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    The Case of the Cord Blood Match
    Clinical practice
    The Case of the Cord Blood Match
    March 26, 2021
    Empower Recent Graduate Nurses to Be Patient Advocates
    Nurse empowerment
    Empower Recent Graduate Nurses to Be Patient Advocates
    March 19, 2021
    Shared Governance Committees Empower Nurses to Use Their Voice
    Nurse empowerment
    Shared Governance Committees Empower Nurses to Use Their Voice
    March 12, 2021
    Nursing Students Connect Beyond the Classroom With ONS Resources
    Nursing education
    Nursing Students Connect Beyond the Classroom With ONS Resources
    March 05, 2021
    COVID-19 Affects Cancer Caregivers, but Here Are Ways to Support Them
    COVID-19
    COVID-19 Affects Cancer Caregivers, but Here Are Ways to Support Them
    February 19, 2021
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    Oncology drug research

    FDA Grants Accelerated Approval to Sacituzumab Govitecan for Advanced Urothelial Cancer
    Clinical practice

    FDA Grants Accelerated Approval to Sacituzumab Govitecan for Advanced Urothelial Cancer

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

    April 14, 2021
    FDA Approves Sacituzumab Govitecan for Triple-Negative Breast Cancer
    Clinical practice

    FDA Approves Sacituzumab Govitecan for Triple-Negative Breast Cancer

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

    April 08, 2021
    FDA Approves New Cetuximab Dosing Regimen for Colorectal Cancer and Squamous Cell Carcinoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves New Cetuximab Dosing Regimen for Colorectal Cancer and Squamous Cell Carcinoma

    On April 6, 2021, the U.S. Food and Drug Administration (FDA) approved a new dosage regimen for cetuximab (Erbitux®) of 500 mg/m2 via IV infusion for 120 minutes every two weeks for patients with KRAS wild-type, epidermal growth factor receptor-expressing colorectal cancer or squamous cell carcinoma of the head and neck.

    April 07, 2021
    FDA Approves Isatuximab-Irfc for Multiple Myeloma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Isatuximab-Irfc for Multiple Myeloma

    On March 31, 2021, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa®) in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. 

    April 01, 2021
    FDA Approves Idecabtagene Vicleucel as the First Cell-Based Gene Therapy for Adult Patients With Multiple Myeloma
    Clinical practice

    FDA Approves Idecabtagene Vicleucel as the First Cell-Based Gene Therapy for Adult Patients With Multiple Myeloma

    On March 27, 2021, the U.S. Food and Drug Administration (FDA) approved idecabtagene vicleucel (Abecma), for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. This is the first FDA-approved cell-based gene therapy for multiple myeloma. 

    March 30, 2021
    FDA Approves Pembrolizumab for Esophageal or GEJ Carcinoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Pembrolizumab for Esophageal or GEJ Carcinoma

    On March 22, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) for use in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (GEJ) (tumors with an epicenter 1–5 cm above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation. 

    March 23, 2021
    FDA Approves Tivozanib for Relapsed or Refractory Advanced Renal Cell Carcinoma
    Oncology drug research

    FDA Approves Tivozanib for Relapsed or Refractory Advanced Renal Cell Carcinoma

    On March 10, 2021, the U.S. Food and Drug Administration (FDA) approved tivozanib (Fotivda®), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. FDA approved the application three weeks ahead of its goal date.

    March 11, 2021
    FDA Grants Accelerated Approval to Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Axicabtagene Ciloleucel for Relapsed or Refractory Follicular Lymphoma

    On March 5, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to axicabtagene ciloleucel (Yescarta®) for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

    March 09, 2021
    FDA Approves Lorlatinib for ALK-Positive Metastatic NSCLC
    Lung Cancer

    FDA Approves Lorlatinib for ALK-Positive Metastatic NSCLC

    On March 3, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to lorlatinib (Lorbrena®) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. FDA also approved the Ventana ALK (D5F3) CDx Assay as a companion diagnostic for lorlatinib.

    March 04, 2021
    FDA Grants Accelerated Approval to Melphalan Flufenamide for Relapsed or Refractory Multiple Myeloma
    Clinical practice

    FDA Grants Accelerated Approval to Melphalan Flufenamide for Relapsed or Refractory Multiple Myeloma

    On February 26, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to melphalan flufenamide (Pepaxto®) in combination with dexamethasone for adults with relapsed or refractory multiple myeloma who received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38–directed monoclonal antibody.

    March 01, 2021
    FDA Approves Cemiplimab-Rwlc for NSCLC With High PD-L1 Expression
    Clinical practice

    FDA Approves Cemiplimab-Rwlc for NSCLC With High PD-L1 Expression

    On February 22, 2021, the U.S. Food and Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo®) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation and whose tumors have high PD-L1 expression (tumor proportion score ≥ 50%) as determined by an FDA-approved test, with no estimated aberrations to glomerular filtration rate, anaplastic lymphoma kinase, or receptor tyrosine kinase (encoded by the ROS1 gene). 

    February 23, 2021
    FDA Grants Accelerated Approval to Umbralisib for Marginal Zone and Follicular Lymphoma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Umbralisib for Marginal Zone and Follicular Lymphoma

    On February 5, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to umbralisib (Ukoniq™), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and adult patients with relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapy.

    February 08, 2021
    Oncology Drug Reference Sheet: Tafasitamab-Cxix
    Oncology drug research

    Oncology Drug Reference Sheet: Tafasitamab-Cxix

    Tafasitamab-cxix (Monjuvi®) received accelerated approval from the U.S. Food and Drug Administration in July 2020 in combination with lenalidomide for adults with relapsed or refractory diffuse large B-cell lymphoma.

    January 26, 2021
    Oncology Drug Reference Sheet: Alpelisib
    Clinical practice

    Oncology Drug Reference Sheet: Alpelisib

    When used in combination with fulvestrant, alpelisib (Piqray®) produced complete or partial responses in 29% of patients with PIK3CA-altered, estrogen receptor-positive advanced breast cancer in clinical trials. The U.S. Food and Drug Administration approved it for use in 2019.

    December 29, 2020
    Oncology Drug Reference Sheet: Selpercatinib
    Clinical practice

    Oncology Drug Reference Sheet: Selpercatinib

    In May 2020, the U.S. Food and Drug Administration gave accelerated approval for selpercatinib (Retevmo®) to treat RET-altered non-small cell lung cancer or thyroid cancer based on overall response rate and duration of response. Selpercatinib fights cancer by impeding RET protein activity. The determining clinical trial results demonstrated that it reduced tumor size in more than 50% of patients and was associated with fewer adverse reactions than other drugs that block the RET protein.

    November 24, 2020
    COVID-19 Drug Reference Sheet: Bamlanivimab
    COVID-19

    COVID-19 Drug Reference Sheet: Bamlanivimab

    On November 9, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for bamlanivimab, an unapproved agent, to treat mild to moderate cases of the COVID-19 coronavirus. EUAs are not FDA approvals; rather, they authorize use of an unapproved medication in an emergency setting. Bamlanivimab’s initial supply is limited, but the manufacturer announced increased production and distribution in early 2021.

    November 20, 2020
    FDA Grants Accelerated Approval to Pembrolizumab for Locally Recurrent Unresectable or Metastatic TNBC
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Pembrolizumab for Locally Recurrent Unresectable or Metastatic TNBC

    On November 13, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple negative breast cancer (TNBC) whose tumors express PD-L1 (combined positive score [CPS] ≥ 10) as determined by an FDA-approved test. FDA also approved the PD-L1 IHC 22C3 pharmDx as a companion diagnostic for selecting patients with TNBC for pembrolizumab.

    November 16, 2020
    Lohxa, LLC, Recalls Chlorhexidine Gluconate Oral Rinse Because of Microbial Contamination
    U.S. Food and Drug Administration (FDA)

    Lohxa, LLC, Recalls Chlorhexidine Gluconate Oral Rinse Because of Microbial Contamination

    Lohxa, LLC, issued a voluntary recall of five lots of its alcohol-free chlorhexidine gluconate oral rinse USP 0.12% because of a risk that the product may be contaminated with the bacteria Burkholderia lata. The U.S Food and Drug Administration announced the recall on November 9, 2020. 

    November 10, 2020
    Oncology Drug Reference Sheet: Lurbinectedin
    Clinical practice

    Oncology Drug Reference Sheet: Lurbinectedin

    In June 2020, the U.S. Food and Drug Administration granted accelerated approval to lurbinectedin (ZepzelcaTM) for adults with metastatic small cell lung cancer (SCLC) whose disease has progressed on or after platinum-based chemotherapy. The approval adds a second choice for patients who experience treatment-resistant SCLC progression, who previously had only topotecan as an option.

    October 20, 2020
    Oncology Drug Reference Sheet: Zanubrutinib
    Clinical practice

    Oncology Drug Reference Sheet: Zanubrutinib

    Zanubrutinib (BrukinsaTM) received U.S. Food and Drug Administration accelerated approval on November 14, 2019, for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.

    September 22, 2020
    Oncology Drug Reference Sheet: Rucaparib
    Clinical practice

    Oncology Drug Reference Sheet: Rucaparib

    Rucaparib (Rubraca®) has U.S. Food and Drug Administration approval for both maintenance and treatment indications in gynecologic cancers. It originally received accelerated approval in 2016 for the treatment of deleterious, BRCA variant–associated advanced ovarian cancer that has failed two or more chemotherapies. In 2018, it was approved for maintenance therapy of various gynecologic malignancies. Most recently, rucaparib received approval for BRCA-positive metastatic castration-resistant prostate cancer treatment after androgen-directed and chemotherapy.

    August 25, 2020
    Early Use of Immunotherapy Has Better Outcomes for Bladder Cancer
    Immunotherapy

    Early Use of Immunotherapy Has Better Outcomes for Bladder Cancer

    Starting immunotherapy for bladder cancer shortly after initial treatment with chemotherapy is better than taking an extended break from cancer treatment, according to results from a study reported at the American Society of Clinical Oncology annual meeting.

    August 12, 2020
    FDA Approves First Liquid Biopsy NGS Companion Diagnostic Test for NSCLC
    U.S. Food and Drug Administration (FDA)

    FDA Approves First Liquid Biopsy NGS Companion Diagnostic Test for NSCLC

    On August 7, 2020, the U.S. Food and Drug Administration (FDA) approved the Guardant360 CDx assay as the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations of the epidermal growth factor receptor gene in patients with metastatic non-small cell lung cancer (NSCLC). This is the first approval to combine two technologies in one diagnostic test to guide treatment decisions. 

    August 11, 2020
    FDA Grants Accelerated Approval to Belantamab Mafodotin-Blmf for Multiple Myeloma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Belantamab Mafodotin-Blmf for Multiple Myeloma

    On August 5, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to belantamab mafodotin-blmf (Blenrep) for adult patients with relapsed or refractory multiple myeloma who received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

    August 06, 2020
    FDA Grants Accelerated Approval to Tafasitamab-Cxix for Diffuse Large B-Cell Lymphoma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Tafasitamab-Cxix for Diffuse Large B-Cell Lymphoma

    On July 31, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tafasitamab-cxix (Monjuvi®), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplant.

    August 04, 2020
    FDA Approves Atezolizumab for BRAF V600 Unresectable or Metastatic Melanoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Atezolizumab for BRAF V600 Unresectable or Metastatic Melanoma

    On July 30, 2020, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq®) in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

    August 03, 2020
    Oncology Drug Reference Sheet: Enfortumab Vedotin-Ejfv
    U.S. Food and Drug Administration (FDA)

    Oncology Drug Reference Sheet: Enfortumab Vedotin-Ejfv

    Enfortumab vedotin-ejfv (Padcev™) was granted accelerated approval in December 2019 for adults with locally advanced or metastatic urothelial cancer who previously received an immune checkpoint inhibitor (PD-1 or PD-L1 inhibitor) and platinum-containing therapy.

    July 28, 2020
    FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory MCL
    U.S. Food and Drug Administration (FDA)

    FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory MCL

    On July 24, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to brexucabtagene autoleucel (Tecartus™), a CD19-directed genetically modified autologous T cell immunotherapy, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.

    July 27, 2020
    FDA Approves Oral Combination of Decitabine and Cedazuridine for Myelodysplastic Syndromes
    U.S. Food and Drug Administration (FDA)

    FDA Approves Oral Combination of Decitabine and Cedazuridine for Myelodysplastic Syndromes

    On July 7, 2020, the U.S. Food and Drug Administration (FDA) approved an oral combination of decitabine and cedazuridine (Inqovi®) for adult patients with myelodysplastic syndromes, including the following:

    July 08, 2020
    FDA Approves Avelumab for Urothelial Carcinoma Maintenance Treatment
    Oncology drug research

    FDA Approves Avelumab for Urothelial Carcinoma Maintenance Treatment

    On June 30, 2020, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio®) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

    July 02, 2020
    Antibody-Drug Conjugates Join the Best of Two Worlds Into One New Treatment
    Cancer research

    Antibody-Drug Conjugates Join the Best of Two Worlds Into One New Treatment

    A new class of drugs, antibody-drug conjugates (ADCs), combines the specificity of targeted therapy with the cytotoxicity of chemotherapy for a powerhouse effect against certain types of cancer variants. Here’s what you need to know about this novel treatment modality.

    July 01, 2020
    FDA Approves Pembrolizumab for First-Line Treatment of MSI-H/dMMR Colorectal Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Pembrolizumab for First-Line Treatment of MSI-H/dMMR Colorectal Cancer

    On June 29, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) for first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

    June 30, 2020
    FDA Approves Combination of Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf for HER2-Positive Breast Cancer
    Oncology drug research

    FDA Approves Combination of Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf for HER2-Positive Breast Cancer

    On June 29, 2020, the U.S. Food and Drug Administration (FDA) approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo™) via subcutaneous injection for use in combination with docetaxel to treat patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

    June 30, 2020
    FDA Approves Pembrolizumab for Treatment of Cutaneous Squamous Cell Carcinoma
    Oncology drug research

    FDA Approves Pembrolizumab for Treatment of Cutaneous Squamous Cell Carcinoma

    On June 24, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable with surgery or radiation.

    June 25, 2020
    FDA Approves Selinexor for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
    Oncology drug research

    FDA Approves Selinexor for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

    On June 22, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selinexor (Xpovio®) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.

    June 23, 2020
    HIV-Positive Patients With Cancer Need to Be Included in Clinical Drug Trials
    U.S. Food and Drug Administration (FDA)

    HIV-Positive Patients With Cancer Need to Be Included in Clinical Drug Trials

    Viral infections such as HIV may increase a person’s risk for developing several malignancies. However, most investigational drug studies exclude HIV-positive patients with cancer and optimal treatment regimens remain unknown.

    June 23, 2020
    FDA Grants Accelerated Approval to Tazemetostat for Follicular Lymphoma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Tazemetostat for Follicular Lymphoma

    On June 18, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik™), an EZH2 inhibitor, for adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation, as detected by an FDA-approved test, who have received at least two prior systemic therapies and have no satisfactory alternative treatment options.

    June 19, 2020
    FDA Approves Pembrolizumab for Patients With TMB-H Solid Tumors
    U.S. Food and Drug Administration (FDA)

    FDA Approves Pembrolizumab for Patients With TMB-H Solid Tumors

    On June 16, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda®) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥ 10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and have no satisfactory alternative treatment options.

    June 17, 2020
    FDA Extends Indication for Gemtuzumab Ozogamicin for CD33-Positive AML in Pediatric Patients
    U.S. Food and Drug Administration (FDA)

    FDA Extends Indication for Gemtuzumab Ozogamicin for CD33-Positive AML in Pediatric Patients

    On June 16, 2020, the U.S. Food and Drug Administration (FDA) extended the indication of gemtuzumab ozogamicin (Mylotarg™) for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients aged 1 month and older.

    June 16, 2020
    FDA Grants Accelerated Approval to Lurbinectedin for Metastatic Small Cell Lung Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Lurbinectedin for Metastatic Small Cell Lung Cancer

    On June 15, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lurbinectedin (Zepzelca™) for adult patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy.

    June 16, 2020
    FDA Approves Ramucirumab Plus Erlotinib for First-Line Treatment of Metastatic NSCLC
    Oncology drug research

    FDA Approves Ramucirumab Plus Erlotinib for First-Line Treatment of Metastatic NSCLC

    On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved ramucirumab (Cyramza®) in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 mutations. 

    June 01, 2020
    FDA Approves Nivolumab Plus Ipilimumab and Chemotherapy for First-Line Treatment of Metastatic NSCLC
    Oncology drug research

    FDA Approves Nivolumab Plus Ipilimumab and Chemotherapy for First-Line Treatment of Metastatic NSCLC

    On May 26, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab plus ipilimumab  and two cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.

    May 27, 2020
    FDA Approves Brigatinib for ALK-Positive, Metastatic NSCLC
    U.S. Food and Drug Administration (FDA)

    FDA Approves Brigatinib for ALK-Positive, Metastatic NSCLC

    On May 22, 2020, the U.S. Food and Drug Administration (FDA) approved brigatinib (Alunbrig®) for adult patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC). FDA also approved the Vysis ALK Break Apart FISH Probe Kit as a companion diagnostic for brigatinib. 

    May 26, 2020
    Oncology Drug Reference Sheet: Capecitabine
    Prescription medication

    Oncology Drug Reference Sheet: Capecitabine

    Capecitabine (Xeloda®) was approved by the U.S. Food and Drug Administration (FDA) in 1998 as a nucleoside metabolic inhibitor with antineoplastic activity indicated for adjuvant colon cancer, metastatic colorectal cancer, and metastatic breast cancer.

    May 26, 2020
    FDA Approves Olaparib for HRR Gene-Mutated, Metastatic, Castration-Resistant Prostate Cancer
    Oncology drug research

    FDA Approves Olaparib for HRR Gene-Mutated, Metastatic, Castration-Resistant Prostate Cancer

    On May 19, 2020, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza®) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated, metastatic, castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone.

    May 20, 2020
    FDA Approves Atezolizumab for First-Line Treatment of Metastatic NSCLC With High PD-L1 Expression
    U.S. Food and Drug Administration (FDA)

    FDA Approves Atezolizumab for First-Line Treatment of Metastatic NSCLC With High PD-L1 Expression

    On May 18, 2020, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq®) for first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 staining ≥ 50% of tumor cells [TC] or PD-L1-stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area), with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations. 

    May 19, 2020
    FDA Approves Ripretinib for Advanced Gastrointestinal Stromal Tumor
    U.S. Food and Drug Administration (FDA)

    FDA Approves Ripretinib for Advanced Gastrointestinal Stromal Tumor

    On May 15, 2020, the U.S. Food and Drug Administration (FDA) approved ripretinib (Qinlock™) for adult patients with advanced gastrointestinal stromal tumors (GISTs) who received prior treatment with three or more kinase inhibitors, including imatinib. 

    May 18, 2020
    FDA Grants Accelerated Approval to Rucaparib for BRCA-Mutated, Metastatic, Castration-Resistant Prostate Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Rucaparib for BRCA-Mutated, Metastatic, Castration-Resistant Prostate Cancer

    On May 15, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to rucaparib (Rubraca®) for patients with deleterious BRCA mutation (germline or somatic)-associated, metastatic, castration-resistant prostate cancer (mCRPC) who had been treated with androgen receptor-directed therapy and taxane-based chemotherapy. 

    May 18, 2020
    FDA Approves Nivolumab Plus Ipilimumab for First-Line Metastatic Non-Small Cell Lung Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Nivolumab Plus Ipilimumab for First-Line Metastatic Non-Small Cell Lung Cancer

    On May 15, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo®) and ipilimumab (Yervoy®) as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥ 1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. 

    May 18, 2020
    FDA Grants Accelerated Approval to Pomalidomide for Kaposi Sarcoma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Pomalidomide for Kaposi Sarcoma

    On May 14, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of pomalidomide (Pomalyst®) to include treating adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy and Kaposi sarcoma in adult patients who are HIV negative. 

    May 15, 2020
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