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Showing 2351 - 2400Recent FDA Actions Include New Formulation, Expanded Indications for Oncology-Hematology Drug Products
The U.S. Food and Drug Administration (FDA) recently granted approval to olaparib tablets (Lynparza) as a maintenance therapy for ovarian cancer and to inotuzumab ozogamicin (Besponsa), for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)....
Targeted Treatments and Health-Related Quality of Life in Ovarian Cancer
Novel targeted treatment strategies and new trial endpoints in recurrent, platinum-sensitive ovarian cancer were highlighted in a gynecologic cancer session at the Best of ASCO New Orleans. At the meeting, Karen McLean, MD, PhD, of the University of Michigan Medical Center, Ann Arbor, presented...
Long-Term Follow-up of PIVOT Argues for Immediate Treatment of Men With Unfavorable-Risk and Possibly High-Volume, Low-Risk Prostate Cancer
The updated results of the PIVOT1 study—reported in The New England Journal of Medicine by Wilt et al and reviewed in this issue of The ASCO Post—did not show a statistically significant difference between treatment and observation for the initial management approach to men with newly diagnosed...
Tivozanib Approved in the European Union for the Treatment of Advanced Renal Cell Carcinoma
On August 28, AVEO Oncology announced that the European Commission (EC) has approved tivozanib (Fotivda) for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland. Tivozanib is indicated for the first-line treatment of adult patients with...
Phase III ALCYONE Study of Daratumumab in Front-Line Treatment of Multiple Myeloma
On August 24, positive topline results were announced from the phase III ALCYONE study of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) vs VMP alone as front-line treatment for newly diagnosed patients who are not considered candidates for...
FDA Accepts sBLA, Grants Priority Review for Obinutuzumab in Previously Untreated Follicular Lymphoma
On August 28, the U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for obinutuzumab (Gazyva) in combination with chemotherapy followed by obinutuzumab alone for patients with previously untreated follicular lymphoma....
FDA Approves Fulvestrant as Monotherapy for Expanded Use in Breast Cancer
On August 28, the U.S. Food and Drug Administration (FDA) approved fulvestrant (Faslodex) at 500 mg as monotherapy for expanded use in women with hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer who have gone through menopause...
Cutting-Edge Induction Strategies and Novel Approach to Reducing Skeletal-Related Events Explored in Multiple Myeloma
THE ADDITION of daratumumab (Darzalex) to a triplet induction regimen led to good responses in newly diagnosed multiple myeloma, but not without toxicities. And in the treatment of myeloma bone disease, denosumab (Xgeva) in place of zoledronic acid preserved renal function and may be associated...
Updates of Key Trials in Metastatic Non–Small Cell Lung Cancer: KEYNOTE-024 and AvaALL
IMMUNOTHERAPY AND ANTIANGIOGENESIS were highlighted in a session on metastatic non–small cell lung cancer (NSCLC) at the Best of ASCO New Orleans meeting. Matthew Gubens, MD, MS, presented the selected abstracts from the ASCO Annual Meeting.1 Dr. Gubens is Associate Professor of Thoracic Medical...
FDA Approves Olaparib Tablets for Maintenance Treatment in Ovarian Cancer
On August 17, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib tablets (Lynparza) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to...
CheckMate-214: Nivolumab and Ipilimumab in Intermediate- and Poor-Risk Previously Untreated Advanced or Metastatic RCC
On August 15, Bristol-Myers Squibb Company announced topline results from the CheckMate-214 trial investigating nivolumab (Opdivo) in combination with ipilimumab (Yervoy) vs sunitinib (Sutent) in intermediate- and poor-risk patients with previously untreated advanced or metastatic renal cell...
FDA Accepts sBLA and Grants Priority Review for Brentuximab Vedotin in Cutaneous T-Cell Lymphoma
On August 16, the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for brentuximab vedotin (Adcetris) in patients with cutaneous T-cell lymphoma (CTCL). The sBLA and its acceptance is based on data from the phase III...
Recent FDA Actions Include New Drug Approvals in Leukemia, Expanded Approvals in Colorectal Cancer and Graft-vs-Host Disease
The U.S. Food and Drug Administration (FDA) recently granted approval, expanded approval, and breakthrough therapy designation to numerous treatments across a range of tumor types and malignancies. New Drug Approvals Daunorubicin-Cytarabine Combination (Vyxeos): On August 3, the FDA granted...
Turmeric
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, Gary Deng, MD, PhD, and Jyothirmai Gubili, MS, present information on...
Lung Cancer Clinical Trial Eligibility Criteria Increase in Number, Complexity
With the advent of molecular targeted therapies and immunotherapy, eligibility criteria have increased in number and complexity for lung cancer clinical trials, according to an analysis published by Garcia et al in the Journal of Thoracic Oncology. Despite calls to streamline cancer clinical trial...
Blinatumomab in Advanced Acute Lymphoblastic Leukemia: A Brighter Therapeutic Outlook
NEW DRUGS that will improve the outcome of adult patients who develop a deadly disease such as acute leukemia are badly needed; combinations of cytotoxic chemotherapeutic drugs may have reached an upper limit of utility. Agents that eradicate leukemia by alternative mechanisms would be of...
FDA Approves Liposome-Encapsulated Combination of Daunorubicin-Cytarabine for Some Types of Poor-Prognosis AML
On August 3, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos) for the treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related...
FDA Grants Alectinib Priority Review for Initial Treatment of ALK-Positive Lung Cancer
Today, the U.S. Food and Drug Administration (FDA) accepted Genentech’s supplemental New Drug Application (sNDA) and granted Priority Review for alectinib (Alecensa) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced, or metastatic...
How to Help Young Patients Preserve Their Fertility
GUEST EDITOR Adolescent and Young Adult Oncology explores the unique physical, psychosocial, social, emotional, sexual, and financial challenges adolescents and young adults with cancer face. The column is guest edited by Brandon Hayes-Lattin, MD, FACP, Professor of Medicine and Medical Director...
Advances in the Treatment of Triple-Negative Breast Cancer
WITHIN THE SPECTRUM of breast cancer subtypes, triple-negative disease is “particularly troubling,” but better scientific understanding of this malignancy is leading to advances in its treatment, according to breast cancer expert Nancy Davidson, MD. Triple-negative breast cancer does not express...
New Data Reported on Vemurafenib, Vitamin D, Selective Internal Radiotherapy, and Circulating Tumor DNA in Colorectal Cancer
RESULTS OF the IDEA trial, which showed that some patients with stage III low-risk colon cancer may require less oxaliplatin therapy (see the June 25 issue of The ASCO Post), were among the findings highlighted at the 2017 ASCO Annual Meeting Plenary Session. Other studies of interest in colorectal ...
More Support for FOLFOXIRI/Bevacizumab in Advanced Colorectal Cancer
A RANDOMIZED head-to-head comparison in patients with advanced colorectal cancer found that a regimen of FOLFOXIRI (fluorouracil/leucovorin, oxaliplatin, irinotecan) plus bevacizumab (Avastin) was more effective than a regimen of FOLFOX (fluorouracil/leucovorin, oxaliplatin) plus bevacizumab as...
FDA Actions Yield Extended Approvals of Novel Agents, Advisory Committee Votes Favorably on Two Biosimilars and Pediatric Indication for CAR T-Cell Therapy
DURING JULY, the U.S. Food and Drug Administration (FDA) and its Oncologic Drugs Advisory Committee (ODAC) made a number of approvals and recommendations on a variety of oncology products. Neratinib ON JULY 1 7, the FDA approved neratinib (Nerlynx) for the extended adjuvant treatment of adult...
In Case You Missed It: Short Takes on Current Cancer Research
MOST ONCOLOGISTS are familiar with the findings of the plenary sessions featured at the 2017 ASCO Annual Meeting, with topics ranging from the duration of adjuvant oxaliplatin-based therapy in stage III colon cancer to patient-reported outcomes for symptom monitoring during routine cancer...
Tissue Specimens in Clinical Trials: A Double-Edged Sword
AN INCREASING number of clinical trials require the submission of tissue specimens, either from archived specimens or increasingly from fresh biopsies taken after enrollment into the trial. These specimens can be either mandatory, required to determine whether a given patient has the required...
A New Triumvirate in Estrogen Receptor–Positive Metastatic Breast Cancer
THE BODY OF EVIDENCE supporting the use of cell-cycle inhibitors in combination with endocrine therapy for estrogen receptor–positive metastatic breast cancer now has another agent in the spotlight. The phase III MONARCH 2 trial—reported at the 2017 ASCO Annual Meeting and by Sledge et al in the...
Fulvestrant Receives EC Approval as First-Line Therapy for Advanced Breast Cancer
On July 26, the European Commission (EC) approved fulvestrant (Falsodex) for the treatment of estrogen receptor–positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy. The EC approval is based on pivotal data from the...
Khurshid Guru, MD, Named Chair of Urology at Roswell Park
KHURSHID GURU, MD, an acclaimed robotic surgeon, has been named Chair of the Department of Urology at Roswell Park Cancer Institute. Dr. Guru, who was recruited to Roswell Park in 2005 to direct the Institute’s robotic surgery program, will lead a team of more than 50 faculty members, clinicians,...
Pembrolizumab and Cetuximab-Treated Head and Neck Cancer: Activity Confirmed But No Surprises
WITH THE RECENT efficacy findings, improvements in survival, and resultant U.S. Food and Drug Administration (FDA) approvals of programmed cell death protein 1 (PD-1) immune checkpoint inhibitors across multiple solid tumor indications, the publication of yet another positive trial adds to the...
Pembrolizumab in Second-Line Therapy for Advanced Urothelial Carcinoma
THE TREATMENT OF metastatic urothelial carcinoma experienced a long period of stagnation until the recognition that targeting the programmed cell death protein 1 (PD-1) pathway could yield deep and durable responses.1-3 Cisplatin-based combination chemotherapy has been the reference standard for...
Study Supports Omission of Lymphadenectomy in Node-Negative Advanced Ovarian Cancer
SYSTEMATIC LYMPHADENECTOMY in patients with advanced ovarian cancer and complete resection offered no improvement in progression-free or overall survival in the Gynecologic Cancer Intergroup’s LION trial, reported at the 2017 ASCO Annual Meeting by Philipp Harter, MD, PhD, of the German...
Expert Point of View: Steven J. Cohen, MD, and Josep Tabarnero, MD, PhD
STEVEN J. COHEN, MD, Director of the Rosenfeld Cancer Center at Jefferson Health/Abington Hospital, Abington, Pennsylvania, and Vice Chair of Medical Oncology at Sidney Kimmel Cancer Center at Jefferson, and Josep Tabernero, MD, PhD, Head of Medical Oncology and the Gastrointestinal Tumors and...
Tumor ‘Sidedness’ in Colon Cancer: Studies Look for Explanations
TUMOR “SIDEDNESS” in colon cancer has become a topic of great interest, after right-sided tumors were shown to have a worse prognosis than left-sided ones and biologics were found to differ in efficacy based on side. At the 2017 ASCO Annual Meeting, studies explored why this might be so. Three...
Radiation Therapy for Spinal Cord Compression: One Treatment Is Sufficient
SPINAL CORD COMPRESSION associated with metastatic cancer can be effectively treated with a single dose of radiotherapy, according to the results of a phase III British study that showed multiple radiotherapy doses to be no better than one treatment.1 Up to 10% of all patients with cancer will...
Music Therapy: Relevance in Oncology
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, authors Karen Popkin, LCAT, MT-BC, and Jyothirmai Gubili, MS, present the case ...
Advance Care Planning: Ensuring Patients’ End-of-Life Wishes Are Honored
When Amy Berman, BSN, LHD (aged 58), stood in front of the mirror to perform a routine breast self-exam and saw redness and dimpling on her right breast, she feared they were the telltale signs of inflammatory breast cancer. “I have never self-diagnosed myself before, but I had recently read an...
Adding Pravastatin to Chemotherapy in Small Cell Lung Cancer
Following early reports associating favorable outcomes in cancer patients with the use of statins,1,2 further observational studies in this area have provided mixed findings.3 As recently reported in the Journal of Clinical Oncology, and reviewed in this issue of The ASCO Post, Seckl and colleagues ...
FDA Approves Neratinib for Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer
Today, the U.S. Food and Drug Administration approved neratinib (Nerlynx) for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab (Herceptin)-based therapy. ExteNET Trial Approval was based on the ExteNET...
Blinatumomab Granted Full Approval to Treat Relapsed or Refractory B-cell Precursor ALL in Adults and Children
On July 11, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for blinatumomab (Blincyto) to include overall survival data from the phase III TOWER study. The approval converts blinatumomab's accelerated approval to a full approval. The sBLA...
Narrow Network Insurance Plans More Likely to Exclude Doctors at NCI-Designated and NCCN Member Cancer Centers
Patients with cancer in the United States may be unable to access care at the nation’s top hospitals due to narrow insurance plan coverage—leaving patients to choose between lower premiums or access to higher-quality cancer care. A new study from the Perelman School of Medicine at the...
Has a New Standard Really Been Established for the Adjuvant Treatment of Pancreatic Cancer?
THE PAST YEAR has undoubtedly been a disappointing one as far as clinical advances in pancreatic cancer go. No fewer than five high-profile randomized phase II or III trials in this setting reported negative results in 2016, ranging from next-generation cytotoxic agents1 to novel immunotherapeutic ...
Encouraging Results With Pembrolizumab in Relapsed/Refractory Classical Hodgkin Lymphoma
AN EFFECTIVE antitumor immune response relies on cytotoxic T cells that are activated and able to target the malignant clone. As T cells become activated, they upregulate suppressive receptors including programmed cell death protein 1 (PD-1). Upregulation of inhibitory signals is important to...
Retreatment With Checkpoint Inhibitors May Be Feasible for Some Patients With NSCLC
INCREASING NUMBERS of patients are being treated with checkpoint inhibitors, and about one-quarter to one-third will develop immune-related adverse events. One question on the minds of oncologists is can these patients be safely re-treated once their adverse events resolve? One of the first...
Dacomitinib Outperforms Gefitinib in EGFR-Positive NSCLC
DACOMITINIB, a second-generation epidermal growth factor receptor (EGFR)-targeted tyrosine kinase inhibitor, outperformed gefitinib (Iressa) as first-line treatment for EGFR-positive advanced non–small cell lung cancer (NSCLC) in the phase III ARCHER 1050 study.1 Dacomitinib improved...
Ublituximab/Ibrutinib Beneficial in Patients With Chronic Lymphocytic Leukemia
The addition of ublituximab (a glycoengineered anti-CD20 antibody) to ibrutinib (Imbruvica) improved response rates, depth of response, and led to quicker resolution of ibrutinib-associated lymphocytosis in patients with high-risk chronic lymphocytic leukemia (CLL) in the phase III GENUINE trial,...
Pembrolizumab Moving Forward in Triple-Negative Breast Cancer
In the treatment of triple-negative breast cancer, checkpoint inhibition is making inroads in both early- and late-stage disease, and the line of treatment and expression of the programmed cell death ligand 1 (PD-L1) could be important in determining outcomes, according to studies reported at the...
FDA Approves Panitumumab for Use in Wild-Type RAS Metastatic Colorectal Cancer
On June 30, 2017, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for panitumumab (Vectibix) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic...
Scalp Cooling to Prevent Chemotherapy-Induced Alopecia: Is It Now Ready for Prime Time?
In oncology, sometimes we forget about the small, everyday things that can significantly impact a patient’s life. When patients are explained the side effects of chemotherapy and chemotherapy-induced alopecia, most women will cry or become visibly upset. When a woman loses her hair, it represents...
Two Studies Show Scalp Cooling Reduces Hair Loss in Women Receiving Chemotherapy for Breast Cancer
An interim analysis of the SCALP trial, reported in JAMA by Julie Nangia, MD, of Baylor College of Medicine, and colleagues, showed that use of a scalp-cooling device significantly reduced hair loss in women receiving chemotherapy for stage I or II breast cancer compared with no scalp cooling.1 The ...
Idelalisib in Resistant CLL: Benefit Shown, Questions Remain
As reported in The Lancet Oncology by Dr. Andrew Zelenetz and colleagues and reviewed in this issue of The ASCO Post, an international phase III trial in 416 patients with refractory or recurrent chronic lymphocytic leukemia (CLL) addressed the benefit of adding the first-in-class phosphoinositide...
