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Showing 801 - 850Characteristics of Genomically Targeted Single-Patient Use Requests for Pediatric Cancers
In a study reported in the Journal of Clinical Oncology, Sabnis et al analyzed characteristics of genomically targeted single-patient use requests for investigational agents for the treatment of pediatric cancers. These requests were made from pediatric cancer programs over a 5-year period. As...
AACR Cancer Progress Report 2021 Showcases 50 Years of Advances in Cancer Research and Treatment
The AACR Cancer Progress Report 2021 celebrates the gains made in cancer research since the National Cancer Act was signed into law on December 23, 1971. The report also recognizes the negative impact the COVID-19 pandemic has had on cancer research and patient care, the disproportionate toll both...
FDA Approves Pembrolizumab Combination for the First-Line Treatment of Cervical Cancer
On October 13, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score [CPS] ≥ 1), as...
FDA Approves Abemaciclib in Combination With Endocrine Therapy for Early Breast Cancer
On October 12, the U.S. Food and Drug Administration (FDA) approved abemaciclib (Verzenio) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, node-positive early breast cancer...
Recent FDA Approvals in Breast Cancer
In the past year, the U.S. Food and Drug Administration (FDA) approved five treatment options for patients with breast cancer, which are summarized herein. Abemaciclib Combination On October 12, 2021, the FDA approved abemaciclib (Verzenio) with endocrine therapy (tamoxifen or an aromatase...
Expert Point of View: Yuan Yuan, MD, PhD and Elizabeth Mittendorf, MD, PhD
Yuan Yuan, MD, PhD, a medical oncologist at City of Hope, Duarte, California, weighed in on the KEYNOTE-355 findings. “The study presented by Dr. Rugo on KEYNOTE-355 reconfirms the utility of adding immune checkpoint inhibitors to chemotherapy as front-line treatment for metastatic triple-negative ...
KEYNOTE-355: Pembrolizumab Plus Chemotherapy Improves Progression-Free Survival in PD-L1–Enriched Advanced Triple-Negative Breast Cancer
Pembrolizumab plus chemotherapy improved progression-free survival vs chemotherapy alone as first-line treatment of advanced or metastatic triple-negative breast cancer, according to the results of KEYNOTE-355.1 Progression-free survival was significantly improved with pembrolizumab plus...
KEYNOTE-522: Neoadjuvant Pembrolizumab Improves Event-Free Survival in Triple-Negative Breast Cancer
The latest analysis of the phase III KEYNOTE-522 trial demonstrated significant improvements in clinical outcomes with pembrolizumab plus chemotherapy vs chemotherapy alone as a neoadjuvant/adjuvant treatment of triple-negative breast cancer.1 This is the first large, randomized, phase III trial to ...
Early Triple-Negative Breast Cancer: Are Checkpoint Inhibitors Ready for Neoadjuvant or Adjuvant Use?
Recent clinical trials have been encouraging for the neoadjuvant or adjuvant use of immune checkpoint inhibitors in triple-negative breast cancer, but is this approach ready for the clinic? This question was addressed at the 38th Miami Breast Cancer Conference, held virtually this year, by Adam M....
Novel HER2-Targeted Therapies Pose Sequencing Challenges
With three new HER2-targeted therapies approved over the past year or two alone, the treatment landscape for patients with metastatic breast cancer has become increasingly crowded. In the third-line setting and beyond, there are now at least eight HER2-targeted agents approved by the U.S. Food and...
OlympiA Trial: Adjuvant Olaparib Extends Disease-Free Survival in BRCA-Mutated Early Breast Cancer
Adjuvant therapy with the PARP inhibitor olaparib for 1 year extended disease-free survival in patients with high-risk early-stage HER2-negative breast cancer with BRCA1/2 germline (inherited) mutations, according to a prespecified interim analysis of the phase III OlympiA trial presented at the...
FDA Pipeline: Recent Reviews, Designations, Applications, and Authorizations in the Oncology Space
Over the past month, the U.S. Food and Drug Administration (FDA) issued several regulatory decisions for novel treatments for patients with cancer. Priority Review for Relatlimab and Nivolumab Fixed-Dose Combination in Unresectable or Metastatic Melanoma The FDA accepted for Priority Review the...
FDA Recognizes Memorial Sloan Kettering Database of Molecular Tumor Marker Information
On October 7, the U.S. Food and Drug Administration (FDA) granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center Oncology Knowledge Base (OncoKB) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases. The FDA recognized a...
Maintenance Durvalumab: Increased Utilization May Improve Outcomes in NSCLC
Maintenance durvalumab, the standard-of-care treatment for patients with unresectable stage III non–small cell lung cancer (NSCLC), remains significantly underutilized, according to data presented at the International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung...
Adding Value to Clinical Decision-Making in Nonmetastatic Castration-Resistant Prostate Cancer
Several recent investigations have led to the U.S. Food and Drug Administration (FDA) approval of novel antiandrogens to treat nonmetastatic castration-resistant prostate cancer. Yet, this work has not addressed the treatment of nonmetastatic hormone-sensitive biochemically recurrent prostate...
FDA Approves Brexucabtagene Autoleucel for Relapsed or Refractory B-Cell Precursor ALL
On October 1, the U.S. Food and Drug Administration (FDA) approved brexucabtagene autoleucel (Tecartus), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). ZUMA-3 Efficacy was evaluated ...
FDA Expands Cetuximab Label With Combination of Encorafenib for Pretreated BRAF V600E Mutation–Positive Metastatic Colorectal Cancer
The U.S. Food and Drug Administration (FDA) has granted approval of a new indication for cetuximab (Erbitux) in combination with encorafenib (Braftovi) for the treatment of adult patients with metastatic colorectal cancer and a BRAF V600E mutation, as detected by an FDA-approved test, after prior...
Classifying EGFR Mutations by Structure and Function May Help to Match Patients With NSCLC to More Effective Treatments
Researchers have discovered that grouping EGFR mutations by structure and function provides an accurate framework to match patients with non–small cell lung cancer (NSCLC) to the right drugs. The findings, published by Robichaux et al in Nature, identify four subgroups of mutations and introduce a...
Ivosidenib for Previously Treated IDH1-Mutant Advanced or Metastatic Cholangiocarcinoma
On August 25, 2021, ivosidenib was approved for adults with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1 The FDA simultaneously approved the Oncomine Dx Target Test as a...
Dostarlimab-gxly for Mismatch Repair–Deficient Recurrent or Advanced Solid Tumors
On August 17, 2021, dostarlimab-gxly, aPD-1 blocking monoclonal antibody, was granted accelerated approval for adults with mismatch repair–deficient (dMMR) recurrent or advanced solid tumors, as determined by a U.S. Food and Drug Administration (FDA)-approved test, who have had disease progression...
ASCO 2021: Roundup of Studies You May Have Missed
As ASCO Annual Meeting attendees know by now, clinicians don’t have to be at McCormick Place to hear practice-changing findings and forward-looking advances in the field of oncology. Interesting content was no exception at the 2021 conference, so in addition to covering the biggest news from the...
FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations
The U.S. Food and Drug Administration (FDA) has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow for the use of a single booster dose to be administered at least 6 months after completion of the primary series in individuals aged 65 years and older;...
Ruxolitinib Granted FDA Approval for Chronic Graft-vs-Host Disease
On September 22, the U.S. Food and Drug Administration approved ruxolitinib (Jakafi), a JAK inhibitor, for the treatment of chronic graft-vs-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older. REACH3 Efficacy was...
FDA Grants Accelerated Approval to Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer
On September 20, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv (Tivdak), a tissue factor–directed antibody and microtubule inhibitor conjugate, for adult patients with recurrent or metastatic cervical cancer who experienced disease progression on ...
FDA Approves Cabozantinib for Patients With Previously Treated Radioactive Iodine–Refractory Differentiated Thyroid Cancer
On September 17, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) for the treatment of adult and pediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior vascular endothelial growth...
FDA Grants Accelerated Approval to Mobocertinib for Patients With Metastatic NSCLC and EGFR Exon 20 Insertion Mutations
� On September 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to mobocertinib (Exkivity) for adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) and EGFR exon 20 insertion mutations (as detected by an FDA-approved test) whose disease has...
Recent FDA Approvals in Endometrial Cancer
In recent months, the U.S. Food and Drug Administration approved two treatment options for patients with endometrial cancer, which are summarized herein. Dostarlimab-gxly for dMMR Endometrial Cancer On April 22, 2021, the FDA granted accelerated approval to dostarlimab-gxly (Jemperli) for adult...
With the Exception of Cervical Cancer, HPV-Associated Cancers Are on the Rise, Especially in Older Adults
Although the incidence of cervical cancer has decreased 1.03% a year over the past 17 years in the United States, likely due to screening or vaccination, other human papillomavirus (HPV)-associated cancers are increasing in both men and women, according to a study by Cheng-I Liao, MD, currently of...
Gynecologic Cancers 2020–2021 Almanac
The past year has been a remarkable and noteworthy time with much exciting progress made in gynecologic cancers, despite the underlying presence of the COVID-19 pandemic. Several key studies were presented in 2020–2021 that detailed the results of novel therapies for our patients with cervical,...
Sotorasib: Subgroup Analysis of Phase II Trial Shows Activity With KRAS Inhibitor in Lung Cancer
The KRAS-specific inhibitor sotorasib achieved responses in patients with KRAS G12C–mutated non–small lung cancer (NSCLC) who had experienced disease progression on platinum-based chemotherapy, immunotherapy, or both treatments. The objective response rate was 37.1%, and responses extended to all...
Atezolizumab Reduces Risk of Disease Progression in Patients With PD-L1–Expressing Early-Stage NSCLC
Atezolizumab given after chemotherapy to patients with resected stage II to IIIA non–small cell lung cancer (NSCLC) significantly improved disease-free survival compared with best supportive care alone in patients whose tumors expressed PD-L1.1 These results of the global phase III IMpower010 trial ...
OlympiA Trial: Adjuvant Olaparib Extends Disease-Free Survival in BRCA-Mutated Early Breast Cancer
Adjuvant therapy with the PARP inhibitor olaparib for 1 year extended disease-free survival in patients with high-risk early-stage HER2-negative breast cancer with BRCA1/2 germline (inherited) mutations, according to a prespecified interim analysis of the phase III OlympiA trial presented at the...
VISION Trial: Novel PSMA-Targeted Radiotherapy Improves Outcomes in Metastatic Prostate Cancer
Lutetium-177–PSMA-617 (LuPSMA)—an investigational radiolabeled small molecule—significantly improved radiographic progression-free survival and overall survival when added to the standard of care compared with the standard of care alone for men with metastatic castration-resistant prostate cancer...
FDA Grants Zanubrutinib Accelerated Approval in Relapsed or Refractory Marginal Zone Lymphoma
On September 15, zanubrutinib (Brukinsa), a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK), received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least...
Novel Monoclonal Antibody Emerges as Potential First-Line Standard in Nasopharyngeal Cancer
A new first-line standard of care may be emerging for recurrent or metastatic nasopharyngeal carcinoma, based on the findings of the global phase III JUPITER-02 trial presented at the 2021 ASCO Annual Meeting by investigators from China.1 In the study, toripalimab, an anti–PD-1 monoclonal antibody, ...
Maintenance Durvalumab: Increased Utilization Could Improve NSCLC Outcomes
Maintenance durvalumab—the recommended maintenance treatment for patients with unresectable stage III non–small cell lung cancer (NSCLC) following chemoradiation—remains significantly underutilized, according to research presented by Liu et al at the International Association for the Study of Lung...
Novel Urine-Based Test Evaluated in Prostate Cancer Detection and Risk Stratification
In a validation study with data presented at the American Urological Association’s 2021 Annual Meeting, clinician-researchers reported that a new test (miR Sentinel PCC4 Test) may be able to detect and risk-classify prostate cancer at the molecular level with predictive accuracy based on a single...
Racial Disparities Among Men With Prostate Cancer
Despite great strides in prostate cancer treatment over the past several years, racial disparities in care persist, according to new data presented during the 2021 Annual Meeting of the American Urological Association (AUA). Three studies highlighting this topic were presented during a virtual...
Amivantamab-vmjw for Previously Treated Advanced NSCLC With EGFR Mutation
On May 21, 2021, amivantamab-vmjw, a bispecific antibody directed against EGFR and MET receptors, was granted accelerated approval for treatment of adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by a U.S. Food and...
Pembrolizumab Combined With Trastuzumab and Chemotherapy for HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
On May 5, 2021, pembrolizumab was granted accelerated approval for use in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal...
Dana-Farber Cancer Institute Establishes the David Liposarcoma Research Initiative
Dana-Farber Cancer Institute announced that The Rossy Foundation has committed $10 million to establish the David Liposarcoma Research Initiative. The 5-year initiative will conduct groundbreaking research into liposarcoma at Dana-Farber and external collaborating partner institutions, with the aim ...
Assumptions, Data … and More Questions!
I read with great interest the results from the phase II ZUMA-12 study of axicabtagene ciloleucel, presented during the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition.1 But the results raised several questions for me. Axicabtagene ciloleucel, an autologous anti-CD19...
FDA Approves Zanubrutinib for Waldenström’s Macroglobulinemia
On August 31, the U.S. Food and Drug Administration (FDA) approved zanubrutinib (Brukinsa), a Bruton’s tyrosine kinase inhibitor, for adult patients with Waldenström’s macroglobulinemia. ASPEN Trial Zanubrutinib was investigated in ASPEN (ClinicalTrials.gov identifier: NCT03053440), a randomized,...
FDA Revises Label for Pembrolizumab in Patients With Advanced Urothelial Carcinoma
On August 31, the U.S. Food and Drug Administration (FDA) revised the label for the anti–PD-1 therapy pembrolizumab for its indication in first-line advanced urothelial carcinoma. The FDA converted the indication from an accelerated approval to a full approval. In addition, as part of the label...
Prostate Cancer Diagnostics: Novel Approaches Are Leaving Conventional Imaging Behind
Advances in molecular imaging are having a big impact on prostate cancer management and outcomes, according to Ashesh B. Jani, MD, the James C. Kennedy Professor in Prostate Cancer, Department of Radiation Oncology at the Winship Cancer Institute of Emory University, Atlanta. Dr. Jani described his ...
Update to NCCN: Cancer and COVID-19 Vaccination Guidance Announced
Today, the National Comprehensive Cancer Network® (NCCN®) announced significant updates to the NCCN: Cancer and COVID-19 Vaccination guidance. This is the fourth version of NCCN’s COVID-19 vaccination guide and incorporates the latest data plus recent approvals from the U.S. Food and Drug...
Update on U.S. Indication for Atezolizumab in PD-L1–Positive Metastatic Triple-Negative Breast Cancer
Genentech, a member of the Roche Group, announced that it has made the decision to voluntarily withdraw the U.S. accelerated approval for atezolizumab (Tecentriq) in combination with nab-paclitaxel for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast...
Recent FDA Approvals in dMMR Solid Tumors and von Hippel Lindau–Associated Cancers
This week, we’ll be reviewing two recent FDA approvals in the oncology space, for patients with mismatch repair–deficient, or dMMR, recurrent or advanced solid tumors, and for adult patients with cancers associated with von Hippel-Lindau disease.
FDA Approves Ivosidenib for Advanced or Metastatic IDH1-Mutated Cholangiocarcinoma
On August 25, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo), a small-molecule inhibitor of isocitrate dehydrogenase-1 (IDH1), for adult patients with previously treated locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved ...
FDA Pipeline: Reviews for Agents in Acute Graft-vs-Host Disease, Nasopharyngeal and Ovarian Cancers
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to an agent for the prevention of acute graft-vs-host disease; Breakthrough Therapy designation to an anti–PD-1 monoclonal antibody for the treatment of metastatic nasopharyngeal carcinoma; and Fast Track designation to a ...
