Search Results
Your search for The ASCO P matches 3763 pages
Showing 2251 - 2300FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly Diagnosed Philadelphia Chromosome–Positive CML
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif) for treatment of patients with newly diagnosed chronic-phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML). Approval was based on data from an open-label,...
American Association for the Advancement of Science Inducts New Fellows
The American Association for the Advancement of Science (AAAS) has recently inducted 396 members as fellows, with 21 members having oncology backgrounds. Members have been awarded this honor because of their scientifically or socially distinguished efforts to advance science or its applications....
Neratinib Is Approved: Should We Reject It Anyway?
The U.S. Food and Drug Administration (FDA) approved 1 year of extended adjuvant neratinib (Nerlynx) after chemotherapy and a year of trastuzumab (Herceptin) for HER2-positive breast cancer this summer on the basis of the ExteNET trial. Many were surprised at the approval, since the evidence of...
St. John’s Wort
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies commonly used by patients with cancer. In this installment, Jun J. Mao, MD, MSCE, and Jyothirmai Gubili, MS, explore the role of St....
FDA Grants Regular Approval to Pertuzumab for Adjuvant Treatment of HER2-Positive Breast Cancer
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. Approval was...
ASCO Resolutions Approved by AMA House of Delegates
From November 11–14, ASCO delegates participated in the American Medical Association’s (AMA) Interim Meeting of the House of Delegates (HOD), the principal policy-making body of the AMA. During the meeting, several ASCO-backed resolutions were approved, including: Medicare Part B Drugs in QPP/MIPS...
FDA Approves Cabozantinib for First-Line Treatment of Advanced Renal Cell Carcinoma
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular -approval to cabozantinib -(Cabometyx) for treatment of patients with advanced renal cell carcinoma (RCC). The FDA previously approved cabozantinib in 2016 for treatment of patients with advanced RCC who have...
Bosutinib for First-Line Use in Chronic Myeloid Leukemia: Is Three a Crowd?
BOSUTINIB ( BOSULIF) is the latest tyrosine kinase inhibitor that has shown a superior molecular response profile when compared with imatinib.1,2 An orally available dual SRC/ABL1 inhibitor, the drug was shown in preclinical studies to have a potent inhibitory activity against BCR-ABL1 and minimal ...
Reports From the Journal of Clinical Oncology
Immunotherapy in PD-L1–Positive Advanced Cervical Cancer Pembrolizumab (Keytruda) treatment was active in patients with programmed cell death ligand 1 (PD-L1)–positive advanced cervical cancer enrolled in the phase Ib KEYNOTE-028 trial. The findings were reported by Jean-Sebastien Frenel, MD, of...
Phase II Data for Venetoclax/Ibrutinib Combination in Relapsed or Refractory Chronic Lymphocytic Leukemia
THE COMBINATION of ibrutinib (Imbruvica) plus venetoclax (Venclexta) achieved favorable responses in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to initial results of the phase II CLARITY trial presented at the 2017 American Society of Hematology (ASH) Annual ...
Nivolumab for Adjuvant Treatment of Melanoma Granted Regular Approval by FDA
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to the anti–programmed cell death protein 1 (PD-1) monoclonal antibody nivolumab (Opdivo) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes, or in patients with...
FDA Grants Regular Approval to Pertuzumab for Adjuvant Treatment of HER2-Positive Breast Cancer
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. APHINITY...
FDA Approves Cabozantinib for First-Line Treatment of Advanced Renal Cell Carcinoma
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to cabozantinib (Cabometyx) for treatment of patients with advanced renal cell carcinoma (RCC). The FDA previously approved cabozantinib in 2016 for treatment of patients with advanced RCC who have received...
FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly Diagnosed Philadelphia Chromosome–Positive CML
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif) for treatment of patients with newly diagnosed chronic-phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML). BFORE Trial Approval was based on data from ...
Updated Data in KEYNOTE-061: Pembrolizumab in Previously Treated Gastric or Gastroesophageal Junction Adenocarcinoma
The phase III KEYNOTE-061 trial investigating pembrolizumab (Keytruda) as a second-line treatment for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma did not meet its primary endpoint of overall survival (OS) (hazard ratio [HR] = 0.82, 95% confidence interval [CI] = ...
ASH 2017: ALCANZA Trial: Brentuximab Vedotin in CD30-Expressing Cutaneous T-Cell Lymphoma
Updated results from the phase III ALCANZA clinical trial evaluating brentuximab vedotin (Adcetris) in CD30-expressing cutaneous T-cell lymphoma (CTCL) were presented by Horwitz et al at the 59th American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 1509). The presentation...
Carla Casulo, MD, on Follicular Lymphoma: Results From the FLASH Study
Carla Casulo, MD, of the James P. Wilmot Cancer Center, discusses findings on POD24 as a robust early clinical endpoint of poor survival in follicular lymphoma, using data from more than 5,000 patients in 13 clinical trials (Abstract 412).
SABCS 2017: Phase III EMBRACA Trial Meets Primary Endpoint
Patients with advanced HER2-negative breast cancer with germline BRCA mutations had significantly prolonged progression-free survival when treated with the poly(ADP-ribose) polymerase (PARP) inhibitor talazoparib, compared with those who received chemotherapy of physician’s choice, according...
SABCS 2017: Combined Residual Risk Score Test and Predicting Breast Cancer Risk in Women Who Tested Negative for Hereditary Mutations
Results from a validation study to better define the risk of breast cancer in women of European ancestry who tested negative for a hereditary cancer mutation with a hereditary cancer risk test (myRisk Hereditary Cancer test) were reported earlier this week in a spotlight presentation at the 2017...
Immunotherapy Has Indelibly Changed the Treatment Paradigm in Urothelial Carcinoma
Cisplatin-based combination chemotherapy is the preferred first-line therapy for metastatic urothelial cancer and the only treatment shown to improve survival in patients with previously untreated disease for many years. This chemotherapy also has proven to be beneficial in the neoadjuvant and...
Immunotherapy Plus Chemotherapy in Non–Small Cell Lung Cancer: Despite the Failure of Ipilimumab, Guarded Optimism Persists
Ipilimumab (Yervoy) is a fully human monoclonal antibody that inhibits cytotoxic T-lymphocyte–associated protein 4 (CTLA-4) and was the first checkpoint inhibitor approved after showing survival benefit in metastatic melanoma.1 Indeed, in the first-line setting for metastatic melanoma, ipilimumab ...
Follicular Lymphoma: Is the Road to Cure Paved With Gallium?
The roadside along the path to curing follicular lymphoma is riddled with the debris of failed cytotoxic regimens. For decades, clinical trials unsuccessfully pitted various chemotherapy combinations against each other. It took but a single, noncytotoxic molecule, rituximab (Rituxan), to forever...
Evidence-Based Support for Triplet Therapies in Multiple Myeloma
Over the past 15 years, multiple myeloma has garnered among the highest number of regulatory approvals by the U.S. Food and Drug Administration (FDA) for the management of all phases of the disease. This fast-expanding repertoire of treatment options has pushed the median survival of multiple...
FDA Grants Bevacizumab Full Approval in Recurrent Glioblastoma
On December 5, the U.S. Food and Drug Administration (FDA) granted full approval of bevacizumab (Avastin) for the treatment of adults with recurrent glioblastoma that has progressed following prior therapy. Bevacizumab was previously granted provisional approval in this setting under the FDA's ...
More Than One-Third of PAs in Oncology Experience Burnout, Despite High Rate of Career Satisfaction
A new physician assistant (PA)-based study finds that despite personal satisfaction in the oncology specialty, high rates of burnout—over one-third of PAs (34.8%)—are common. These findings reveal important factors that could help to decrease burnout and improve the oncology workforce...
FDA Approvals in November 2017: Novel Drugs, New Indications
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) approved a number of novel drugs and new indications in November 2017. Several of them are listed here. Fulvestrant/Abemaciclib Combination in Breast Cancer ON NOVEMBER 15 , the FDA approved fulvestrant (Faslodex) in combination with abemaciclib...
Reports From JCO and JOP
Staying up-to-date with peer-reviewed oncology literature is a daunting task. To assist readers, The ASCO Post has summarized a number of studies recently published in the Journal of Oncology Practice (JOP) and the Journal of Clinical Oncology (JCO). Survival as Quality Metric in Cancer Care In a...
Update on NCI-MATCH Precision Medicine Trial
THE NATIONAL CANCER INSTITUTE (NCI) Molecular Analysis for Therapy Choice (MATCH) clinical trial has achieved the goal of screening nearly 6,000 patients in just under 2 years, according to data presented at the 2017 American Association for Cancer Research–NCI–European Organisation for Research...
IDEA Trial: ‘Going Beyond Statistics’ in Stage III Colon Cancer
According to Alberto Sobrero, MD, Head of Medical Oncology at Ospedale San Martino in Genova, Italy, the results of the pivotal IDEA trial, which evaluated the optimal duration of adjuvant chemotherapy for stage III colon cancer, were not clear to clinicians.1 The combined analysis of six...
ASCO Election Candidates
SIXTEEN DISTINGUISHED ASCO members have been selected by the ASCO Nominating Committee as candidates for open leadership positions within the Society, including: The offices of President-Elect and Treasurer Four seats on the Society’s Board of Directors Two seats on the Nominating Committee...
ESMO Asia 2017: FLAURA Trial: Osimertinib Improves Progression-Free Survival in Asian Patients With EGFR-Mutated NSCLC
Osimertinib (Tagrisso) improves progression-free survival compared to standard first-line therapy in Asian patients with EGFR-mutated non–small cell lung cancer (NSCLC), according to the Asian subset analysis of the FLAURA trial presented at the European Society for Medical Oncology (ESMO)...
ESMO Asia 2017: AXEPT Trial: New Second-Line Therapy for Metastatic Colorectal Cancer Is Effective and Safe
A randomized trial in 650 patients has confirmed the safety and efficacy of a new second-line treatment for metastatic colorectal cancer, researchers reported at the European Society for Medical Oncology (ESMO) Asia 2017 Congress (Abstract LBA3_PR). Oral fluorinated pyrimidines have been...
Stand Up To Cancer Launches ‘Cancer Interception’ Teams to Detect and Treat Cancer at Earliest Stages
Stand Up To Cancer, joined by the Lustgarten Foundation for Pancreatic Cancer Research, LUNGevity, and the American Lung Association, announced that four teams of top researchers will study lung and pancreatic cancers using a new approach of “cancer interception” at their earliest stages. “The...
ESMO Asia 2017: Analysis of Mutations in Cerebrospinal Fluid in Lung Cancer With Brain Metastases
In a study presented at the European Society for Medical Oncology (ESMO) Asia 2017 Congress (Abstract 35P_PR), researchers analyzed the presence of mutations in the cerebrospinal fluid of patients with lung cancer and brain metastases. Tumor tissue from brain metastasis is difficult to obtain,...
Sequencing Therapy in Chronic Lymphocytic Leukemia
Although the indications to initiate treatment for chronic lymphocytic leukemia (CLL) have not changed, determining the optimal first-line treatment and sequence of therapies once treatment has begun remain challenges for providers. At the National Comprehensive Cancer Network® (NCCN®) 12th Annual...
FDA Approves Obinutuzumab for Previously Untreated Advanced Follicular Lymphoma
On November 16, Genentech announced that the U.S. Food and Drug Administration (FDA) approved obinutuzumab (Gazyva) in combination with chemotherapy, followed by obinutuzumab alone in those who responded, for people with previously untreated advanced follicular lymphoma (stage II bulky, III, or...
FDA Approves Fulvestrant in Combination With Abemaciclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Today, the U.S. Food and Drug Administration (FDA) approved a new indication for fulvestrant (Faslodex), expanding the drug's approved use to include combined therapy with abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4/6 inhibitor, for the treatment of hormone receptor–positive,...
FDA Approves Brentuximab Vedotin for Primary Cutaneous Anaplastic Large Cell Lymphoma
Today, the U.S. Food and Drug Administration (FDA) granted regular approval to brentuximab vedotin (Adcetris) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides who have received prior systemic therapy. ALCANZA...
FDA Approves Letermovir for Prophylaxis of Cytomegalovirus Infection and Disease in Allogeneic Stem Cell Transplant Patients
Today, the U.S. Food and Drug Administration (FDA) approved letermovir (Prevymis) once-daily tablets for oral use and injection for intravenous infusion. Letermovir is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic...
FDA Approves Intravenous Rolapitant for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting
ON OCTOBER 25, the U.S. Food and Drug Administration (FDA) approved intravenous (IV) rolapitant (Varubi) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including...
Balancing Immune-Related Adverse Events With Efficacy of Dual Checkpoint Inhibitor Therapy in Melanoma
MUCH PROGRESS has been made in the past decade in the treatment of patients with newly diagnosed metastatic melanoma. In the front-line setting, programmed cell death protein 1 (PD-1) monotherapy (nivolumab [Opdivo] and pembrolizumab [Keytruda]) and combined PD-1 plus cytotoxic...
Long-Term Survival Rates More Than Double Previous Estimates for Locally Advanced Lung Cancer
THE LONG-TERM RESULTS of a phase III clinical trial indicate that survival rates for patients receiving chemoradiation for unresectable, locally advanced non–small cell lung cancer (NSCLC) may be more than twice as high as previous estimates, setting a new benchmark of survival for patients with...
FDA Approves Alectinib for ALK-Positive Metastatic NSCLC
On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to alectinib (Alecensa) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC), as detected by an FDA-approved test. In December 2015,...
FDA Accepts sBLA for Bevacizumab as a Front-Line Treatment for Advanced Ovarian Cancer
On October 25, Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for bevacizumab (Avastin) in combination with chemotherapy (carboplatin and paclitaxel), followed by bevacizumab alone, for the front-line ...
International Trials Reveal New Findings in the Management of Breast and Ovarian Cancers
The European Society for Medical Oncology (ESMO) 2017 Congress, held in Madrid, featured important news including at least seven practice-changing or potentially practice-changing trials, which are covered in recent issues of The ASCO Post. Here we present additional highlights of studies in breast ...
Quick Takes on Studies in Noncolorectal Gastrointestinal Cancers
In this roundup, The ASCO Post offers a glance at key findings from studies in noncolorectal gastrointestinal malignancies presented at the European Society for Medical Oncology (ESMO) 2017 Congress from investigators around the world. Docetaxel-Based Triplet in Gastric Cancer The superiority of...
Model Emphasizes Long-Term Risks of Ovarian Ablation Plus Aromatase Inhibitor
“At Microphone 1” is an occasional column written by Steven E. Vogl, MD, of Bronx, New York. When he’s not in his clinic, Dr. Vogl can generally be found at major oncology meetings and often at the microphone, where he stands ready with critical questions for presenters of new data. Here Dr. Vogl...
ENDEAVOR Trial Endeavors to Make Case for Carfilzomib: Despite Survival Advantage, Should We Be Surprised?
LOCATION! LOCATION! LOCATION! That’s what home buyers are frequently cautioned about before purchasing a property. For trialists, and more importantly, practicing oncologists, a study’s design, akin to a property’s location, must be taken into account prior to buying into the results and changing ...
Adjuvant Dabrafenib/Trametinib Combination Granted FDA Breakthrough Therapy Designation for Stage III Melanoma With BRAF V600 Mutation
On October 23, Novartis announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following...
AACR-NCI-EORTC: NCI-MATCH Reaches Central Patient-Screening Goal
The National Cancer Institute (NCI) Molecular Analysis for Therapy Choice (MATCH) clinical trial has achieved the goal of screening nearly 6,000 patients in just under 2 years, according to data presented by Chen et al at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer...
