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    Clinical and Pharmaceutical Nurse Educators Collaborate to Bring Training to Nurses and Improve Patient Care
    Oncology nurse education
    Clinical and Pharmaceutical Nurse Educators Collaborate to Bring Training to Nurses and Improve Patient Care
    January 13, 2023
    Oncology Nurse Uses Retirement to Help Patients and Healthcare Professionals Understand Pancreatic Cancer Biomarker Testing Results
    Pancreatic cancer
    Oncology Nurse Uses Retirement to Help Patients and Healthcare Professionals Understand Pancreatic Cancer Biomarker Testing Results
    November 11, 2022
    The Life of Marie Curie and Her Contributions to Oncology
    Cancer treatments
    The Life of Marie Curie and Her Contributions to Oncology
    November 07, 2022
    Post-Flooding Natural Disaster Cancer Considerations and Patient Education Points
    Patient safety
    Post-Flooding Natural Disaster Cancer Considerations and Patient Education Points
    September 28, 2022
    Can Patients Use Continuous Glucose Monitors During Radiation Therapy for Cancer?
    Radiation therapy
    Can Patients Use Continuous Glucose Monitors During Radiation Therapy for Cancer?
    August 19, 2022
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    Oncology drug research

    Oncology Drug Reference Sheet: Darolutamide
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Darolutamide

    On August 5, 2022, the U.S. Food and Drug Administration approved darolutamide (Nubeqa®) in combination with docetaxel in adults with metastatic hormone-sensitive prostate cancer.

    January 26, 2023
    FDA Approves Zanubrutinib for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Zanubrutinib for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

    On January 19, 2023, the U.S. Food and Drug Administration approved zanubrutinib (Brukinsa®) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

    January 20, 2023
    FDA Grants Accelerated Approval to Tucatinib With Trastuzumab for Colorectal Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Tucatinib With Trastuzumab for Colorectal Cancer

    On January 19, 2023, the U.S. Food and Drug Administration granted accelerated approval to tucatinib (Tukysa®) in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

    January 20, 2023
    FDA Grants Accelerated Approval to Mosunetuzumab-Axgb for Relapsed or Refractory Follicular Lymphoma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Mosunetuzumab-Axgb for Relapsed or Refractory Follicular Lymphoma

    On December 22, 2022, the U.S. Food and Drug Administration granted accelerated approval to mosunetuzumab-axgb (Lunsumio®), a bispecific, CD20-directed, CD3 T-cell engager for adult patients with relapsed or refractory follicular lymphoma who’ve received two or more lines of systemic therapy.

    January 06, 2023
    FDA Approves First Adenoviral Vector-Based Gene Therapy for High-Risk, BCG Unresponsive, Non–Muscle-Invasive Bladder Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves First Adenoviral Vector-Based Gene Therapy for High-Risk, BCG Unresponsive, Non–Muscle-Invasive Bladder Cancer

    On December 16, 2022, the U.S. Food and Drug Administration approved nadofaragene firadenovec-vncg (Adstiladrin®) for adult patients with high-risk, Bacillus Calmette-Guérin unresponsive, carcinoma in situ, non–muscle-invasive bladder cancer with or without papillary tumors.

    December 22, 2022
    Oncology Drug Reference Sheet: Dostarlimab-Gxly
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Dostarlimab-Gxly

    More than 40% of adult patients with mismatch repair deficient recurrent or advanced endometrial cancer had an overall response receiving dostarlimab-gxly (Jemperli), and more than 90% of those lasted six months or longer during the drug’s clinical trials. Those results led the U.S. Food and Drug Administration to grant the agent its original accelerated approval in 2021 for the indication. FDA expanded the accelerated approval later that year to include all recurrent or advanced solid tumors with dMMR demonstrated through an FDA-approved diagnostic test.

    December 20, 2022
    FDA Grants Accelerated Approval to Adagrasib for KRAS G12C–Variant Non-Small Cell Lung Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Adagrasib for KRAS G12C–Variant Non-Small Cell Lung Cancer

    On December 12, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to adagrasib (Krazati®), a RAS GTPase family inhibitor, for adult patients with KRAS G12C–variant locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, and who have received at least one prior systemic therapy.

    December 14, 2022
    FDA Approves Atezolizumab for Alveolar Soft Part Sarcoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Atezolizumab for Alveolar Soft Part Sarcoma

    On December 9, 2022, the U.S. Food and Drug Administration approved atezolizumab (Tecentriq®) for adult and pediatric patients aged 2 years and older with unresectable or metastatic alveolar soft part sarcoma.

     

    December 13, 2022
    FDA Approves Olutasidenib for Relapsed or Refractory Acute Myeloid Leukemia With Susceptible IDH1 Variants
    U.S. Food and Drug Administration (FDA)

    FDA Approves Olutasidenib for Relapsed or Refractory Acute Myeloid Leukemia With Susceptible IDH1 Variants

    On December 1, 2022, the U.S. Food and Drug Administration approved olutasidenib (Rezlidhia®) capsules for adult patients with relapsed or refractory acute myeloid leukemia with susceptible IDH1 variants as detected by an FDA-approved test. FDA also approved the Abbott RealTime IDH1 Assay to identify patients who are appropriate for olutasidenib.

    December 05, 2022
    FDA Approves Second Dosing Regimen for Asparaginase Erwinia Chrysanthemi (Recombinant)-Rywn
    U.S. Food and Drug Administration (FDA)

    FDA Approves Second Dosing Regimen for Asparaginase Erwinia Chrysanthemi (Recombinant)-Rywn

    On November 18, 2022, the U.S. Food and Drug Administration approved a Monday-Wednesday-Friday dosing option for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze®). Under the alternative regimen, patients receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings and 50 mg/m2 intramuscularly on Friday afternoons. It also is approved at a dose of 25 mg/m2 intramuscularly every 48 hours.

    November 22, 2022
    FDA Approves Brentuximab Vedotin in Combination With Chemotherapy for Pediatric Patients With Classical Hodgkin Lymphoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Brentuximab Vedotin in Combination With Chemotherapy for Pediatric Patients With Classical Hodgkin Lymphoma

    On November 10, 2022, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris®) plus doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients aged two years and older with previously untreated, high-risk classical Hodgkin lymphoma. This is the first pediatric approval for brentuximab vedotin.

    November 16, 2022
    FDA Grants Accelerated Approval to Mirvetuximab Soravtansine-Gynx for FR Alpha–Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Mirvetuximab Soravtansine-Gynx for FR Alpha–Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

    On November 14, 2022, the U.S. Food and Drug Administration granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere®) for adult patients with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, as detected with an FDA-approved test, who received one to three prior systemic treatment regimens. Mirvetuximab soravtansine-gynx is a FR alpha–directed antibody and microtubule inhibitor conjugate. FDA also approved the VENTANA FOLR1 (FOLR-2.1) RxDx Assay (Ventana Medical Systems, Inc.) as a companion diagnostic device to identify patients for the indication.

    November 16, 2022
    FDA Approves Tremelimumab in Combination With Durvalumab and Platinum-Based Chemotherapy for Metastatic Non-Small Cell Lung Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Tremelimumab in Combination With Durvalumab and Platinum-Based Chemotherapy for Metastatic Non-Small Cell Lung Cancer

    On November 10, 2022, the U.S. Food and Drug Administration approved tremelimumab (Imjudo®) in combination with durvalumab (Imfinzi®) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer with no sensitizing epidermal growth factor receptor (EGFR) variant or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.

    November 11, 2022
    FDA Approves Teclistamab-Cqyv for Relapsed or Refractory Multiple Myeloma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Teclistamab-Cqyv for Relapsed or Refractory Multiple Myeloma

    On October 25, 2022, the U.S. Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli®), the first bispecific B-cell maturation antigen–directed CD3 T-cell engager, for adult patients 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.

     

    October 26, 2022
    FDA Approves Tremelimumab in Combination With Durvalumab for Unresectable Hepatocellular Carcinoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Tremelimumab in Combination With Durvalumab for Unresectable Hepatocellular Carcinoma

    On October 21, 2022, the U.S. Food and Drug Administration approved tremelimumab (Imjudo®) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma.

    October 25, 2022
    Oncology Drug Reference Sheet: Asparaginase Erwinia Chrysanthemi (Recombinant)–Rywn
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Asparaginase Erwinia Chrysanthemi (Recombinant)–Rywn

    After more than 93% of patients maintained nadir serum asparaginase activity in the therapy’s clinical trials, on June 30, 2021, the U.S. Food and Drug Administration approved asparaginase erwinia chrysanthemi (recombinant)–rywn (RylazeTM) for use as a component of a multiagent chemotherapeutic regimen for treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who have developed hypersensitivity to E. coli-derived asparaginase.

    October 25, 2022
    FDA Grants Accelerated Approval to Futibatinib for Cholangiocarcinoma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Futibatinib for Cholangiocarcinoma

    On September 30, 2022, the U.S. Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi®) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements.

    October 03, 2022
    Oncology Drug Reference Sheet: Selinexor
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Selinexor

    After clinical trials demonstrated a 25% response rate in patients with multiple myeloma, selinexor (Xpovio®) received initial, accelerated U.S. Food and Drug Administration approval in 2019.

    September 27, 2022
    FDA Approves Durvalumab for Locally Advanced or Metastatic Biliary Tract Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Durvalumab for Locally Advanced or Metastatic Biliary Tract Cancer

    On September 2, 2022, the U.S. Food and Drug Administration approved durvalumab (Imfinzi®) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer.

    September 07, 2022
    Drug Clinical Trials Focus on Efficacy Over Quality of Life
    Oncology clinical trials

    Drug Clinical Trials Focus on Efficacy Over Quality of Life

    The clinical trials that lead to new drug approvals or expanded indications are quick to praise a therapy’s clinical benefits, such as longer survival or time to progression, but only about one in five of those trials find improvements in patients’ quality of life, researchers reported in JAMA Oncology.

    September 07, 2022
    FDA Approves Ibrutinib for Pediatric Patients With Chronic Graft-Versus-Host Disease, Including a New Oral Suspension
    U.S. Food and Drug Administration (FDA)

    FDA Approves Ibrutinib for Pediatric Patients With Chronic Graft-Versus-Host Disease, Including a New Oral Suspension

    On August 24, 2022, the U.S. Food and Drug Administration approved ibrutinib (Imbruvica®) for pediatric patients aged less than 1 year with chronic graft-versus-host disease after failure of one or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension.

    August 25, 2022
    Oncology Drug Reference Sheet: Nivolumab and Relatlimab-Rmbw
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Nivolumab and Relatlimab-Rmbw

    When OpdualagTM (nivolumab and relatlimab-rmbw), a fixed-dose combination therapy that consists of two distinct monoclonal antibodies, received FDA approval on March 18, 2022, for the treatment of unresectable or metastatic melanoma for adult and pediatric patients 12 years of age or older, it became the first approved combination therapy that includes two distinct immunotherapy agents in a single infusion. Relatlimab-rmbw is also the first approved lymphocyte activation gene-3–blocking antibody.

    August 23, 2022
    FDA Grants Accelerated Approval to Fam-Trastuzumab Deruxtecan-Nxki for HER2-Variant Non-Small Cell Lung Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Fam-Trastuzumab Deruxtecan-Nxki for HER2-Variant Non-Small Cell Lung Cancer

    On August 11, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu®) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 (HER2) variants, as detected by an FDA-approved test, and who have received a prior systemic therapy. This is the first drug approved for HER2-variant NSCLC.

    August 15, 2022
    FDA Approves Capmatinib for Metastatic Non-Small Cell Lung Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Capmatinib for Metastatic Non-Small Cell Lung Cancer

    On August 10, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to capmatinib (Tabrecta®) for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation leading to mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA-approved test.

    August 15, 2022
    FDA Approves Darolutamide Tablets for Metastatic Hormone-Sensitive Prostate Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Darolutamide Tablets for Metastatic Hormone-Sensitive Prostate Cancer

    On August 5, 2022, the U.S. Food and Drug Administration (FDA) approved darolutamide (Nubeqa®) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer.

    August 08, 2022
    FDA Approves Fam-Trastuzumab Deruxtecan-Nxki for HER2-Low Breast Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Fam-Trastuzumab Deruxtecan-Nxki for HER2-Low Breast Cancer

    On August 5, 2022, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu®) for use in adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH‑) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

    August 08, 2022
    Oncology Drug Reference Sheet: Lutetium Lu 177 Vipivotide Tetraxetan
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Lutetium Lu 177 Vipivotide Tetraxetan

    After clinical trial results demonstrated a four-month improvement in overall survival compared to best standard care, in March 2022 the U.S. Food and Drug Administration approved lutetium lu 177 vipivotide tetraxetan (PluvictoTM) to treat prostate-specific membrane antigen–expressing metastatic castration-resistant prostate cancer.

    July 26, 2022
    FDA Approves Crizotinib for Anaplastic Lymphoma Kinase-Positive Inflammatory Myofibroblastic Tumor
    U.S. Food and Drug Administration (FDA)

    FDA Approves Crizotinib for Anaplastic Lymphoma Kinase-Positive Inflammatory Myofibroblastic Tumor

    On July 14, 2022, the U.S. Food and Drug Administration (FDA) approved crizotinib (Xalkori®) for adult and pediatric patients aged 1 and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT).

    July 15, 2022
    FDA Warns About Risk of Death and Serious Side Effects With Duvelisib
    U.S. Food and Drug Administration (FDA)

    FDA Warns About Risk of Death and Serious Side Effects With Duvelisib

    On June 30, 2022, the U.S. Food and Drug Administration issued a drug safety communication for duvelisib (Copiktra®) after results from a clinical trial showed a possible increased risk of death associated with the agent, which is approved for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL who have received at least two prior therapies. The clinical trial results also associated duvelisib with a higher risk of serious side effects, including infections, diarrhea, lung and intestinal inflammation, skin reactions, and elevated liver enzymes.

    July 06, 2022
    FDA Approves Lisocabtagene Maraleucel for Second-Line Treatment of Large B-Cell Lymphoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Lisocabtagene Maraleucel for Second-Line Treatment of Large B-Cell Lymphoma

    On June 24, 2022, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel (Breyanzi®) for adult patients with large B-cell lymphoma (LBCL) whose disease is refractory to first-line chemoimmunotherapy, have relapsed within a year of first-line chemoimmunotherapy, or are not eligible for hematopoietic stem cell transplantation (HSCT) after relapse. It is not for patients with primary central nervous system lymphoma.

    June 30, 2022
    Oncology Drug Reference Sheet: Loncastuximab Tesirine-Lpyl
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Loncastuximab Tesirine-Lpyl

    Based on LOTIS-2 trial results that reported an overall response rate of nearly 50%, in April 2021 the U.S. Food and Drug Administration granted accelerated approval to loncastuximab tesirine-lpyl (ZynlontaTM) for adults with relapsed or refractory large B-cell lymphoma.

    June 21, 2022
    FDA Withdraws Approval of Umbralisib Because of Safety Concerns
    U.S. Food and Drug Administration (FDA)

    FDA Withdraws Approval of Umbralisib Because of Safety Concerns

    Because of safety concerns, the U.S. Food and Drug Administration (FDA) withdrew its approval of umbralisib (Ukoniq®) on June 1, 2022. Umbralisib had been approved to treat marginal zone lymphoma (MZL) and follicular lymphoma (FL).

    June 02, 2022
    FDA Approves Tisagenlecleucel for Relapsed or Refractory Follicular Lymphoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Tisagenlecleucel for Relapsed or Refractory Follicular Lymphoma

    On May 27, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisagenlecleucel (Kymriah®) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

    June 02, 2022
    FDA Approves Nivolumab in Combination With Chemotherapy and in Combination With Ipilimumab for First-Line Esophageal Squamous Cell Carcinoma Indications
    U.S. Food and Drug Administration (FDA)

    FDA Approves Nivolumab in Combination With Chemotherapy and in Combination With Ipilimumab for First-Line Esophageal Squamous Cell Carcinoma Indications

    On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo®) in combination with fluoropyrimidine- and platinum-based chemotherapy and nivolumab in combination with ipilimumab (Yervoy®) for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC).

    June 02, 2022
    FDA’s Industry Guidance Will Increase Racial and Ethnic Diversity in Clinical Trials
    Oncology clinical trials

    FDA’s Industry Guidance Will Increase Racial and Ethnic Diversity in Clinical Trials

    New draft guidance from the U.S. Food and Drug Administration (FDA) facilitates enrolling more participants from underrepresented racial and ethnic U.S. populations into industry clinical trials. According to FDA, despite their disproportionate burden for certain diseases, racial and ethnic minorities are frequently underrepresented in research and expanding diversity in clinical trials is an important step to reduce those disparities.

    June 02, 2022
    FDA Approves Ivosidenib in Combination With Azacitidine for Newly Diagnosed Acute Myeloid Leukemia
    U.S. Food and Drug Administration (FDA)

    FDA Approves Ivosidenib in Combination With Azacitidine for Newly Diagnosed Acute Myeloid Leukemia

    On May 25, 2022, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo®) in combination with azacitidine for patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 variant as detected by an FDA-approved test in adults aged 75 years or older or those who have comorbidities that preclude use of intensive induction chemotherapy.

    May 27, 2022
    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
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