Test Results and Clinical Trials Options
    Genetics & genomics

    Help Patients Understand Biomarker Test Results and Clinical Trials Options

    Many of today’s new drug approvals and standard-of-care treatments have a companion diagnostic test that identifies biomarkers in a patient’s tumor tissue or blood to determine whether they are an appropriate candidate for the therapy. When those results show that they’re not a good match for the U.S. Food and Drug Administration (FDA)-approved treatment, the findings may identify a biomarker-directed clinical trial as an alternative option. Here’s how oncology nurses can help patients understand which clinical trials listed on their test results might be an option for them.

    December 16, 2021
    Not Eligible for Trials? Expanded Access May Give Patients Options for Investigational Products
    Oncology clinical trials

    Not Eligible for Trials? Expanded Access May Give Patients Options for Investigational Products

    The U.S. Food and Drug Administration’s (FDA’s) expanded access program is a pathway for providers to request using an investigational medical product to treat a patient with an immediately life-threatening or serious disease or condition outside of clinical trials when no comparable or satisfactory alternative therapy options are available. FDA’s Project Facilitate, a comprehensive program within FDA’s Oncology Center of Excellence, makes the pathway more accessible by assisting oncology healthcare professionals in submitting single-patient oncology expanded access applications.

    December 07, 2021
    FDA Approves Rituximab Plus Chemotherapy for Pediatric Cancer Indications
    U.S. Food and Drug Administration (FDA)

    FDA Approves Rituximab Plus Chemotherapy for Pediatric Cancer Indications

    On December 2, 2021, the U.S. Food and Drug Administration (FDA) approved rituximab (Rituxan®) in combination with chemotherapy for pediatric patients aged at least 6 months to 18 years with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia. 

    December 03, 2021
    FDA Approves Daratumumab Hyaluronidase-Fihj, Carfilzomib, Dexamethasone for Multiple Myeloma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Daratumumab Hyaluronidase-Fihj, Carfilzomib, Dexamethasone for Multiple Myeloma

    On November 30, 2021, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro™), carfilzomib (Kyprolis®), and dexamethasone for adult patients with relapsed or refractory multiple myeloma who received one to three prior lines of therapy.

    December 01, 2021
    FDA Approves Sirolimus Protein-Bound Particles for Malignant Perivascular Epithelioid Cell Tumor
    U.S. Food and Drug Administration (FDA)

    FDA Approves Sirolimus Protein-Bound Particles for Malignant Perivascular Epithelioid Cell Tumor

    On November 22, 2021, the U.S. Food and Drug Administration (FDA) approved sirolimus protein-bound particles for injectable suspension (Fyarro™) for adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

    November 23, 2021
    Oncology Drug Reference Sheet: Sotorasib
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Sotorasib

    After clinical trials demonstrated an overall response rate of 36% and median response duration of 10 months, the U.S. Food and Drug Administration granted sotorasib (LumakrasTM) accelerated approval on May 28, 2021, for the treatment of adults with KRAS G12C–altered locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

    November 23, 2021
    FDA Approves Asciminib for Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
    U.S. Food and Drug Administration (FDA)

    FDA Approves Asciminib for Philadelphia Chromosome-Positive Chronic Myeloid Leukemia

    On October 29, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to asciminib (Scemblix®) for patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) who were previously treated with two or more tyrosine kinase inhibitors (TKIs). FDA also approved asciminib for adult patients with Ph+ CML in CP with the T315I variation.

    November 01, 2021
    Oncology Drug Reference Sheet: Belantamab Mafodotin-Blmf
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Belantamab Mafodotin-Blmf

    A first-of-its-kind antibody-drug conjugate for multiple myeloma, belantamab mafodotin-blmf (Blenrep) received accelerated approval from the U.S. Food and Drug Administration (FDA) in August 2020. The approval was based on clinical trial findings that demonstrated a 31% overall response rate that lasted at least six months in 73% of responders.

    October 26, 2021
    FDA Approves Atezolizumab as Adjuvant Treatment for Non-Small Cell Lung Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Atezolizumab as Adjuvant Treatment for Non-Small Cell Lung Cancer

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

    October 15, 2021
    FDA Approves Pembrolizumab Combination for First-Line Treatment of Cervical Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Pembrolizumab Combination for First-Line Treatment of Cervical Cancer

    On October 13, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) 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. 

    October 13, 2021
    FDA Approves Abemaciclib With Endocrine Therapy for Early Breast Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Abemaciclib With Endocrine Therapy for Early Breast Cancer

    On October 12, 2021, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio®) 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 for recurrence and a Ki-67 score ≥ 20%, as determined by an FDA-approved test. This is the first CDK4/6 inhibitor approved for adjuvant treatment of breast cancer.  

    October 13, 2021
    Radioprotectant May Also Be a Radiobooster
    Radiation therapy

    Radioprotectant May Also Be a Radiobooster

    Initially studied for its radioprotective effects on healthy cells, avasopasem may also increase cancer cells’ response to radiation treatment, researchers reported in Science Translational Medicine.

    October 06, 2021
    FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
    U.S. Food and Drug Administration (FDA)

    FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory B-Cell Precursor Acute Lymphoblastic Leukemia

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

    October 04, 2021
    Oncology Drug Reference Sheet: Sacituzumab Govitecan-Hziy
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Sacituzumab Govitecan-Hziy

    Initially marketed in April 2020 for treatment of adults with metastatic triple negative breast cancer, sacituzumab govitecan-hziy (Trodelvy®) received an additional approval in 2021 for the treatment of patients with locally advanced or metastatic urothelial cancer with prior treatments.

    September 28, 2021
    FDA Approves Ruxolitinib for Chronic Graft-Versus-Host Disease
    U.S. Food and Drug Administration (FDA)

    FDA Approves Ruxolitinib for Chronic Graft-Versus-Host Disease

    On September 22, 2021, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Jakafi®) for chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older.

    September 23, 2021
    FDA Approves Cabozantinib for Differentiated Thyroid Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Cabozantinib for Differentiated Thyroid Cancer

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

    September 22, 2021
    FDA Grants Accelerated Approval to Tisotumab Vedotin-Tftv for Recurrent or Metastatic Cervical Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Tisotumab Vedotin-Tftv for Recurrent or Metastatic Cervical Cancer

    On September 20, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv (Tivdak™), a tissue factor-directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer whose disease has progressed on or after chemotherapy.

    September 21, 2021
    FDA Grants Accelerated Approval to Mobocertinib for Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Variants
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Mobocertinib for Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Variants

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

    September 16, 2021
    FDA Approves Zanubrutinib for Waldenström Macroglobulinemia
    U.S. Food and Drug Administration (FDA)

    FDA Approves Zanubrutinib for Waldenström Macroglobulinemia

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

    September 02, 2021
    FDA Approves Ivosidenib for Advanced or Metastatic Cholangiocarcinoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Ivosidenib for Advanced or Metastatic Cholangiocarcinoma

    On August 25, 2021, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo®) for adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. FDA also approved the Oncomine Dx Target Test as a companion diagnostic device to aid in selecting patients with cholangiocarcinoma for treatment with ivosidenib.

    August 26, 2021
    Oncology Drug Reference Sheet: Tivozanib
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Tivozanib

    On March 10, 2021, the U.S. Food and Drug Administration approved tivozanib (Fotivda®), an oral kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

    August 24, 2021
    FDA Approves Nivolumab for Adjuvant Treatment of Urothelial Carcinoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Nivolumab for Adjuvant Treatment of Urothelial Carcinoma

    On August 19, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo®) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk for recurrence after undergoing radical resection.

    August 23, 2021
    FDA Expands Recall to Include Four Additional Lots of Varenicline Tablets Because of N-Nitroso Varenicline Content
    U.S. Food and Drug Administration (FDA)

    FDA Expands Recall to Include Four Additional Lots of Varenicline Tablets Because of N-Nitroso Varenicline Content

    On August 16, 2021, the U.S. Food and Drug Administration (FDA) reported Pfizer’s voluntary recall of an additional four lots of varenicline 0.5mg/1 mg tablets to the patient level because of the presence of N-nitroso-varenicline, a nitrosamine, above the Pfizer-established acceptable daily intake level. To date, Pfizer has not received any reports of adverse events that have been related to the recall. FDA reported Pfizer’s recall of 12 lots of varenicline tablets because of N-nitroso varenicline content on July 19, 2021.

    August 19, 2021
    FDA Grants Accelerated Approval to Dostarlimab-gxly for dMMR Advanced Solid Tumors
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Dostarlimab-gxly for dMMR Advanced Solid Tumors

    On August 17, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli®) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

    August 18, 2021
    FDA Approves Lenvatinib and Pembrolizumab for Advanced Renal Cell Carcinoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Lenvatinib and Pembrolizumab for Advanced Renal Cell Carcinoma

    On August 10, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of lenvatinib (Lenvima®) and pembrolizumab (Keytruda®) for first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

    August 13, 2021
    FDA Approves Belzutifan for Cancers Associated With Von Hippel-Lindau Disease
    U.S. Food and Drug Administration (FDA)

    FDA Approves Belzutifan for Cancers Associated With Von Hippel-Lindau Disease

    On August 13, 2021, the U.S. Food and Drug Administration (FDA) approved belzutifan (Welireg®), a hypoxia-inducible factor inhibitor for adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), that do not require immediate surgery.

    August 13, 2021
    FDA Alerts About Possible Increased Risk of Death Associated With Melphalan Flufenamide
    U.S. Food and Drug Administration (FDA)

    FDA Alerts About Possible Increased Risk of Death Associated With Melphalan Flufenamide

    On July 28, 2021, the U.S. Food and Drug Administration (FDA) reported that a clinical trial (OCEAN, Study OP-103) evaluating melphalan flufenamide (Pepaxto®) with dexamethasone to treat patients with multiple myeloma showed an increased risk of death. 

    July 29, 2021
    FDA Approves Pembrolizumab for High-Risk, Early-Stage, Triple-Negative Breast Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Pembrolizumab for High-Risk, Early-Stage, Triple-Negative Breast Cancer

    On July 26, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and continued as a single agent as adjuvant treatment after surgery. 

    July 27, 2021
    Oncology Drug Reference Sheet: Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf Subcutaneous Injection
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf Subcutaneous Injection

    Pertuzumab, trastuzumab, and hyaluronidase-zzxf subcutaneous injection (PhesgoTM) was approved by the U.S. Food and Drug Administration (FDA) in June 2020 for patients with advanced HER2-positive breast cancer. The drug components are the same as those in FDA-approved IV version, and study results showed comparable safety and efficacy to the IV counterparts. The new administration route allows eligible patients to bypass infusion centers or even receive the therapy at home.

    July 27, 2021
    FDA Grants Regular Approval to Pembrolizumab and Lenvatinib for Advanced Endometrial Carcinoma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Regular Approval to Pembrolizumab and Lenvatinib for Advanced Endometrial Carcinoma

    On July 21, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) in combination with lenvatinib (Lenvima®) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting, and are not candidates for curative surgery or radiation. 

    July 23, 2021
    Biden-Harris Administration’s Drug Policy Priorities Support Prevention, Treatment, and Recovery
    Patient advocacy

    Biden-Harris Administration’s Drug Policy Priorities Support Prevention, Treatment, and Recovery

    Prescription overdoses and addiction rates have dramatically increased in the United States since 2012, with more than 70,000 deaths attributed to the abuse of fentanyl, opioids, cocaine, and methamphetamine in 2019, a 35% increase since 2015. Addressing drug misuse is a top priority for the Biden-Harris administration, as well as researching systematic inequities in the country’s approach to criminal justice and prevention, treatment, and recovery.

    July 21, 2021
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