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    ONS Members Tell Us About the Inspirational Nurses Who’ve Shaped Their Careers
    Nurse well-being
    ONS Members Tell Us About the Inspirational Nurses Who’ve Shaped Their Careers
    November 23, 2023
    Nurse Educator–Led Educational Fairs Help Reduce Hospital-Acquired Conditions
    Oncology nurse education
    Nurse Educator–Led Educational Fairs Help Reduce Hospital-Acquired Conditions
    November 10, 2023
    When the Nurse Coach Becomes the Client: How I Restored Balance and Set Goals on a Healing Journey
    Oncology nurse influence
    When the Nurse Coach Becomes the Client: How I Restored Balance and Set Goals on a Healing Journey
    November 03, 2023
    Filipino American History Month nurse standing next to flag
    Nurse empowerment
    Filipino American History Month Shines Light on the Contributions and Challenges of a Committed Community of Nurses
    October 16, 2023
    Explore Somatic Biomarker Testing Report Component Biomarker Testing
    Clinical practice
    Learn How to Read a Somatic Biomarker Testing Report
    October 06, 2023
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    U.S. Food and Drug Administration (FDA)

    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Approves Nirogacestat as the First Treatment for Desmoid Tumors

    On November 27, 2023, the U.S. Food and Drug Administration (FDA) approved nirogacestat (Ogsiveo™) for use in adult patients with progressing desmoid tumors who require systemic treatment. Nirogacestat is the first approved treatment for desmoid tumors.

    November 28, 2023
    Oncology Drug Reference Sheet: Glofitamab-Gxbm
    U.S. Food and Drug Administration (FDA)

    Oncology Drug Reference Sheet: Glofitamab-Gxbm

    After an open-label, multicenter, single-arm trial demonstrated a 56% objective response rate, with 43% achieving complete responses, and an estimated 18.4-month median duration of response, the U.S. Food and Drug Administration granted glofitamab-gxbm (Columvi™) accelerated approval in June 2023. 

    November 28, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Announces Bayer’s Voluntary Nationwide Recall of Larotrectinib Oral Solution 20 mg/ml

    On November 21, 2023, the U.S. Food and Drug Administration (FDA) advised that Bayer issued a voluntary recall for one lot of larotrectinib (Vitrakvi®) oral solution 20 mg/ml in 100 ml glass bottles to the user level because of Penicillium brevicompactum microbial contamination observed during routine stability testing.

    November 22, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Warns Not to Use Cardinal Health Monoject Syringes With Syringe Pumps and PCA Pumps

    On November 20, 2023, the U.S. Food and Drug Administration (FDA) alerted healthcare providers and facilities not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps while the agency further evaluates a reported issue. FDA classified it as a class I recall, the most serious type of recall, where use of the product or device may result in serious injury or death.

    November 21, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Announces B. Braun Medical, Inc.’s, Recall of Infusomat Space Large Volume Wireless and Non-Wireless Pumps

    On November 17, 2023, the U.S. Food and Drug Administration (FDA) announced that B. Braun Medical, Inc., is recalling its Infusomat Space Volumetric Infusion Pump System because of faulty occlusion alarms, causing the pump to stop delivering medications, including high-risk medications such as vasopressors. Interrupting the infusion of high-risk medications may lead to hemodynamic instability, which may be life-threatening or lead to death in some cases. FDA is aware of 51 reports, one injury, and one death related to the recall. The agency has identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.

    November 20, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Approves Enzalutamide for Nonmetastatic Castration-Sensitive Prostate Cancer With Biochemical Recurrence

    On November 16, 2023, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi®) for non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

    November 17, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Approves Pembrolizumab With Chemotherapy for HER2-Negative Gastric or Gastroesophageal Junction Adenocarcinoma

    On November 16, 2023, the U.S Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) with fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.

    November 16, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Approves Capivasertib With Fulvestrant for Breast Cancer

    On November 16, 2023, the U.S. Food and Drug Administration (FDA) approved capivasertib (Truqap™) with fulvestrant for adult patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. FDA also approved the FoundationOne®CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with capivasertib with fulvestrant.

    November 16, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Approves Repotrectinib for ROS1-Positive Non-Small Cell Lung Cancer

    On November 15, 2023, the U.S. Food and Drug Administration (FDA) approved repotrectinib (Augtyro™) for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). This is the first FDA approval for treatment of patients with ROS1-positive NSCLC who have previously received a ROS1 tyrosine kinase inhibitor (TKI), in addition to patients who are TKI naïve.

    November 15, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Reports Fresenius Medical Care’s Recall of Sanxin Single-Use Syringes

    On November 15, 2023, the U.S. Food and Drug Administration (FDA) reported that Fresenius Medical Care is recalling three types of its Sanxin single-use syringes because of leakages. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.

    November 15, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Amends Pembrolizumab’s Gastric Cancer Indication

    On November 7, 2023, the U.S. Food and Drug Administration (FDA) revised the existing indication of pembrolizumab (Keytruda®) with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. This updated indication, which remains approved under accelerated approval regulations, restricts its use to patients whose tumors express PD-L1 (CPS ≥ 1), as determined by an FDA-approved test.

    November 09, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Approves Fruquintinib in Refractory Metastatic Colorectal Cancer

    On November 8, 2023, the U.S. Food and Drug Administration (FDA) approved fruquintinib (Fruzaqla™) for adult patients with metastatic colorectal cancer who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

    November 09, 2023
    FDA update
    Safety

    FDA Announces Teleflex and Arrow International’s Recall of Mislabeled Pressure Injectable Catheter Kits

    On November 6, 2023, the U.S. Food and Drug Administration (FDA) announced that Teleflex, and its subsidiary Arrow International, are recalling 1,905 pressure injectable central venous catheter kits due to mislabeling regarding the presence of chlorhexidine in these products. FDA has identified it as a class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

    November 09, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    Do Not Use Certain Brands of Saline and Sterile Water Medical Products From Nurse Assist Because They May Not Be Sterile, FDA Warns

    On November 6, 2023, the U.S. Food and Drug Administration (FDA) announced Nurse Assist, LLC’s, recall and warned consumers, healthcare providers, and healthcare facilities not to use recalled saline (0.9% sodium chloride) and sterile water medical products manufactured by Nurse Assist, LLC, and sold under various brands, because they may not be sterile.

    November 06, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Approves Pembrolizumab With Chemotherapy for Biliary Tract Cancer

    On October 31, 2023, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) used with gemcitabine and cisplatin for the treatment of locally advanced unresectable or metastatic biliary tract cancer.

    November 01, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Approves Toripalimab-Tpzi for Nasopharyngeal Carcinoma

    On October 27, 2023, the U.S. Food and Drug Administration (FDA) approved toripalimab-tpzi (Loqtorz) with cisplatin and gemcitabine for first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.

    October 31, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Announces Exela’s Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 ml, Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 ml, and Cysteine Hydrochloride Injection, USP 500 mg/10 ml

    On October 25, 2023, the U.S. Food and Drug Administration (FDA) announced that Exela Pharma Sciences, LLC (Exela), is voluntarily recalling the following products to the consumer level because it observed silicone particulate matter during routine inspection of retained samples.

    October 29, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Approves Ivosidenib for Myelodysplastic Syndrome

    On October 24, 2023, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo®) for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) variant, as detected by an FDA-approved test. The agency also approved the Abbott RealTime IDH1 assay as a companion diagnostic device to select patients for ivosidenib treatment.

    October 24, 2023
    Oncology Drug Reference Sheet: Mirvetuximab Soravtansine-Gynx
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Mirvetuximab Soravtansine-Gynx

    After a single-arm clinical trial demonstrated an overall response rate of 31.7% in 106 patients with folate receptor (FR) alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, the U.S. Food and Drug Administration granted mirvetuximab soravtansine-gynx (Elahere™) accelerated approval on November 14, 2022.  

    October 24, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Expands Pediatric Indication for Entrectinib and Approves New Pellet Formulation

    On October 20, 2023, the U.S Food and Drug Administration (FDA) granted accelerated approval to entrectinib (Rozlytrek®) for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance variant, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. In August 2019, FDA granted entrectinib accelerated approval for pediatric patients aged 12 years or older for the indication.

    October 20, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Approves Neoadjuvant and Adjuvant Pembrolizumab for Resectable NSCLC

    On October 16, 2023, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda®) with platinum-containing chemotherapy as neoadjuvant treatment and with continuation of single-agent pembrolizumab as postsurgical adjuvant treatment for resectable (tumors ≥ 4 cm or node positive) non-small cell lung cancer (NSCLC).

    October 17, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Approves Nivolumab for Adjuvant Treatment of Stage IIB/C Melanoma

    On October 13, 2023, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo®) for the adjuvant treatment of completely resected stage IIB/C melanoma in patients aged 12 years and older.

    October 16, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Approves Encorafenib With Binimetinib for Metastatic NSCLC With a BRAF V600E Variant

    On October 11, 2023, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi®) with binimetinib (Mektovi®) for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E variant, as detected by an FDA-approved test.

    October 12, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    Hospira, Inc., Issues a Voluntary Nationwide Recall for 4.2% Sodium Bicarbonate, 1% and 2% Lidocaine HCl Injections, USP

    On October 2, 2023, the U.S. Food and Drug Administration reported Hospira, Inc.’s, voluntary recall of several lots of 4.2% sodium bicarbonate injection, USP, 5 mEq/10 ml vial; 1% lidocaine HCl injection, USP, 50 mg/5 ml vial; and 2% lidocaine HCl injection, USP, 100 mg/5 ml vial to the user level because of the potential for presence of glass particulate matter.

    October 05, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Safety Communication Provides Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks

    On September 29, 2023, the U.S. Food and Drug Administration (FDA) issued an updated safety communication to consumers, healthcare providers, and facilities about certain surgical N95 respirators and masks manufactured by Owens and Minor (O&M) Halyard. FDA updated its recommendations for the products based on new data and information from O&M Halyard.  

    October 02, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Approves Bosutinib for Pediatric Patients With Chronic Myelogenous Leukemia

    On September 26, 2023, the U.S. Food and Drug Administration (FDA) approved bosutinib (Bosulif®) for pediatric patients aged 1 year and older with chronic phase Ph+ chronic myelogenous leukemia that is newly diagnosed or resistant or intolerant to prior therapy. FDA also approved a new 50 mg and 100 mg capsule dosage form.

    September 27, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1 g/10 ml

    September 27, 2023
    Oncology Drug Reference Sheet: Capmatinib
    Oncology drug research

    Oncology Drug Reference Sheet: Capmatinib

    In August 2022, the U.S. Food and Drug Administration granted regular approval to capmatinib (Tabrecta®) for adults with metastatic non-small cell lung cancer whose tumors have a variant that leads to mesenchymal-epithelial transition exon 14 skipping. Capmatinib was granted accelerated approval for the same indication in May 2020; the regular approval in August 2022 was based on additional data from 63 patients and follow-up data establishing durability of response and clinical benefit.

    September 26, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    Medline Industries Recalls One Lot of Hudson RCI AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution

    On September 20, 2023, the U.S. Food and Drug Administration (FDA) announced that Medline Industries had recalled a single lot of Hudson RCI AddiPak® unit dose vial, 0.9% full normal saline solution, because it may be nonsterile. FDA identified it as a class I recall, the most serious type of recall, where usage may cause serious injuries or death.

    September 25, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    FDA Approves New and Updated Indications for Temozolomide Under Project Renewal

    On September 14, 2023, the U.S. Food and Drug Administration (FDA) approved new labeling for temozolomide (Temodar®) under Project Renewal, an Oncology Center of Excellence (OCE) initiative that updates labeling information for older oncology drugs to ensure it is clinically meaningful and scientifically current. This is the second drug—both anticancer agents—to receive a labeling update under the pilot program. The first was for capecitabine (Xeloda®).

    September 15, 2023
    FDA update
    U.S. Food and Drug Administration (FDA)

    Novartis Issues Voluntary Nationwide Recall of One Lot of Cyclosporine Oral Solution

    On September 11, 2023, the U.S. Food and Drug Administration announced Novartis’s voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/ml, in the United States because of observations of crystals in some bottles that could result in incorrect dosing. No other cyclosporine oral solution formulations are affected.

    September 13, 2023
    U.S. Congress Members Call for Overdue Review, Enforcement of E-Cigarettes Still on Market
    Health Policy

    U.S. Congress Members Call for Overdue Review, Enforcement of E-Cigarettes Still on Market

    U.S. Representatives Diana DeGette (D-CO) and Debbie Wasserman Schultz (D-FL), along with more than 50 members of the U.S. Congress, wrote a letter in June 2023 calling on the U.S. Food and Drug Administration (FDA) to abide by a court-ordered deadline to review outstanding Premarket Tobacco Product Applications for e-cigarette products that remain on the market without approval. The call comes after FDA failed to meet the initial deadline of September 9, 2021, to complete its review of all pending e-cigarette applications.

    August 23, 2023
    COVID-19 Pandemic and the Supply Chain Among Reasons for the 2022 Drug Shortages, FDA Says
    U.S. Food and Drug Administration (FDA)

    COVID-19 Pandemic and the Supply Chain Among Reasons for the 2022 Drug Shortages, FDA Says

    In its annual report to the U.S. Congress on drug shortages, the U.S. Food and Drug Administration cited the COVID-19 pandemic, supply chain problems, and approval processes as reasons for the shortages during the 2022 calendar year.

    August 22, 2023
    FDA Taking Action on Youth E-Cigarettes Usage with Warning Letters to Retailers
    U.S. Food and Drug Administration (FDA)

    FDA Takes Action on Youth E-Cigarette Usage With Warning Letters to Retailers

    In a record number of outreaches, the U.S. Food and Drug Administration issued warning letters in June 2023 to 189 retailers for selling unauthorized tobacco products. Two notable brands included in the warning, Elf Bar and Esco Bars, sell disposable e-cigarettes that come in flavors that appeal to youth, such as bubblegum and cotton candy.

    August 21, 2023
    FDA Approves Melphalan as a Liver-Directed Treatment for Uveal Melanoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Melphalan as a Liver-Directed Treatment for Uveal Melanoma

    On August 14, 2023, the U.S. Food and Drug Administration approved melphalan (Hepzato™) for injection or hepatic delivery system (Hepzato Kit) containing melphalan as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

    August 16, 2023
    FDA Grants Accelerated Approval to Elranatamab-Bcmm for Multiple Myeloma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Elranatamab-Bcmm for Multiple Myeloma

    On August 14, 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to elranatamab-bcmm (Elrexfio™), a bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

    August 15, 2023
    FDA Approves Niraparib and Abiraterone Acetate Plus Prednisone for BRCA-Variant Metastatic Castration-Resistant Prostate Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Niraparib and Abiraterone Acetate Plus Prednisone for BRCA-Variant Metastatic Castration-Resistant Prostate Cancer

    On August 11, 2023, the U.S. Food and Drug Administration (FDA) approved the fixed dose combination of niraparib and abiraterone acetate (Akeega™) plus prednisone for adult patients with deleterious or suspected deleterious BRCA variant metastatic castration-resistant prostate cancer, as determined by an FDA-approved test.

    August 14, 2023
    FDA Grants Accelerated Approval to Talquetamab-Tgvs for Relapsed or Refractory Multiple Myeloma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Talquetamab-Tgvs for Relapsed or Refractory Multiple Myeloma

    On August 9, 2023, the U.S. Food and Drug Administration granted accelerated approval to talquetamab-tgvs (Talvey™) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

    August 11, 2023
    FDA Approves Pralsetinib for Non-Small Cell Lung Cancer With RET Gene Fusions
    U.S. Food and Drug Administration (FDA)

    FDA Approves Pralsetinib for Non-Small Cell Lung Cancer With RET Gene Fusions

    On August 9, 2023, the U.S. Food and Drug Administration (FDA) granted regular approval to pralsetinib (Gavreto®) for adult patients with metastatic, rearranged during transfection fusion-positive non-small cell lung cancer as detected by an FDA-approved test.

    August 10, 2023
    FDA Approves Trifluridine and Tipiracil With Bevacizumab for Previously Treated Metastatic Colorectal Cancer
    Oncology drug research

    FDA Approves Trifluridine and Tipiracil With Bevacizumab for Previously Treated Metastatic Colorectal Cancer

    On August 2, 2023, the U.S. Food and Drug Administration (FDA) approved trifluridine and tipiracil (Lonsurf®) with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biologic therapy, and if RAS wild-type, an anti-EGFR therapy. FDA had previously approved single-agent trifluridine and tipiracil for the indication in September 2015.

    August 03, 2023
    Baxter Healthcare Corporation Recalls SIGMA Spectrum Infusion Pumps and IQ Infusion Systems With Dose IQ Safety Software, Issues Corrected Software
    U.S. Food and Drug Administration (FDA)

    Baxter Healthcare Corporation Recalls SIGMA Spectrum Infusion Pumps and IQ Infusion Systems With Dose IQ Safety Software, Issues Corrected Software

    On August 1, 2023, the U.S. Food and Drug Administration (FDA) reported Baxter Healthcare Corporation’s June 15, 2023, recall of SIGMA Spectrum infusion pumps with master drug library (version 8) and Spectrum IQ infusion systems with dose IQ safety software (version 9) because of false alarms for upstream occlusion after pump software upgrades to version v8.01.01 and v9.02.01, respectively. FDA identified it as a class I recall, the most serious type of recall, where use of the devices may cause serious injuries or death.

    August 02, 2023
    FDA approves Dostarlimab-Gxly With Chemotherapy for Endometrial Cancer
    Oncology drug research

    FDA Approves Dostarlimab-Gxly With Chemotherapy for Endometrial Cancer

    On July 31, 2023, the U.S. Food and Drug Administration approved dostarlimab-gxly (Jemperli) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer that is mismatch repair deficient, as determined by an FDA-approved test, or microsatellite instability-high.

    August 01, 2023
    Oncology Drug Reference Sheet: Adagrasib
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Adagrasib

    After clinical trials demonstrated a 43% durable objective response rate with a median 8.5-month duration, the U.S. Food and Drug Administration (FDA) granted adagrasib (Krazati™) accelerated approval in December 2022 for adult patients with locally advanced or metastatic non-small cell lung cancer with a KRAS G12C variant, as detected by an FDA-approved test, whose disease has progressed on or after at least one prior systemic therapy.

    July 25, 2023
    FDA Approves Quizartinib for Newly Diagnosed Acute Myeloid Leukemia
    U.S. Food and Drug Administration (FDA)

    FDA Approves Quizartinib for Newly Diagnosed Acute Myeloid Leukemia

    On July 20, 2023, the U.S. Food and Drug Administration (FDA) approved quizartinib (Vanflyta®) in combination with standard cytarabine and anthracycline induction and cytarabine consolidation and as maintenance monotherapy following consolidation chemotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukemia that are FLT3 internal tandem duplication-positive, as detected by an FDA-approved test. FDA also approved the LeukoStrat CDx FLT3 variant assay as a companion diagnostic for quizartinib.

    July 21, 2023
    Oncology Drug Reference Sheet: Elacestrant
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Elacestrant

    After clinical trial outcomes demonstrated a statistically significant difference in progression-free survival in a subgroup of patients with estrogen receptor-positive, HER2-negative, ESR1-altered disease, the U.S. Food and Drug Administration granted elacestrant’s (Orserdu™) application priority review and fast-track designation, with regular approval in January 2023.   

    July 06, 2023
    A Decade of Research Reminds Advocates That Awareness Is the First Step for Tobacco Reduction
    Patient safety

    A Decade of Research Reminds Advocates That Awareness Is the First Step for Tobacco Reduction

    Ushering in a new field of study called tobacco regulatory research, the U.S. Food and Drug Administration’s Tobacco Regulatory Science Program (TRSP) funded its first 14 Tobacco Centers of Regulatory Science in 2013. Ten years later, David M. Murray, PhD, associate director of the National Institutes of Health’s Office of Disease Prevention, highlighted TRSP’s decade of research discoveries—but reinforced the need for continued research and advocacy on tobacco use.

    June 29, 2023
    Oncology Drug Reference Sheet: Teclistamab-Cqyv
    Oncology drug research

    Oncology Drug Reference Sheet: Teclistamab-Cqyv

    With an estimated duration of response rate of 90.6% at six months and 66.5% at nine months in the agent’s clinical trials, in October 2022, the U.S. Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli™) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four previous lines of therapy.  

    June 27, 2023
    FDA Approves Talazoparib With Enzalutamide for HRR Gene–Variant Metastatic Castration-Resistant Prostate Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Talazoparib With Enzalutamide for HRR Gene–Variant Metastatic Castration-Resistant Prostate Cancer

    On June 20, 2023, the U.S. Food and Drug Administration approved talazoparib (Talzenna®) with enzalutamide for homologous recombination repair gene–variant metastatic, castration-resistant prostate cancer.

    June 21, 2023
    FDA Grants Accelerated Approval to Glofitamab-Gxbm for Selected Relapsed or Refractory Large B-Cell Lymphomas
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Glofitamab-Gxbm for Selected Relapsed or Refractory Large B-Cell Lymphomas

    On June 15, 2023, the U.S. Food and Drug Administration granted accelerated approval to glofitamab-gxbm (Columvi™) for relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy.

    June 19, 2023
    The Harvard Drug Group, LLC, Issues Voluntary Nationwide Recall of Dronabinol Capsules, USP, 2.5 mg, and Ziprasidone Hydrochloride Capsules, 20 mg, Because of Label Mix-Up
    U.S. Food and Drug Administration (FDA)

    The Harvard Drug Group, LLC, Issues Voluntary Nationwide Recall of Dronabinol Capsules, USP, 2.5 mg, and Ziprasidone Hydrochloride Capsules, 20 mg, Because of Label Mix-Up

    On June 14, 2023, the U.S. Food and Drug Administration reported that the Harvard Drug Group, LLC, conducting business as Major Pharmaceuticals and Rugby Laboratories, issued a voluntary recall of a single lot of dronabinol capsules, USP, 2.5 mg, and ziprasidone hydrochloride capsules, 20 mg, after receiving a report that some unit dose cartons labeled as ziprasidone hydrochloride capsules, 20 mg, contained blister packages labeled as and containing dronabinol capsules, USP, 2.5 mg.

    June 16, 2023
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