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Showing 1201 - 1250Can Use of an Algorithm Improve the Accuracy and Efficiency of Cervical Cancer Screening?
In a new study published by Wentzensen et al in the Journal of the National Cancer Institute, a computer algorithm improved the accuracy and efficiency of cervical cancer screening compared with cytology (Papanicolaou [Pap] test), the current standard for follow-up of women who test positive in...
FDA Pipeline: Agents for the Treatment of Prostate and Pancreatic Cancers, Marginal Zone Lymphoma
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to relugolix for the treatment of advanced prostate cancer; Fast Track designation to a radioimmunotherapeutic treatment for marginal zone lymphoma; and Orphan Drug designation to a novel monoclonal antibody for...
Can Use of an Algorithm Improve the Accuracy and Efficiency of Cervical Cancer Screening?
In a new study published by Wentzensen et al in the Journal of the National Cancer Institute, a computer algorithm improved the accuracy and efficiency of cervical cancer screening compared with cytology (Papanicolaou [Pap] test), the current standard for follow-up of women who test positive in...
Study Supports Pembrolizumab Plus Axitinib in Previously Untreated Advanced Renal Cell Carcinoma
Extended analysis of the phase III KEYNOTE-426 study upholds pembrolizumab plus axitinib as a preferred front-line regimen over sunitinib in patients with advanced sporadic renal cell carcinoma.1 These updated results were presented at the ASCO20 Virtual Scientific Program by Elizabeth R. Plimack,...
FDA Approves Maintenance Avelumab for the Treatment of Advanced Urothelial Carcinoma
On June 30, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. JAVELIN Bladder 100 Efficacy of avelumab...
FDA Approves Pembrolizumab for the First-Line Treatment of MSI-H/dMMR Colorectal Cancer
On June 29, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) colorectal cancer. KEYNOTE-177 Approval was based on...
FDA Approves Combination of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf for HER2-Positive Breast Cancer
On June 29, the U.S. Food and Drug Administration (FDA) approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) for subcutaneous injection in the following indications: Use in combination with chemotherapy as: Neoadjuvant treatment for patients with...
Capmatinib for Metastatic NSCLC With MET Exon 14 Skipping Mutation
On May 6, 2020, the oral mesenchymal-epithelial transition (MET) kinase inhibitor capmatinib was granted accelerated approval for the treatment of adult patients who have metastatic non–small cell lung cancer (NSCLC) with tumors that have a mutation that leads to MET exon 14 skipping, as detected...
Pomalidomide for Treatment of Kaposi Sarcoma
On May 14, 2020, pomalidomide was granted accelerated approval to treat adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy and for Kaposi sarcoma in adult patients who are HIV-negative.1,2 Pomalidomide is available only through the restricted...
ASCO20 Virtual Scientific Program: Next-Generation Oncology Highlights
The ASCO20 Virtual Scientific Program was different in many ways, not only because of the virtual modality forced by the COVID-19 pandemic, but also because of the resilience of the scientific society and my colleagues around the world. I’m in the plenary session of the ASCO 2025 Annual Meeting....
Brigatinib for ALK-Positive Metastatic Non–Small Cell Lung Cancer
On May 22, 2020, brigatinib was approved for the treatment of adult patients with ALK-positive, metastatic non–small cell lung cancer (NSCLC), as detected by a U.S. Food and Drug Administration (FDA)-approved test.1,2 The FDA also approved the Vysis ALK Break Apart FISH Probe Kit as a companion...
Ramucirumab Plus Erlotinib in Treatment of EGFR-Mutant Metastatic NSCLC
On May 29, 2020, ramucirumab was approved for use in combination with erlotinib for first-line treatment of metastatic non–small cell lung cancer (NSCLC) with EGFR exon 19 deletion or exon 21 (L858R) substitution mutation.1,2 Supporting Efficacy Data Approval was based on findings from the...
Olaparib for Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
On May 19, 2020, olaparib was approved for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer who experienced disease progression after treatment with...
Ripretinib in Previously Treated Advanced Gastrointestinal Stromal Tumor
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 15, 2020, the receptor tyrosine kinase inhibitor...
Newer Late-Line Treatments May Change Front-Line Standard of Care in HER2-Positive Metastatic Breast Cancer
First- and second-line treatments of HER2-positive metastatic breast cancer have become the standard of care based on solid gains in overall survival, but the prevalence of resistance to these agents is increasing; up to 55% of patients will ultimately develop brain metastases. According to a pair...
FDA Approves Pembrolizumab for Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma
On June 24, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable with surgery or radiation. KEYNOTE-629 Efficacy was investigated in KEYNOTE-629, a multicenter, multicohort,...
Underrepresentation of Black Patients in Cancer Clinical Trials: Public vs Pharmaceutical Sponsorship
Black patients are better represented in taxpayer-funded cancer clinical trials compared to trials run by pharmaceutical companies, although they remain underrepresented in clinical trials, regardless of sponsor. These results were published by Joseph M. Unger, PhD, and colleagues in JNCI Cancer...
FDA Announces Project Patient Voice to Communicate Patient-Reported Outcomes From Cancer Clinical Trials
The U.S. Food and Drug Administration (FDA) has launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE). Through a new website, Project Patient Voice creates a consistent source of publicly available information describing patient-reported symptoms from cancer ...
FDA Approves Selinexor for Relapsed or Refractory DLBCL
On June 22, the U.S. Food and Drug Administration (FDA) approved oral selinexor (Xpovio), a first-in-class, selective inhibitor of nuclear export compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified after at least...
Expert Point of View: Scott N. Gettinger, MD
Discussant for the CheckMate 227 and CheckMate 9LA trials, Scott N. Gettinger, MD, of Yale Cancer Center in New Haven, Connecticut, said: “There is tremendous interest in lung cancer to combine nivolumab plus ipilimumab, driven by the melanoma experience. However, combinations of immunotherapy come ...
Positive Findings in NSCLC for First-Line Nivolumab Plus Ipilimumab With or Without Chemotherapy
It is becoming more challenging to select first-line therapy for advanced non–small cell lung cancer (NSCLC) for patients whose tumors have no EGFR or ALK alterations. The results of two different studies presented at the ASCO20 Virtual Scientific Program—CheckMate 227 and CheckMate 9LA—support the ...
FDA Pipeline: Fast Track Designations in Colorectal and Pancreatic Cancers, Lymphoplasmacytic Lymphoma/Waldenström’s Macroglobulinemia
Over the past month, the U.S. Food and Drug Administration has granted Fast Track designation to agents designed to treat colorectal and pancreatic cancers, in addition to lymphoplasmacytic lymphoma/Waldenström’s macroglobulinemia; accepted a new drug application for a treatment for relapsed or...
FDA Grants Accelerated Approval to Tazemetostat for Some Patients With Follicular Lymphoma
On June 18, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik), an EZH2 inhibitor, for adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have...
FDA Approves Pembrolizumab for Adults and Children With Tumor Mutational Burden–High Solid Tumors
On June 16, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden–high (TMB-H; ≥ 10 mutations/megabase [mut/Mb]) solid tumors, as determined by an ...
FDA Extends Indication of Gemtuzumab Ozogamicin for Pediatric Patients With CD33-Positive AML
On June 16, the U.S. Food and Drug Administration (FDA) extended the indication of gemtuzumab ozogamicin (Mylotarg) for newly diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients aged 1 month and older. AAML0531 Efficacy and safety in the pediatric population were...
FDA 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...
