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    Two Oncology Nurses Implement Process to Allow Patients to Disconnect Pumps From the Comfort of Their Own Homes
    Chemotherapy
    Two Oncology Nurses Implement Process to Allow Patients to Disconnect Pumps From the Comfort of Their Own Homes
    May 19, 2023
    Innovative Oncology Nurses Break Down Communication Barriers for Patients Who Are Deaf or Hard of Hearing
    Special Populations
    Innovative Oncology Nurses Break Down Communication Barriers for Patients Who Are Deaf or Hard of Hearing
    March 10, 2023
    How I Practice Mindfulness as an Oncology Nurse
    Nurse well-being
    How I Practice Mindfulness as an Oncology Nurse
    March 03, 2023
    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
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    Oncology drug research

    FDA Approves Olaparib Plus Abiraterone and Prednisone or Prednisolone for BRCA-Variant, Metastatic, Castration-Resistant Prostate Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Olaparib Plus Abiraterone and Prednisone or Prednisolone for BRCA-Variant, Metastatic, Castration-Resistant Prostate Cancer

    On May 31, 2023, the U.S. Food and Drug Administration approved olaparib (Lynparza®) plus abiraterone and prednisone or prednisolone for adult patients with deleterious or suspected deleterious BRCA variant, metastatic, castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test.

    June 01, 2023
    Oncology Drug Reference Sheet: Mosunetuzumab-Axgb
    Oncology drug research

    Oncology Drug Reference Sheet: Mosunetuzumab-Axgb

    In an open-label, multicenter, multicohort study that included 90 patients with relapsed or refractory follicular lymphoma who had received at least two prior lines of systemic therapy, 60% of patients receiving treatment with mosunetuzumab-axgb achieved a complete response and 80% had an overall response. On December 22, 2022, the U.S. Food and Drug Administration granted mosunetuzumab-axgb accelerated approval based on those findings.

    May 23, 2023
    FDA Grants Accelerated Approval to Epcoritamab-Bysp for Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade B-Cell Lymphoma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Epcoritamab-Bysp for Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade B-Cell Lymphoma

    On May 19, 2023, the U.S. Food and Drug Administration granted accelerated approval to epcoritamab-bysp (Epkinly®) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy.

    May 22, 2023
    Oncology Drug Reference Sheet: Nadofaragene Firadenovec-Vncg
    U.S. Food and Drug Administration (FDA)

    Oncology Drug Reference Sheet: Nadofaragene Firadenovec-Vncg

    Under the U.S. Food and Drug Administration’s (FDA’s) fast-track approval process, nadofaragene firadenovec-vncg (Adstiladrin®) became the first gene therapy approved for the treatment of high-risk non-muscle invasive bladder cancer. Approximately 75% of newly diagnosed bladder cancers are classified as non-muscle invasive. Bacillus Calmette Guérin has been used as first-line therapy for more than 20 years, but eventually 30%–50% of patients stop responding, and nadofaragene firadenovec-vncg offers a new treatment option. FDA’s December 2022 approval was based on complete response (CR) and duration of response from Study CS-003, which demonstrated a 46% CR for at least one year.

    April 25, 2023
    FDA Approves Polatuzumab Vedotin-piiq for Previously Untreated Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, and High-Grade B-Cell Lymphoma
    U.S. Food and Drug Administration (FDA)

    FDA Approves Polatuzumab Vedotin-piiq for Previously Untreated Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, and High-Grade B-Cell Lymphoma

    On April 19, 2023, the U.S. Food and Drug Administration approved polatuzumab vedotin-piiq (Polivy®) with rituximab, cyclophosphamide, doxorubicin, and prednisone for adult patients who have previously untreated diffuse large B-cell lymphoma, not otherwise specified, or high-grade B-cell lymphoma and who have an International Prognostic Index score of 2 or greater.

    April 20, 2023
    FDA Approves Omidubicel-onlv to Reduce Time to Neutrophil Recovery and Infection in Patients With Hematologic Malignancies
    U.S. Food and Drug Administration (FDA)

    FDA Approves Omidubicel-onlv to Reduce Time to Neutrophil Recovery and Infection in Patients With Hematologic Malignancies

    On April 17, 2023, the U.S. Food and Drug Administration approved omidubicel-onlv (Omisirge®) for use in adult and pediatric patients aged 12 years and older with hematologic malignancies receiving umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

    April 19, 2023
    Modified Chemo Drug Kills More Cancer Cells, Activates Immune Cells—and Has Fewer Toxicities
    Chemotherapy

    Modified Chemo Drug Kills More Cancer Cells, Activates Immune Cells—and Has Fewer Toxicities

    Once abandoned because of dose-limiting toxicities, a novel chemotherapy drug is showing even more promise as a modified prodrug. In study results published in Science Advances, researchers demonstrated how turning DRP-104 into a prodrug enables it to kill more tumor cells and activate CD8+ T cells with a “markedly improved tolerability profile.”

    April 19, 2023
    FDA Grants Accelerated Approval to Enfortumab Vedotin-Ejfv With Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Enfortumab Vedotin-Ejfv With Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma

    On April 3, 2023, the U.S. Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev®) with pembrolizumab (Keytruda®) for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

    April 05, 2023
    Oncology Drug Reference Sheet: Pemigatinib
    U.S. Food and Drug Administration (FDA)

    Oncology Drug Reference Sheet: Pemigatinib

    When the U.S. Food and Drug Administration (FDA) granted pemigatinib (Pemazyre®) a new indication in August 2022, it became the first targeted therapy approved for treatment of patients with relapsed or refractory myeloid or lymphoid neoplasms (MLNs) with fibroblast growth factor receptor (FGFR) 1 rearrangement. In 2021, FDA gave pemigatinib accelerated approval for patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement as detected by an FDA-approved test.

    March 28, 2023
    FDA Grants Accelerated Approval to Retifanlimab-Dlwr for Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Retifanlimab-Dlwr for Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma

    On March 22, 2023, the U.S. Food and Drug Administration granted accelerated approval to retifanlimab-dlwr (Zynyz®) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.

    March 23, 2023
    FDA Approves Dabrafenib With Trametinib for Pediatric Patients With Low-Grade Glioma and a BRAF V600E Variant
    U.S. Food and Drug Administration (FDA)

    FDA Approves Dabrafenib With Trametinib for Pediatric Patients With Low-Grade Glioma and a BRAF V600E Variant

    On March 16, 2023, the U.S. Food and Drug Administration approved dabrafenib (Tafinlar®) with trametinib (Mekinist®) for pediatric patients aged one year and older with low-grade glioma (LGG) that have a BRAF V600E variant who require systemic therapy. FDA also approved new oral formulations of both drugs for patients who cannot swallow pills. It is the first FDA approval of a systemic therapy for first-line treatment of pediatric patients with LGG that have a BRAF V600E variant.

    March 20, 2023
    FDA Expands Early Breast Cancer Indication for Abemaciclib With Endocrine Therapy
    U.S. Food and Drug Administration (FDA)

    FDA Expands Early Breast Cancer Indication for Abemaciclib With Endocrine Therapy

    On March 3, 2023, the U.S. Food and Drug Administration approved abemaciclib (Verzenio®) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer who are at high risk for recurrence.

    March 07, 2023
    Oncology Drug Reference Sheet: Futibatinib
    Drug Reference Sheet

    Oncology Drug Reference Sheet: Futibatinib

    Patients with rare cancers like intrahepatic cholangiocarcinoma seldom have many additional treatment options if their tumors become resistant to first-line therapy: From August 1, 2021–July 31, 2022, the U.S. Food and Drug Administration approved only five new agents or indications for rare tumors. On September 30, 2022, FDA added one more, giving futibatinib (Lytgobi™) accelerated approval for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements. The approval was based on the drug’s 42% overall response rate and median duration of response of 9.7 months.

    February 28, 2023
    FDA Grants Regular Approval to Dostarlimab-Gxly for dMMR Endometrial Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Grants Regular Approval to Dostarlimab-Gxly for dMMR Endometrial Cancer

    On February 9, 2023, the U.S. Food and Drug Administration approved dostarlimab-gxly (Jemperli®) for adult patients with mismatch repair deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

    February 10, 2023
    FDA Approves Sacituzumab Govitecan-Hziy for HR-Positive Breast Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Sacituzumab Govitecan-Hziy for HR-Positive Breast Cancer

    On February 3, 2023, the U.S. Food and Drug Administration approved sacituzumab govitecan-hziy (Trodelvy®) for unresectable locally advanced or metastatic hormone receptor–positive, human epidermal growth factor receptor 2–negative (IHC 0, IHC 1+, or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

    February 06, 2023
    FDA Approves Elacestrant for ER-Positive, HER2-Negative, ESR1-Variant Advanced or Metastatic Breast Cancer
    U.S. Food and Drug Administration (FDA)

    FDA Approves Elacestrant for ER-Positive, HER2-Negative, ESR1-Variant Advanced or Metastatic Breast Cancer

    On January 27, 2023, the U.S. Food and Drug Administration approved elacestrant (Orserdu®) for postmenopausal women or adult men with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-variant advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

    January 31, 2023
    FDA Approves Pembrolizumab as Adjuvant Treatment for Non-Small Cell Lung Cancer
    U.S. Food and Drug Administration (FDA)

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

    On January 26, 2023, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda®) for adjuvant treatment following resection and platinum-based chemotherapy of patients with stage IB (T2a ≥ 4 cm), II, or IIIA non-small cell lung cancer.

     

    January 30, 2023
    FDA Grants Accelerated Approval to Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
    U.S. Food and Drug Administration (FDA)

    FDA Grants Accelerated Approval to Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

    On January 27, 2023, the U.S. Food and Drug Administration granted accelerated approval to pirtobrutinib (Jaypirca®) for relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor.

    January 30, 2023
    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. The approval was based on clinical trial findings demonstrating that the agent improved overall survival and significantly delayed time to pain progression compared to placebo.

    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
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