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Showing 2251 - 2300Financial 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...
FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple NSCLC Therapies
On June 22, the U.S. Food and Drug Administration (FDA) granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing–based test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non–small cell...
Priority Review Granted for Abemaciclib in the Treatment of Advanced Breast Cancer
On July 10, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for abemaciclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, and gave the NDA a Priority Review designation. The NDA includes Eli Lilly and Company’s submission of abemaciclib for two indications: ...
FDA Accepts sNDA for Dasatinib in Pediatric Patients With Philadelphia Chromosome–Positive Chronic-Phase CML
On July 10, the U.S. Food and Drug Administration (FDA) accepted a supplemental new drug application (sNDA) to include an indication for dasatinib (Sprycel) to treat children with Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia (CML), as well as a powder for oral...
FDA Grants 510(k) Clearance to Halcyon IMRT Treatment System
Varian Medical Systems has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Halcyon system, a new device for cancer treatment. Halcyon simplifies and enhances image-guided volumetric-intensity modulated radiotherapy (IMRT). “We are proud that Halcyon has now...
FDA Places Clinical Hold on Three Studies Evaluating Pembrolizumab in Multiple Myeloma
On July 5, Merck announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185, and KEYNOTE-023, three combination studies of pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, in multiple myeloma. This...
FDA Approves Aminolevulinic Acid Hydrochloride as an Optical Imaging Agent Indicated in Gliomas
ON JUNE 6, the U.S. Food and Drug Administration (FDA) approved aminolevulinic acid hydrochloride, known as ALA HCl (Gleolan), as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization [WHO] grades III or IV) for preoperative imaging, as an adjunct for the...
FDA Grants Marketing Approval to the Praxis Extended RAS Panel
On June 29, the U.S. Food and Drug Administration (FDA) granted marketing approval to the Praxis Extended RAS Panel, a next-generation sequencing test to detect certain genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer. The test is used to aid in 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...
FDA Approves Daratumumab in Combination With Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has approved the use of the monoclonal antibody daratumumab -(Darzalex) in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide ...
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...
Phase III CASCADE Trial of Vadastuximab Talirine in Front-Line AML Discontinued
On June 22, 2017, Seattle Genetics confirmed it discontinued the phase III CASCADE clinical trial of vadastuximab talirine (SGN-CD33A) in front-line older acute myeloid leukemia (AML) patients. Patient enrollment and treatment in all of its vadastuximab talirine clinical trials are suspended,...
Gideon M. Blumenthal, MD, Appointed OHOP Acting Deputy Office Director
Richard Pazdur, MD, Director of the Oncology Center of Excellence and Office of Hematology and Oncology Products (OHOP) Acting Director, has announced the appointment of Gideon M. Blumenthal, MD, as Acting Deputy Office Director of the OHOP at the U.S. Food and Drug Administration (FDA). Dr....
FDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During Chemotherapy
On July 3, the U.S. Food and Drug Administration (FDA) cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors. “We are pleased to expand the...
FDA Approves Panitumumab for Use in Wild-Type RAS Metastatic Colorectal Cancer
Today, 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 colorectal cancer...
FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas
On June 29, the U.S. Food and Drug Administration (FDA) allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency-authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin...
European Commission Expands Use of Ceritinib for First-Line Use in ALK-Positive Advanced NSCLC
On June 29, the European Commission approved expanding the use of ceritinib (Zykadia) to include the first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)–positive. Approval follows a positive opinion granted...
ESMO World GI 2017: Pegilodecakin Plus FOLFOX in Advanced Pancreatic Cancer
Clinical data on an investigational immuno-oncology drug pegilodecakin (PEGylated human interleukin-10, also known as AM0010) was presented by Hecht et al at the ESMO 19th World Congress on Gastrointestinal Cancer in Barcelona, Spain (Abstract O-004). Pegilodecakin is being evaluated in an ongoing...
FDA Unveils Plan to Eliminate Orphan Designation Backlog
Today, the U.S. Food and Drug Administration (FDA) unveiled a strategic plan to eliminate the agency’s existing Orphan Drug designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization...
FDA Takes Steps to Increase Drug Competition to Improve Patient Access
On June 27, the U.S. Food and Drug Administration (FDA) took two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and ...
FDA Approves Betrixaban for the Prophylaxis of Venous Thromboembolism
On June 23, 2017, the U.S. Food and Drug Administration (FDA) approved betrixaban (Bevyxxa) for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility...
ASCO Comments on Interchangeability of Biosimilars
ASCO submitted comments to the U.S. Food and Drug Administration (FDA) on the agency’s proposed guidance for industry on demonstrating the interchangeability of biosimilars with a reference product. The Society reiterated its strongly held position that physicians and patients should have the...
FDA Grants Regular Approval to Dabrafenib and Trametinib Combination for Metastatic NSCLC With BRAF V600E Mutation
On June 22, 2017, the U.S. Food and Drug Administration granted regular approvals to dabrafenib (Tafinlar) and trametinib (Mekinist) administered in combination for patients with metastatic non–small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. These ...
FDA Approves Daratumumab in Combination With Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has approved the use of the monoclonal antibody daratumumab (Darzalex) in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide...
FDA Approves Rituximab Plus Hyaluronidase Combination for Treatment of Certain Hematologic Malignancies
On June 22, 2017, the U.S. Food and Drug Administration granted regular approval to the combination of rituximab and hyaluronidase human (Rituxan Hycela) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. The approval provides a...
Strides Being Made in Advanced Urothelial Cancer
According to Srikala S. Sridhar, MD, MSc, FRCPC, of the Princess Margaret Cancer Centre, Toronto, Canada, “It’s an exciting time in the field of urothelial cancer,” thanks to the emergence of new therapies such as the immune checkpoint inhibitors and other approaches that aim to improve both...
