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Showing 2301 - 2350Metastatic Urothelial Carcinoma: A Model Malignancy for Immune Checkpoint Blockade
Platinum-based combination chemotherapy became a mainstay of first-line treatment for metastatic urothelial cancer in the 1980s. With combination platinum-based regimens, 40% to 50% of patients achieve an objective response to treatment. However, aside from approximately 5% to 10% of patients who...
CheckMate 275 Supports FDA Approval of Nivolumab in Metastatic Urothelial Carcinoma After Platinum Therapy
As reported in The Lancet Oncology by Padmanee Sharma, MD, PhD, of MD Anderson Cancer Center, and colleagues, the phase II CheckMate 275 trial has shown that nivolumab (Opdivo) produced durable responses in patients with metastatic urothelial cancer who had received at least one prior...
FDA Grants Accelerated Approval to Pembrolizumab for First Tissue/Site-Agnostic Indication
On May 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with unresectable or metastatic, microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed ...
Abemaciclib Active in Metastatic Breast Cancer
In the single-arm phase II MONARCH 1 trial, the investigational cyclin-dependent kinase 4/6 (CDK4/6) inhibitor abemaciclib achieved an objective response in about 20% of heavily pretreated patients with metastatic hormone receptor–positive, HER2-negative breast cancer and a disease control rate of...
FDA OCE Launches Drug Information Soundcast in Clinical Oncology (DISCO)
The FDA Drug Information Soundcast in Clinical Oncology (DISCO) is a new podcast series from the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE), covering new product approvals, emerging safety information for cancer treatments, and other current topics in cancer ...
FDA Approves Pembrolizumab for Advanced or Metastatic Urothelial Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted regular approval to pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or...
FDA Approves Ribociclib/Letrozole Co‑Pack for Postmenopausal Patients With Advanced or Metastatic Breast Cancer
On May 8, the U.S. Food and Drug Administration (FDA) approved the copackaging of ribociclib (Kisqali) and letrozole (Femara) tablets for the treatment of hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in postmenopausal ...
FDA Approves Pembrolizumab as First-Line Combination Therapy With Pemetrexed and Carboplatin for Metastatic Nonsquamous NSCLC
On May 10, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, in combination with pemetrexed (Alimta) and carboplatin for the first-line treatment of metastatic nonsquamous non–small cell lung cancer...
FDA Grants Accelerated Approval to Avelumab for Urothelial Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (Bavencio) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant...
Blinatumomab ‘Takes a BiTE’ Out of Acute Lymphoblastic Leukemia
An investigational immunotherapy is improving outcomes in difficult-to-treat acute lymphoblastic leukemia (ALL) and showing promise in other cancers, as well. Blinatumomab (Blincyto), the first U.S. Food and Drug Administration (FDA)-approved bispecific T-cell engager (BiTE), has demonstrated...
Nivolumab/Ipilimumab Combination Improves Survival Over Ipilimumab Alone in Patients With Melanoma
The race is on to identify combinations of immune checkpoint inhibitors that can improve outcomes over the use of immune checkpoint inhibitor monotherapy. Updated results of the phase III CheckMate 067 trial found the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) improved survival in...
Introduction: CDK4/6 Inhibitors: Moving Beyond the Breast Cancer Setting
The novel mechanism of action of drugs that inhibit the cyclin D–dependent kinases CDK4 and CDK6 has prompted effective new treatment strategies. Although the bulk of the data supporting the use of selective CDK4/6 inhibitors is currently in breast cancer, patients with other tumor types are...
FDA Approves Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to durvalumab (Imfinzi) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease...
FDA Approves Brigatinib for Metastatic ALK-Positive Non–Small Cell Lung Cancer
On April 28, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to brigatinib (Alunbrig) for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who have had disease progression on or are...
FDA Approves Midostaurin in Combination With Chemotherapy for Newly Diagnosed FLT3-Positive Acute Myeloid Leukemia
On April 28, 2017, the U.S. Food and Drug Administration (FDA) approved midostaurin (Rydapt) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation–positive, as detected by an FDA-approved test, in combination with standard cytarabine and...
FDA Grants Lorlatinib Breakthrough Therapy Designation for ALK-Positive Metastatic Non–Small Cell Lung Cancer
On April 27, the investigational next-generation ALK/ROS1 tyrosine kinase inhibitor lorlatinib was granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell...
FDA Expands Approved Use of Regorafenib for Hepatocellular Carcinoma
The U.S. Food and Drug Administration (FDA) has expanded the approved use of regorafinib (Stivarga) to include treatment of patients with hepatocellular carcinoma who have been previously treated with the drug sorafenib (Nexavar). This is the first new FDA-approved treatment for liver cancer in...
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 on ...
Trastuzumab Biosimilar Could Lead to Lower Health-Care Costs and Greater Drug Access for Patients With Metastatic Breast Cancer
The human epidermal growth factor receptor (HER) family consists of four members—epidermal growth factor receptor (EGFR), HER2, HER3, and HER4—all transmembrane receptor tyrosine kinases, which regulate cell growth and survival, differentiation, and migration, as well as other cellular responses.1 ...
Accelerating Pediatric Drug Development: Master Protocols May Be a Way to Go
Development of pediatric cancer drugs has long lagged behind adult drug development for two major reasons: The process is more difficult, and childhood cancer is rarer by far than adult cancer. These and other phenomena in pediatric oncology were the subject of a workshop held by the Friends of...
Monoclonal Antibody Therapy With Daratumumab in Multiple Myeloma: Expanding Therapeutic Horizons
The advent of successful monoclonal antibody therapy in the treatment of relapsed/refractory myeloma has dramatically improved the prognosis of patients for whom currently approved novel therapies have failed. In 2015, the approval of the combination of elotuzumab (Empliciti) with lenalidomide...
Updated Data on Treatment With Ibrutinib and Venetoclax in Patients With CLL/SLL
Long-term follow-up of treatment with ibrutinib (Imbruvica) in patients with previously untreated and treated chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) has shown high response rates that are durable. At 5 years, 89% of patients with treatment-naive and relapsed or...
Institute for Clinical Immuno-Oncology White Paper Highlights Challenges, Progress, and Priorities in Immunotherapy
Momentum around immunotherapies for cancer continues to build, but the high cost of these therapies places them at the center of debate about how best to define and measure value in cancer care. As these therapies are increasingly integrated into practice, all stakeholders—providers, patients,...
FDA Permits Marketing for Digital Pathology Solution for Primary Diagnostic Use
The U.S. Food and Drug Administration (FDA) has permitted marketing of the Philips IntelliSite Pathology Solution (PIPS, Philips Medical Systems Nederland B.V.), as an aid to pathologists to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin...
FDA Grants Atezolizumab Accelerated Approval as Initial Treatment for Some Advanced Bladder Cancers
On April 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy. Atezolizumab was previously approved for people...
ASCO Releases Position Statement on Access to Investigational Drugs
ASCO strongly supports increasing access to investigational new treatment options for patients with cancer, while raising serious concerns about recently proposed federal “right-to-try” legislation as well as state-enacted right-to-try laws. In a position statement released April 4, 2017, ASCO said ...
Next-Generation Genitourinary Oncology: Keeping One’s Powder Dry
There is a new yin-yang of management in genitourinary oncology, with the balance of opposing power focused among cancer cells, kinase inhibition, and lymphocyte function, representing a shift in the fashions of treatment somewhat away from chemotherapy. This linear progress has been complicated...
FDA Removes Risk Evaluation and Mitigation Strategy Requirements for Erythropoiesis-Stimulating Agents
On April 13, the U.S. Food and Drug Administration (FDA) removed the risk evaluation and mitigation strategy (REMS) requirements for the use of epoetin alfa and darbepoetin alfa to treat patients with anemia due to associated myelosuppressive chemotherapy. The Agency's announcement regarding...
FDA Grants Marketing Authorization for Ipsogen JAK2 RGQ PCR Kit to Detect JAK2 Genetic Mutations
The U.S. Food and Drug Administration (FDA) has granted marketing authorization to the ipsogen JAK2 RGQ PCR Kit, manufactured by QIAGEN GmbH, to detect mutations affecting the Janus tyrosine kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating...
Thomas E. Starzl, MD, PhD, ‘Father of Modern Transplantation,’ Dies at Age 90
Scientific and clinical pioneers have one thing in common: they move beyond their comfort zone and take calculated risks. One such pioneer, whose calculated risks gave hope to otherwise hopelessly ill people, was Thomas E. Starzl, MD, PhD, who performed the world’s first successful liver...
FDA Approves Maintenance Niraparib for Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
The U.S. Food and Drug Administration (FDA) has approved niraparib (Zejula) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, whose tumors have achieved complete or partial response to platinum-based chemotherapy....
FDA Approves Avelumab for Metastatic Merkel Cell Carcinoma
The U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (Bavencio) on March 23, 2017, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy. Avelumab is a...
AACR 2017: Adding the IDO-Pathway Inhibitor Indoximod to Pembrolizumab Improved Response Rate in Melanoma
Adding the investigational immunotherapy indoximod to the immunotherapy pembrolizumab (Keytruda) increased the proportion of patients with advanced melanoma who responded to treatment compared with previously reported response rates for pembrolizumab monotherapy, according to interim results from a ...
ASCO’s State of Cancer Care in America: 2017 Report Acknowledges Both the Progress Made in Oncology Care and the Challenges Ahead
Despite advances in cancer risk assessment, prevention, disease detection, drug development, and health-care delivery, which have led to unparalleled reductions in cancer incidence and mortality, access to affordable health care and increased administrative burdens placed on oncology practices...
AACR 2017: Combination of Nivolumab and Ipilimumab Improved Overall Survival in Advanced Melanoma
Among patients with advanced melanoma, those who received both nivolumab (Opdivo) and ipilimumab (Yervoy) had improved overall survival compared with those who received only ipilimumab, and appeared to have more favorable survival outcomes compared with those who received nivolumab, according to...
Palbociclib Receives FDA Approval and Expanded Indication for First-Line Metastatic Breast Cancer
On March 31, the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for a first-in-class cyclin-dependent kinase (CDK) 4/6 inhibitor, palbociclib (Ibrance), based on the results from the confirmatory phase III trial PALOMA-2. The FDA action converts the...
AACR 2017: Cancer Type and Mutation Identity Influenced Response to Neratinib in a Basket Clinical Trial
In the phase II SUMMIT clinical trial, the likelihood that a patient’s cancer responded to the investigational pan-HER–targeted therapeutic neratinib was influenced by both the cancer type and the identity of the gene mutation present in the cancer, according to results presented by...
FDA Grants Osimertinib Full Approval in Metastatic EGFR T790M Mutation–Positive NSCLC
On March 30, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to osimertinib (Tagrisso) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation–positive non–small cell lung cancer (NSCLC), as detected by an...
Assessment of Immunohistochemistry Assays for PD-L1 Expression in NSCLC
In a study of four immunohistochemistry programmed cell death ligand 1 (PD-L1) expression assays registered with the U.S. Food and Drug Administration (FDA), scoring was highly concordant for expression in tumor cells but poorly concordant for scoring in immune cells in non–small cell lung...
FDA Approves Maintenance Niraparib for Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
The U.S. Food and Drug Administration (FDA) has approved niraparib (Zejula) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, whose tumors have achieved complete or partial response to platinum-based chemotherapy....
Guidelines Planned on Management of Immunotherapy Side Effects: ASCO and NCCN to Collaborate on Development
Given the pace of advances in immunotherapy in recent years and physicians’ need to keep up with these developments, ASCO and the National Comprehensive Cancer Network® (NCCN®) have announced a joint collaboration to publish practical clinical guidance on the management of side effects caused by...
FDA Approves Avelumab for Metastatic Merkel Cell Carcinoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to avelumab (Bavencio) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy. Avelumab is a programmed cell...
Pacritinib Update
An article in the March 10, 2017, issue of The ASCO Post reported on a presentation from the 2016 American Society of Hematology (ASH) Annual Meeting & Exposition, noting that the investigational drug pacritinib has been shown to reduce spleen volume in myelofibrosis. The article erroneously...
ASCO Addresses New Policies That Threaten Access to Opioids
Since the mid-2000s, medication and illicit drug abuse in the United Sates has steadily increased, creating what has now been termed an “opioid epidemic.” In response, Congress and the Bush and Obama Administrations have launched intervention and regulatory proposals to help turn the troubling...
ASCO Releases Its State of Cancer Care in America: 2017 Report
In a press briefing today on Capitol Hill, ASCO presented its fourth annual State of Cancer Care in America: 2017 report, which found that although the cancer care delivery system in the United States is undergoing profound changes to better meet the needs of cancer survivors, persistent hurdles...
FDA Approves Pembrolizumab for Relapsed or Refractory Classical Hodgkin Lymphoma in Adult and Pediatric Patients
The U.S. Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda), an anti–PD-1 (programmed cell death protein 1) therapy, for the treatment of adult and pediatric patients who have refractory classical Hodgkin lymphoma or have relapsed after three or more prior lines of...
ASCO Honors Researchers and Scientists for Significant Advancements in Cancer Treatment and Care
ASCO and the Conquer Cancer Foundation of ASCO (CCF) have proudly announced the winners of ASCO's Special Awards, the Society's highest honors, and the CCF Women Who Conquer Cancer Mentorship Award. The recipients of these awards include researchers, patient advocates, and global oncology leaders...
FDA Approves Ribociclib as Initial Therapy for Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
On March 13, 2017, the U.S. Food and Drug Administration (FDA) approved ribociclib (Kisqali), a cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor–positive,...
Spotlight: ASCO Clinical Affairs
ASCO is working—through research, education, and promotion of the highest quality patient care—toward a world where cancer is prevented or cured, and every survivor is healthy. With the goal of ensuring that all patients receive the high-quality care they expect and deserve, ASCO is committed to...
Scripps Florida Collaboration Awarded $3.3 Million to Develop Next-Generation Breast Cancer Therapies
A pair of scientists from the Florida campus of The Scripps Research Institute (TSRI) have been awarded up to $3.3 million from the National Cancer Institute of the National Institutes of Health (NIH) to create the next generation of breast cancer treatments for the thousands of patients whose...
