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Showing 1551 - 1600Study Shows Benefit With Pazopanib in Treatment of Carcinoid Tumors
Pazopanib significantly improved progression-free survival by 47% in patients with progressive carcinoid tumors, in a prospective randomized phase II trial presented at the 2019 ASCO Annual Meeting.1 “With these results, Alliance A021202 becomes the first randomized study to show that the vascular...
SNMMI 2019: Vest to Personalize Lu-177 Dotatate Therapy for Neuroendocrine Tumors
Researchers at the University of Washington are developing a user-friendly vest with technology that collects data to tailor personalized therapy for patients with metastatic, somatostatin receptor 2–positive neuroendocrine tumors (NETs). Their study was presented at the 2019 Annual Meeting...
Project Facilitate: FDA’s Plan to Ease Expanded Access to Novel Therapies
The U.S. Food and Drug Administration (FDA) plans to provide oncologists with greater help in acquiring expanded access to investigational therapies. Deemed Project Facilitate, the pilot program was announced at a press briefing during the 2019 ASCO Annual Meeting. Project Facilitate is essentially ...
FDA Pipeline: Applications Accepted in Gynecologic Cancers, Targeted Therapies
Recently, the U.S. Food and Drug Administration (FDA) accepted a new drug application for niraparib in the treatment of certain pretreated gynecologic cancers; granted Fast Track designation to a T-cell product; accepted investigational new drug applications for a myelopreservation agent and an...
FDA Approves Bevacizumab Biosimilar for Five Cancer Types
On June 28, the U.S. Food and Drug Administration (FDA) approved bevacizumab-bvzr (Zirabev), a biosimilar to bevacizumab (Avastin), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent, or metastatic nonsquamous non–small cell ...
FDA Approves Daratumumab in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed, Transplant-Ineligible Patients With Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The application received approval ...
Accelerated Approval Program: For the Benefit of Patients
A DIAGNOSIS of any life-threatening cancer or other serious illness has always been a world-shaking event for those touched by significant disease, and most of us have known—or will know—the frustration, helplessness, and desperate sense of urgency provoked by the words, “The disease is worsening,...
Trainee and Early-Career Members: Tips for Maximizing Your Benefit From ASCO Membership
ASCO is one of the premier professional societies that is guiding oncologists throughout the world. Whether you are a medical student or an early-career oncologist, ASCO has a lot to offer. A main focus of ASCO is to promote and provide guidance to trainees and early-career oncologists. I consider...
Register Early for ASCO’s Research Community Forum 2019 Annual Meeting
EARLY REGISTRATION is now open for the ASCO Research Community Forum (RCF) 2019 Annual Meeting. The ASCO RCF Annual Meeting brings together physician investigators and research staff from across the country for 2 days of learning and collaboration. The meeting offers colleagues from a variety of...
Improved Survival Shown With First-Line Pembrolizumab in Advanced Head and Neck Cancer
In the final analysis of KEYNOTE-048, first-line pembrolizumab monotherapy led to a significant improvement in overall survival, vs standard chemotherapy with targeted therapy (EXTREME regimen), in patients with recurrent or metastatic head and neck squamous cell carcinoma expressing programmed...
FDA Approves Pembrolizumab for the First-Line Treatment of Head and Neck Squamous Cell Carcinoma
On June 10, the U.S. Food and Drug Administration (FDA) approved the anti–programmed cell death protein 1 immunotherapy pembrolizumab (Keytruda) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma. Pembrolizumab was approved for...
FDA Announces Project Facilitate to Access Investigational Therapies for Patients With Cancer
The Oncology Center of Excellence of the U.S. Food and Drug Administration (FDA) recently announced a new pilot program to assist oncology health-care professionals in requesting access to unapproved therapies for patients with cancer. A new call center designated Project Facilitate will be a...
Darolutamide in Nonmetastatic Castration-Resistant Prostate Cancer: Delaying Overt Metastatic Disease Is a Major Advance
Nonmetastatic (M0) castration-resistant prostate cancer arises in the subset of men with biochemically recurrent disease (ie, rising prostate-specific antigen [PSA] level after definitive therapy in the absence of metastases) who develop PSA progression after chronic exposure to...
2019 ASCO: Resection of Liver Metastases
In this episode, we discuss more news from the ASCO Annual Meeting, including findings from a study with relevance to surgical oncology, a summary of a study in HER2-positive breast cancer, and a third study on discrimination among hematology/oncology fellows. We also discuss two FDA approvals that ...
FDA Expands Indications for Pembrolizumab to Include Metastatic SCLC With Disease Progression on or After Other Therapies
On June 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the anti–programmed cell death protein 1 (PD-1) therapy pembrolizumab (Keytruda) as monotherapy for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease...
FDA Approves New Trastuzumab Biosimilar
Today, the U.S. Food and Drug Administration (FDA) approved trastuzumab-anns (Kanjinti) for all approved indications of the reference product trastuzumab (Herceptin): for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal...
FDA Pipeline: Designations and Reviews in Myelofibrosis, Myelodysplastic Syndromes, Biliary Tract Cancer, and T-Cell Receptor Therapy
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for momelotinib in myelofibrosis, granted Priority Review to a biologics license application for luspatercept in myelodyslastic syndromes and beta-thalassemia, granted Orphan Drug designation for a new chemical...
2019 ASCO: Pancreatic, Urothelial, and Cervical Cancers
In this episode, we discuss more news from the ASCO Annual Meeting, sharing interviews with experts on studies in pancreatic, urothelial, and cervical cancers. We’ll also tell you about a couple of new drug approvals announced this week by the FDA.
Hani M. Babiker, MD, on Tumor Treating Fields: A Different Approach to Therapy
Hani M. Babiker, MD, of the The University of Arizona, discusses an emerging treatment that inhibits the mitotic spindle and disrupts tumor cell growth. The method has been approved by the FDA to treat some cancers and data show improved progression-free and overall survival (Abstracts 2055, 8551,...
FDA Approves Pembrolizumab for the First-Line Treatment of Head and Neck Squamous Cell Carcinoma
On June 10, the U.S. Food and Drug Administration (FDA) approved the anti–programmed cell death protein 1 immunotherapy pembrolizumab (Keytruda) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma. Pembrolizumab was...
FDA Approves Polatuzumab Vedotin-piiq in Combination With Bendamustine and a Rituximab Product for DLBCL
On June 10, the U.S. Food and Drug Administration (FDA) granted accelerated approval to polatuzumab vedotin-piiq (Polivy), a CD79b-directed antibody-drug conjugate, in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma...
Selected Abstracts From the 2019 ASCO Annual Meeting
To complement The ASCO Post’s comprehensive coverage of the 2019 ASCO Annual Meeting, here are several abstracts selected from the meeting proceedings focusing on novel therapeutic regimens for plasma cell dyscrasias, particularly multiple myeloma. For full details of these study abstracts, visit ...
FDA Pipeline: Reviews and Designations in Multiple Myeloma, Lymphoma, Prostate Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review for daratumumab in combination with a triplet therapy in multiple myeloma, Breakthrough Therapy designation to copanlisib for marginal zone lymphoma, and Fast Track designation for ARV-110 in metastatic...
Selected Studies From the 2019 ASCO Annual Meeting
In this debut episode of The ASCO Post Podcast, experts in breast, prostate, and lung cancers and multiple myeloma provide clinical insights about selected studies presented at the recent ASCO Annual Meeting, plus news from the FDA.
Ruxolitinib Approved for Acute Graft-vs-Host Disease
On May 24, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Jakafi) for steroid-refractory acute graft-vs-host disease (GVHD) in adult and pediatric patients 12 years and older. Approval was based on the REACH1 trial/Study INCB 18424-271, an open-label, single-arm, multicenter...
NovoTTF-100L System in Combination With Chemotherapy Approved for Malignant Pleural Mesothelioma
On May 23, the U.S. Food and Drug Administration (FDA) approved the NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable locally advanced or metastatic malignant pleural mesothelioma. NovoTTF-100L is a noninvasive,...
Alpelisib Plus Fulvestrant Approved for PIK3CA-Mutated Breast Cancer
On May 24, the U.S. Food and Drug Administration (FDA) approved the PIK3CA inhibitor alpelisib (Piqray) tablets to be used in combination with the FDA-approved endocrine therapy fulvestrant to treat postmenopausal women and men with hormone receptor–positive, HER2-negative, PIK3CA-mutated, advanced ...
How Have We Got It So Wrong?
The past 20 years have seen an unprecedented increase in the development of effective drugs for the management of cancer. The advent of immunotherapy offers even the promise of cure for some previously highly resistant diseases. The science is brilliant, the need is ever increasing—but the cost is ...
Richard Pazdur, MD, on the Launch of Project Facilitate
Richard Pazdur, MD, Director of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence and Acting Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, discusses the launch of Project Facilitate, a new pilot program to...
FDA Announces Project Facilitate
Today, the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence announced a new pilot program to assist oncology health-care professionals in requesting access to unapproved therapies for patients with cancer. A new call center designated Project Facilitate will be a single point...
FDA Approves Addition of Survival Data to Gilteritinib Label for Refractory FLT3-Mutated AML
On May 29, the U.S. Food and Drug Administration (FDA) approved the addition of overall survival data in the labeling for gilteritinib (Xospata), which is indicated for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation as detected by an FDA-approved...
Median Lag Time for First-in-Human to First-in-Child Oncology Trials
Cancer drugs approved by the U.S. Food and Drug Administration (FDA) took a median of 6.5 years to advance from the first clinical trial in adults to the first trial in children, according to a study published by Neel et al in the European Journal of Cancer. “Despite knowing that these...
FDA Oncology Drug Approvals Granted Between May 21, 2018 and May 14, 2019
Over the past year (May 2018–May 2019), the U.S. Food and Drug Administration (FDA) granted approval and accelerated approval to a number of new oncology drugs and biosimilars. Here we list the new FDA-approved labels and indications. AVELUMAB (BAVENCIO) and AXITINIB (INLYTA) has been approved as a ...
FDA Approves Lenalidomide in Combination for Previously Treated Follicular and Marginal Zone Lymphomas
Today, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid) in combination with a rituximab product for previously treated follicular and marginal zone lymphoma. AUGMENT and MAGNIFY Trials Approval was based on two clinical trials: AUGMENT and MAGNIFY. In AUGMENT, 358...
FDA Approves Alpelisib in Combination With Fulvestrant for PIK3CA-Mutated, Hormone Receptor–Positive Advanced Breast Cancer
On May 24, the U.S. Food and Drug Administration (FDA) approved alpelisib (Piqray) tablets to be used in combination with the FDA-approved endocrine therapy fulvestrant to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2...
FDA Approves the NovoTTF-100L System in Combination With Chemotherapy for Malignant Pleural Mesothelioma
On May 23, the U.S. Food and Drug Administration (FDA) approved the NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable locally advanced or metastatic malignant pleural mesothelioma. NovoTTF-100L is a noninvasive,...
FDA Approves Ruxolitinib for Acute Graft-vs-Host Disease
On May 24, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Jakafi) for steroid-refractory acute graft-vs-host disease (GVHD) in adult and pediatric patients 12 years and older. REACH1/Study INCB 18424-271 Approval was based on the REACH1 trial/Study INCB 18424-271, an...
Emily Whitehead, Early Recipient of CAR T-Cell Therapy for ALL, Celebrates 7 Years Cancer-Free
Among the success stories in the treatment of acute lymphoblastic leukemia (ALL) in children and young adults is the development of chimeric antigen receptor (CAR) T-cell therapy. The field of cellular immunotherapy was still in its infancy in 2012 when Emily Whitehead, then 7, became the first...
FDA Approves Ramucirumab for Hepatocellular Carcinoma
ON MAY 10, the U.S. Food and Drug Administration (FDA) approved ramucirumab (Cyramza) as a single agent for hepatocellular carcinoma in patients who have an alpha fetoprotein (AFP) level ≥ 400 ng/mL and have been previously treated with sorafenib. REACH-2 Trial APPROVAL WAS based on the REACH-2...
Capsaicin
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. In this installment, Shelly Latte-Naor, MD, and Jyothirmai Gubili, MS, explore the use of...
Erdafitinib for Metastatic Urothelial Carcinoma
On April 12, 2019, erdafitinib was granted accelerated approval for patients with locally advanced or metastatic urothelial carcinoma with susceptible fibroblast growth factor receptor 3 (FGFR3) or FGFR2 genetic alterations, when the disease has progressed during or following platinum-containing...
FDA Approves Chemotherapy-Free Regimen, Venetoclax Plus Obinutuzumab, as First-Line Treatment for CLL/SLL
On May 15, the U.S. Food and Drug Administration (FDA) approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Approval was based on the CLL14...
FDA Expands Pembrolizumab Indication for NSCLC in First-Line Setting
On April 14, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or those with metastatic NSCLC....
FDA Approves First-Line Ivosidenib for IDH1-Mutated AML
On May 2, the U.S. Food and Drug Administration (FDA) expanded its approval of ivosidenib (Tibsovo) to include newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that ...
Prolonged Exposure to Ibrutinib May Increase Effectiveness of CAR T-Cell Therapy in Patients With CLL
Chimeric antigen receptor (CAR) T-cell therapy has shown remarkable efficacy in the treatment of certain hematologic malignancies, including several types of large B-cell non-Hodgkin lymphomas (NHLs) and acute lymphoblastic leukemia (ALL). The U.S. Food and Drug Administration (FDA) has approved...
Introducing CancerLinQ® 2.0 and a New Era in Precision Oncology
In just 5 years since its launch in 2014, CancerLinQ®, ASCO’s big-data, rapid-learning, health information technology platform, has grown from 37 vanguard oncology practices to 58 participating practices in 2016 to 100 diverse oncology practices nationwide this year. CancerLinQ...
Researchers Supported by Conquer Cancer, the ASCO Foundation, Earn Spot in Clinical Cancer Advances 2019
The work of nine researchers who have previously received funding from Conquer Cancer is featured in ASCO’s Clinical Cancer Advances 2019. Visit CONQUER.ORG/CCA for more details. In two separate trials, Conquer Cancer–supported investigators produced research results that improved treatment for...
FDA Approves Avelumab/Axitinib Combination for Advanced Renal Cell Carcinoma
On May 14, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio) in combination with axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti–programmed cell death ligand 1 (PD-L1) therapy as...
FDA Approves T-DM1 for HER2-Positive Early Breast Cancer
On May 3, the U.S. Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (T-DM1; Kadcyla) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane- and trastuzumab-based treatment. Patients should be...
2019 Updates to NCCN Clinical Practice Guidelines in Genitourinary Oncology
The 24th Annual Conference of the National Comprehensive Cancer Network® (NCCN®) was held this past March in Orlando, Florida. Updates to a number of Clinical Practice Guidelines (NCCN Guidelines®) were reported, including three relevant to the field of genitourinary oncology: kidney cancer,...
