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Showing 1201 - 1250FDA Grants Accelerated Approval to Lurbinectedin for Metastatic SCLC
On June 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lurbinectedin (Zepzelca) for adult patients with metastatic small cell lung cancer (SCLC) whose disease progressed on or after platinum-based chemotherapy. PM1183-B-005-14 Trial Efficacy was demonstrated in the...
FDA Approves Nine-Valent HPV Vaccine for the Prevention of Certain HPV-Related Head and Neck Cancers
On June 12, Merck announced that the U.S. Food and Drug Administration (FDA) had approved an expanded indication for Gardasil 9—a human papillomavirus (HPV) nine-valent vaccine—for the prevention of oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58....
FDA Approves Pegfilgrastim Biosimilar, Pegfilgrastim-apgf
On June 11, the U.S. Food and Drug Administration (FDA) approved a biosimilar to pegfilgrastim (Neulasta), pegfilgrastim-apgf (Nyvepria), to decrease the incidence of febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a...
FDA Approves Nivolumab for Pretreated Patients With Esophageal Squamous Cell Carcinoma
On June 10, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy. ATTRACTION-3 Efficacy was investigated in...
Niraparib for First-Line Maintenance Treatment of Advanced Ovarian Cancer
On April 29, 2020, niraparib was approved for maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.1,2 Supporting Efficacy Data Approval was based on...
KEYNOTE-555 Supports 6-Week Pembrolizumab Dosing Schedule in Melanoma
A less-frequent, more-convenient dosing schedule for pembrolizumab (400 mg every 6 weeks) was deemed safe and effective in patients with unresectable or metastatic melanoma, according to interim data from cohort B enrolled in the KEYNOTE-555 trial. These findings were presented at the 2020 Virtual...
FDA Approves Combination Regimens in NSCLC, HCC
On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved two combination regimens: ramucirumab (Cyramza) was approved in combination with erlotinib for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)...
Selpercatinib for Lung and Thyroid Cancers With RET Gene Mutations or Fusions
On may 8, 2020, selpercatinib was granted accelerated approval for the following indications: Adult patients with metastatic RET fusion-positive non–small cell lung cancer (NSCLC) Adult and pediatric patients ≥ 12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer who...
Ibrutinib in Combination With Rituximab in Chronic Lymphocytic Leukemia
On April 21, 2020, ibrutinib was granted an expanded indication for use in combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).1,2 The recommended dosage of ibrutinib in CLL/SLL is 420 mg, once daily,...
Olaparib Plus Bevacizumab in Maintenance Treatment for Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
On May 8, 2020, olaparib was granted an expanded indication to include use in combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line...
Sacituzumab Govitecan-hziy for Previously Treated Metastatic Triple-Negative Breast Cancer
On April 22, 2020, the antibody-drug conjugate sacituzumab govitecan-hziy was granted accelerated approval for treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.1,2 Supporting Efficacy Data Approval was...
Love of Science, Passion for Research, and Belief in the Power of the Immune System
Steven A. Rosenberg, MD, PhD, FASCO, knew from the start of his medical career that if treatments for cancer were to become curative, research in new therapies would have to move away from the mainstay one-size-fits-all approach of systemic chemotherapy to an innovative, personalized strategy that ...
Love of Science and a Family Tragedy Set the Course for This Breast Cancer Researcher
When oncology luminary Joyce A. O’Shaughnessy, MD, was in her early teens, her youngest sister, Teri, developed acute lymphocytic leukemia at age 5. Dr. O’Shaughnessy, the oldest of four girls, recalled that her sister’s struggle with the disease had a profound effect on her worldview. “Teri went...
Data From TAPUR Study Cohorts on Olaparib for BRCA-Mutated Advanced Prostate and Pancreatic Cancers
Positive results from two cohorts of the Targeted Agent and Profiling Utilization Registry (TAPUR) study provide real-world evidence to support recent clinical trial data that demonstrate a role for olaparib in the treatment of advanced prostate and pancreatic cancers with BRCA1/2-inactivating...
FDA Approves First-Line Ramucirumab Plus Erlotinib for Metastatic EGFR-Mutated NSCLC
On May 29, the U.S. Food and Drug Administration (FDA) approved ramucirumab (Cyramza, injection, 10 mg/mL solution) in combination with erlotinib for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19...
FDA Approves Atezolizumab Plus Bevacizumab for Patients With Unresectable or Metastatic HCC
On May 29, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The review of this application...
Lymphoma: Many Questions, Too Few Answers
The successful treatment of malignant lymphoma has been one of the great achievements in medical oncology, but certainly more work is needed to define key biologic targets as well as molecular markers for a more accurate definition of prognosis following therapy. In day-to-day practice, unanswered...
ASCO as a Public Organization: No Longer Hiding Our Lamp Under a Basket
Like many professional organizations in the public sphere, ASCO regularly confronts policy issues. Because we are a large organization, and because we represent many constituencies, we are frequently called upon to offer our advice to the federal government. Our members must sometimes wonder where...
Expert Point of View: Jonathan E. Rosenberg, MD
“These data are solid, showing a 7-month improvement in overall survival in patients with stable disease or better after first-line chemotherapy. This is roughly a 50% improvement in survival, which is clinically meaningful. Also, progression-free survival was significantly increased with...
FDA Approves Nivolumab/Ipilimumab Plus Chemotherapy for First-Line Treatment of Metastatic or Recurrent NSCLC
On May 26, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) and two cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non–small cell lung cancer (NSCLC) with no epidermal...
FDA Approves Brigatinib for ALK-Positive Metastatic NSCLC
On May 22, the U.S. Food and Drug Administration (FDA) approved brigatinib (Alunbrig) for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC) as detected by an FDA-approved test. The FDA also approved the Vysis ALK Break Apart FISH Probe Kit...
COVID-19 Evidence Accelerator Leverages Real-World Data
The Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) in collaboration with Friends of Cancer Research recently announced the COVID-19 Evidence Accelerator, an expansive public-private partnership combining the efforts of academic, government, and private sector organizations...
Roswell Park Investigators Study Immunotherapy Combination in Patients With Cancer Infected With COVID-19
A clinical trial investigating a two-drug immunotherapy combination will soon be available to patients with cancer infected with COVID-19 at Roswell Park Comprehensive Cancer Center in Buffalo. The U.S. Food and Drug Administration (FDA) has authorized clinical researchers at the center to conduct...
Tucatinib in Previously Treated HER2-Positive Metastatic Breast Cancer
On April 17, 2020, tucatinib was approved for use in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer. These patients included those with brain metastases and those who have received one or more prior...
Mitomycin Gel for Low-Grade Upper Tract Urothelial Cancer
On April 15, 2020, mitomycin gel was approved for the treatment of adult patients with low-grade upper tract urothelial cancer.1,2 Mitomycin gel is for pyelocalyceal use alone and not for intravenous, topical, or oral administration. Supporting Efficacy Data Approval was based on findings in the...
Luspatercept-aamt for Anemia in Adults With Myelodysplastic Syndromes
On April 3, 2020, luspatercept-aamt was approved in the treatment of anemia failing to respond to an erythropoiesis-stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks.1,2 The treatment is geared toward adult patients with very low– to intermediate-risk myelodysplastic ...
Selumetinib for Pediatric Neurofibromatosis Type 1 With Symptomatic, Inoperable Plexiform Neurofibromas
On April 10, 2020, the oral MEK inhibitor selumetinib was approved for the treatment of patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas.1,2 Selumetinib is the first therapy approved for children who have this disease....
Pemigatinib for Previously Treated Cholangiocarcinoma With FGFR2 Rearrangement or Fusion
On April 17, 2020, pemigatinib was granted accelerated approval for the treatment of adults with previously treated unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by a U.S. Food and Drug...
Expert Point of View: Thomas J. Herzog, MD
Thomas J. Herzog, MD, Deputy Director, University of Cincinnati Cancer Center, who presented a distillation of the PRIMA trial data along with updated results of the phase III PAOLA-1 trial of olaparib plus bevacizumab maintenance, called the data “practice-changing.” “We’ve suspected for a while...
Niraparib as First-Line Maintenance Therapy for Advanced Ovarian Cancers
Making sense of maintenance therapy in advanced ovarian cancer has been a tall order since the publication of impressive data for not one but three PARP inhibitors at the European Society for Medical Oncology (ESMO) 2019 Congress.1 The picture became a little clearer on April 29, 2020, however,...
FDA Approves Olaparib for HRR Gene–Mutated Metastatic Castration-Resistant Prostate Cancer
On May 19, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene–mutated metastatic castration-resistant prostate cancer who have had disease progression...
FDA Approves Atezolizumab for the First-Line Treatment of Patients With Metastatic NSCLC and High PD-L1 Expression
On May 18, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) for the first-line treatment of adult patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high programmed cell death ligand 1 (PD-L1) expression (PD-L1 stained ≥ 50% of tumor cells or...
FDA Pipeline: Two Breakthrough Therapy Designations for Fam-Trastuzumab Deruxtecan-nxki, and More
Over the past few weeks, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designations for an antibody-drug conjugate in the treatment of gastric and lung cancers. The Agency has also issued Orphan Drug designations for agents being investigated in chronic myeloid...
FDA Approves Rucaparib in BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
On May 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to rucaparib (Rubraca) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer who have been treated with androgen receptor–directed therapy...
FDA Approves Ripretinib for Previously Treated Patients With Advanced Gastrointestinal Stromal Tumor
On May 15, the U.S. Food and Drug Administration (FDA) approved ripretinib (Qinlock) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. INVICTUS Trial Efficacy was...
FDA Approves Nivolumab/Ipilimumab for First-Line Treatment of Patients With Metastatic NSCLC and PD-L1 Tumor Expression ≥ 1%
On May 15, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) as first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express programmed cell death ligand 1 (PD-L1) at ≥ 1%, as...
FDA Approves Pomalidomide for Kaposi Sarcoma
On May 14, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of pomalidomide (Pomalyst) to include treating adult patients with acquired immunodeficiency syndrome (AIDS)-related Kaposi sarcoma after failure of highly active antiretroviral therapy and those with Kaposi...
Cancer vs COVID-19: Clinical Trial Research During the Pandemic
The COVID-19 pandemic transformed cancer care, seemingly overnight, as practices scrambled to ensure a safe environment for caregivers and patients. Although regulatory burdens have been relaxed to allow patients to continue on trial treatment and telemedicine has expanded its competency and reach, ...
FDA Approves Selpercatinib for Lung and Thyroid Cancers With RET Mutations or Fusions
On May 8, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to selpercatinib (Retevmo) for the following indications: Adult patients with metastatic RET fusion–positive non–small cell lung cancer (NSCLC) Adult and pediatric patients ≥ 12 years of age with advanced or...
Durvalumab Plus Chemotherapy for Extensive-Stage Small Cell Lung Cancer
On March 27, 2020, durvalumab (Imfinzi) was approved for use in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer.1,2 Supporting Efficacy Data Approval was based on the findings of the open-label phase III ...
Encorafenib Combined With Cetuximab in Previously Treated BRAF V600E–Mutant Metastatic Colorectal Cancer
On April 8, 2020, encorafenib was approved for use in combination with cetuximab for the treatment of previously treated adult patients with metastatic colorectal cancer with a BRAF V600E mutation detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 Encorafenib is not indicated...
Understanding Patient-Reported Outcomes in Cancer Trials: A Beginner’s Guide
Patient-reported outcomes are measures used in clinical trials to capture aspects of a patient’s health condition, reported directly by the patient, without introduction of bias from third parties. They are distinct from the physical toxicities reported by clinicians1 and are collected using a...
Bispecific Antibodies Poised to Impact Treatment of Lymphoma and Other Blood Cancers
Studies of second-generation bispecific antibodies were among the highlights of the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition. The bispecific T-cell engager blinatumomab was the first such agent to be approved by the U.S. Food and Drug Administration (FDA) in...
Early Signs of Activity With Immunotherapies in Low-Incidence Cancers
Immunotherapy is showing promise for patients with rare cancers, offering new treatment opportunities and clinical trials to those with previously limited options. At the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium, presenters discussed the use of immunotherapy in three low-incidence cancers: ...
New Guideline on Systemic Therapy for Melanoma Tackles Rapid Developments in Treatment Options
Systemic treatment of melanoma has changed rapidly since the introduction of ipilimumab in 2011. Newer therapies approved for melanoma since that time include immunotherapy, targeted therapy for mutation-bearing tumors, and injectional therapy for cutaneous or palpable lesions. ASCO has released...
PARP Inhibitors in Maintenance Treatment for Advanced Ovarian Cancer
Based on multiple phase III prospective trials, there is evidence that both PARP inhibitors and antiangiogenic therapies such as bevacizumab provide benefit when utilized in a maintenance strategy in the first-line treatment of advanced epithelial ovarian cancer (GOG 218, ICON7, SOLO-1, PRIMA,...
FDA Approves Olaparib Plus Bevacizumab as Maintenance Treatment for Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
On May 8, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of olaparib (Lynparza) to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in...
FDA Approves Capmatinib for Patients With Metastatic NSCLC With Confirmed MET Exon 14 Skipping
On May 6, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to capmatinib (Tabrecta) for adult patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by...
Issues With Travel Faced by Patients Undergoing Lu-177 Dotatate Radiation Therapy
A team of researchers and patient advocates have addressed the challenges related to traveling after receiving radiation therapy involving Lu-177 dotatate in a study published by Kendi et al in The Journal of Nuclear Medicine. Due to the residual radiation activity of Lu-177 dotatate, some patients ...
FDA Issues Emergency Use Authorization for Remdesivir for Treatment of Severe COVID-19
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as low...
