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Showing 2201 - 2250FDA Approves Gemtuzumab Ozogamicin for Treatment of Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) today approved gemtuzumab ozogamicin (Mylotarg) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen. The drug was also approved for the treatment of patients aged 2 years and older with...
FDA Statement Regarding Safety Concerns Related to Investigational Use of Pembrolizumab in Multiple Myeloma
On August 31, U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research Director Janet Woodcock, MD, issued the following statement: “Clinical trials play a critically important role in bringing to market innovative new therapies for patients facing life-threatening...
FDA Approves First CAR T-Cell Therapy for Pediatric and Young Adult Patients With B-Cell Precursor ALL
Today, the U.S. Food and Drug Administration (FDA) issued what it has called a “historic action,” making the first gene therapy available in the United States. The FDA approved tisagenlecleucel (Kymriah) for certain pediatric and young adult patients with a form of acute lymphoblastic...
FDA Grants Breakthrough Therapy Designation to DS-8201 for HER2-Positive Metastatic Breast Cancer
On August 29, Daiichi Sankyo announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to DS-8201, an investigational HER2-targeting antibody-drug conjugate, for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer...
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...
Reagan-Udall Foundation for the FDA Launches Expanded Access Navigator Website
THE NONPROFIT Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA) has released a new online resource called the Expanded Access Navigator. The website, which focuses on oncology, features the first pharmaceutical company directory of expanded access policies and criteria, as...
Pursuing Combination Strategies With Checkpoint and Tyrosine Kinase Inhibitors in Hepatocellular Carcinoma
PRIMARY LIVER CANCER is the second leading cause of cancer-related death worldwide. Hepatocellular carcinoma accounts for 90% of liver cancer, with around 800,000 new cases diagnosed globally each year.1 In contrast to the stable or declining trends observed for most neoplasms, the incidence and...
New ASCO Recommendations for Controlling Nausea and Vomiting Related to Cancer Treatment
AN UPDATE of the ASCO Clinical Practice Guideline covers new medicines for nausea and vomiting related to cancer treatment. The update, issued by Hesketh et al in the Journal of Clinical Oncology,1 provides new evidence-based information on the appropriate use of olanzapine, neurokinin 1 (NK1)...
International Consensus (or Not) on Management of Advanced Prostate Cancer
ALTHOUGH THE National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) strongly influence the management of advanced prostate cancer, they do not always reflect actual clinical practice. It turns out that in the real world, there are multiple areas ...
Fighting Misinformation in HPV-Related Cancer Prevention
FAKE NEWS, junk science, and alternative facts seem pervasive in our current culture, to the detriment of important, verified scientific advancements. One area where this is quite evident is the vaccine against human papillomavirus (HPV). Although we have had a safe, effective vaccine since 2006...
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...
FDA Approves Inotuzumab Ozogamicin for Relapsed or Refractory B-Cell Precursor ALL
On August 17, 2017, the U.S. Food and Drug Administration (FDA) approved inotuzumab ozogamicin (Besponsa) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). INO-VATE ALL The approval was based on data from INO-VATE ALL, a randomized (1:1), ...
Look for Opportunities to Lower Barriers to Participation of Older Patients in Oncology Clinical Trials
Practicing evidence-based medicine requires evidence, but the evidence for efficacy and safety of new and evolving cancer therapies in older adults is wanting due to their underrepresentation in oncology clinical trials. “It is difficult to practice evidence-based medicine in an older population...
‘Slow, Incremental Changes’ Are Increasing Participation of Older Adults in Clinical Trials
Older adults continue to be proportionally underrepresented in oncology clinical trials, but the participation rate of adults aged 65 and older is increasing by “slow, incremental changes,” Stuart M. Lichtman, MD, FACP, FASCO, noted in an interview with The ASCO Post. Prompting those changes are...
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...
Unraveling the Complexities of Cellular Immunotherapy and Its Potential to Cure Some Cancers
This past fall, the Fred Hutchinson Cancer Research Center in Seattle opened an all-encompassing 9,222-square foot outpatient cellular immunotherapy clinic, specifically designed to serve patients participating in the center’s novel immunotherapy clinical trials, which mainly focus on chimeric...
Triple-Negative Breast Cancer: Practical Approach, Promising Research
Triple-negative breast cancer has a reputation for being a particularly challenging malignancy, but breast cancer specialist Nancy Davidson, MD, Senior Vice President of the Clinical Research Division at the Fred Hutchinson Cancer Research Center, Seattle, put this in perspective in a recent...
FDA to Expand Public Education Campaign to Focus on Prevention of Youth E-Cigarette Use
On August 8, the U.S. Food and Drug Administration (FDA) announced it would pursue a strategic, new public health education campaign aimed at discouraging the use of e-cigarettes and other electronic nicotine delivery systems (ENDS) by children. The agency plans to expand its “The Real...
Senate Passes the RACE for Children Act
On August 3, the leadership of Kids v Cancer, an advocacy group promoting pediatric cancer research, issued the following statement: Today, the U.S. Senate passed the FDA Reauthorization Act and with it, the RACE for Children Act. Now, new cancer drugs will be developed not only for...
ASCO Tackles the Issue of the High Cost of Cancer Drugs
In July, ASCO issued a comprehensive set of recommendations to remedy the problem of escalating drug pricing on cancer therapies.1 ASCO’s position statement comes at a time when new cancer drugs are routinely priced at $100,000 a year or more—imatinib (Gleevec) costs up to $146,000 a year2—causing...
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...
FDA Announces Comprehensive Regulatory Plan to Shift Trajectory of Tobacco-Related Disease, Death
On July 28, the U.S. Food and Drug Administration (FDA) announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multiyear roadmap to better protect children and significantly reduce tobacco-related disease and death. The approach places nicotine and the issue of...
Financial Toxicity: Cancer Supportive Care Professionals Consider the Side Effects of Soaring Costs
IS IT POSSIBLE to identify patients with cancer who are at risk for financial stress and intervene to reduce that risk? And could reducing financial stress—or financial toxicity, as it is often called in the context of cancer care—improve both health-related quality of life and physical health?...
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...
FDA Expands Ibrutinib Indications to Chronic Graft-vs-Host Disease
On August 2, 2017, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica) for the treatment of adult patients with chronic graft-vs-host disease after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of chronic...
FDA’s First Site-Agnostic Drug Approval Marks a Paradigm Shift in Regulatory Criteria
IN MAY, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with solid tumors that have the microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) biomarker, which disrupts the ability of cells to repair DNA. The...
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...
FDA Approves Enasidenib in Relapsed or Refractory Acute Myeloid Leukemia
Today, the U.S. Food and Drug Administration (FDA) approved enasidenib (Idhifa) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which ...
FDA Grants Acalabrutinib Breakthrough Therapy Designation for the Treatment of Mantle Cell Lymphoma
Today, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Acalabrutinib is a highly selective, potent Bruton tyrosine kinase (BTK)...
FDA Approves Nivolumab in MSI-H or dMMR Metastatic Colorectal Cancer
Today, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) injection for intravenous use for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer...
New ASCO Recommendations for Controlling Nausea and Vomiting Related to Cancer Treatment
An update of the ASCO Clinical Practice Guideline covers new medicines for nausea and vomiting related to cancer treatment. The update, issued by Hesketh et al in the Journal of Clinical Oncology today, provides new evidence-based information on the appropriate use of olanzapine, neurokinin 1...
FDA Grants Venetoclax Breakthrough Therapy Designation for Geriatric Patients With Acute Myeloid Leukemia
On July 28, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for venetoclax (Venclexta) in combination with low-dose cytarabine for elderly patients with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. FDA...
FDA Grants Durvalumab Breakthrough Therapy Designation for Patients With Locally Advanced Unresectable NSCLC
On July 31, AstraZeneca and MedImmune (AstraZeneca’s global biologics research and development arm) announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for durvalumab (Imfinzi) for the treatment of patients with locally advanced,...
FDA Expands Approval of Ipilimumab to Include Pediatric Patients 12 Years and Older With Unresectable or Metastatic Melanoma
Today, the U.S. Food and Drug Administration (FDA) expanded the indication for ipilimumab (Yervoy) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Ipilimumab was evaluated in 2 trials of pediatric...
ASCO-AACI’s Best Practices in Cancer Clinical Trials Initiative: Streamlining Adverse Events Reporting and Research Community Forum Activities
Research sites and investigators face an ever-increasing number of challenges in the conduct and management of cancer clinical trials. Many of these challenges stem from the multitude of requirements for clinical trials that sponsors and regulatory and administrative agencies have set. In...
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...
ASCO Offers Path to Addressing Affordability of Cancer Drugs in New Position Statement
Today, ASCO issued a position statement aimed at contributing to the national dialogue on rising cancer drug prices. The statement, which asserts that any solutions must also preserve patients' access to care and foster innovation, analyzes a wide array of options and recommends that a panel of...
FDA Approves Three-Drug Combination Tablet for Hepatitis C
On July 18, the U.S. Food and Drug Administration (FDA) approved a combination tablet (Vosevi) to treat adults with chronic hepatitis C virus genotypes 1–6 without cirrhosis or with mild cirrhosis. This fixed-dose, combination tablet contains two previously approved drugs—sofosbuvir and ...
Spark Discussions About Indoor-Tanning Devices
“Strong evidence suggests that using a tanning bed during adolescence or young adulthood can increase the risk of early-onset melanoma by over 40%,” Jeffrey E. Gershenwald, MD, wrote in an opinion piece for Newsweek.1 Dr. Gershenwald is Professor of Surgical Oncology, Medical Director of the...
Educating Young People on Sun-Safe Behaviors and Reducing the Risk of Melanoma
“If minors don’t tan, then they may never become adult tanners,” Jeffrey E. Gershenwald, MD, said in explaining the emphasis on teaching sun safety behaviors to young children as part of the Melanoma Moon Shot Program at The University of Texas MD Anderson Cancer Center, Houston. Dr. Gershenwald is ...
CDK4/6 Inhibitors Have a Manageable Toxicity Profile, Are Generally Well Tolerated in Patients With Breast Cancer
A class of oral drugs for treating breast cancer known as cyclin-dependent kinase (CDK) 4/6 inhibitors are generally well-tolerated, with a manageable toxicity profile for most patients. This is the conclusion of a comprehensive review of toxicities and drug interactions related to this class of...
The Immune System: Deciphering Recent Advances
Over the past decade, there has been renewed interest in developing immunologic therapies in cancer. The U.S. Food and Drug Administration (FDA) has approved several new biologic agents that target a patient’s immune system, some of which have produced profound clinical responses. However, the...
FDA Takes Action Against 14 Companies for Selling Illegal Cancer Treatments
On April 25, the U.S. Food and Drug Administration (FDA) posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat, or cure cancer. The products are marketed and sold without FDA approval, most commonly...
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...
FDA’s ODAC Unanimously Recommends Biosimilar Versions of Bevacizumab and Trastuzumab
On July 13, the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) unanimously recommended approval of biosimilar versions of bevacizumab (Avastin) and trastuzumab (Herceptin). In the morning session, ODAC members voted 17-0 in favor of approving Amgen's...
FDA’s Advisory Committee Supports CTL019 in Pediatric, Young Adult Patients With B-Cell ALL
Today, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) met to discuss the biologics license application (BLA) for the chimeric antigen receptor (CAR) T-cell therapy CTL019 (tisagenlecleucel) for the treatment of relapsed or refractory pediatric and young adult...
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...
