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Showing 2651 - 2700Elotuzumab in Previously Treated Multiple Myeloma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 30, 2015, elotuzumab (Empliciti) was approved for...
Multiple Myeloma in 2015: A Year for the Record Books
Few malignancies have received as much attention, in the way of newly approved drugs, as multiple myeloma did in 2015. In November alone, 3 new agents were approved, bringing the total to 4 for the year as part of a record 7 approvals and to 16 regulatory approvals over the past 12 years. Speakers...
FDA Approves Eribulin Mesylate in Unresectable or Metastatic Liposarcoma
The U.S. Food and Drug Administration today approved eribulin mesylate (Halaven), an antimicrotubular antineoplastic agent, for the treatment of unresectable or metastatic liposarcoma. This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug....
100% of NCI-Designated Cancer Centers Endorse the Promotion of the HPV Vaccination for Cancer Prevention
All National Cancer Institute (NCI)-designated cancer centers have united to support human papillomavirus (HPV) vaccination. A team of HPV experts drafted a consensus statement that advises widespread use of HPV vaccines to prevent cancer. HPV causes cancer of the cervix, anus, and throat. The HPV ...
Nivolumab Plus Ipilimumab Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status
Bristol-Myers Squibb announced on January 23 that the U.S. Food and Drug Administration (FDA) has approved nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation–positive unresectable or metastatic...
FDA Approves Carfilzomib as Single Agent or in Combination in Relapsed/Refractory Multiple Myeloma
Amgen announced on January 21 that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application of carfilzomib (Kyprolis) for injection in combination with dexamethasone or with lenalidomide (Revlimid) plus dexamethasone for the treatment of patients with relapsed or...
FDA Approves Ofatumumab for Patients With Chronic Lymphocytic Leukemia in Complete or Partial Response
The U.S. Food and Drug Administration today approved ofatumumab (Arzerra) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was previously approved for the...
FDA Issues Revised Draft Guidance on Financial Disclosure by Clinical Investigators
The FDA recently issued a draft guidance on financial disclosure by clinical investigators, intended to assist researchers, industry, and FDA staff in interpreting and complying with regulations found in the Code of Federal Regulations Title 21, Part 54. The draft is being distributed for comment...
Trabectedin New Drug Application Withdrawn
Centocor Ortho Biotech Products, LP, announced that it has voluntarily withdrawn the New Drug Application (NDA) for trabectedin (Yondelis) for the treatment of women with recurrent ovarian cancer. The withdrawal is based on the FDA’s recommendation that an additional phase III study be conducted to ...
FDA Approves Sunitinib for Pancreatic Neuroendocrine Tumors
The FDA approved sunitinib (Sutent) to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have metastasized. This is the second new approval by the FDA to treat patients with this disease. On May 5, the agency approved...
New Drug Application Submitted for Vemurafenib in Melanoma
Daiichi Sankyo announced that applications have been submitted for market approval for vemurafenib (PLX4032/RG7204) for the treatment of metastatic melanoma to the FDA and the European Medicines Agency (EMA). Additionally, a premarketing application for approval for a companion diagnostic test has...
Opinion: The FDA–Pharmaceutical Industry Complex
On January 17, 1961, President Dwight D. Eisenhower, in his farewell address to the nation, coined the term “the military-industrial complex.” His purpose was to warn of the inefficiencies that could result from such a relationship, which would imperil the strength of our military and the safety of ...
Changes Introduced to Better Inform Consumers about Sunscreen
The FDA announced that sunscreen products meeting modern standards for effectiveness may be labeled with new information to help consumers find products that, when used with other sun protection measures, reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn. The...
Test Approved to Help Determine Candidacy for Trastuzumab
The FDA has approved a new genetic test that will help health-care professionals determine whether women with breast cancer are HER2-positive and, therefore, candidates for trastuzumab (Herceptin). The test, called Inform Dual ISH, allows for measurement of the number of copies of the HER2 gene in...
Understanding Crizotinib, 1 Year after High-profile Presentation
The findings from a phase I study of crizotinib in non–small cell lung cancer (NSCLC) were presented in a Plenary Session at the 2010 ASCO Annual Meeting—an unusual event, since such early-phase data are not generally the topic of plenary sessions. The study showed that a majority of mostly...
Novel Agents Improve Survival in Patients with Metastatic Melanoma
Novel treatments for metastatic melanoma dominated the buzz at the 2011 ASCO Annual Meeting and across the major news outlets, with reports that two agents with entirely different mechanisms of action could extend survival. The studies’ inclusion in the ASCO Plenary Session attested to the...
Cervical Cancer Screening Study Should Reassure Physicians and Patients that a 3-Year Screening Interval Is Safe and Effective
Results of a large-scale cervical cancer screening study using concurrent human papillomavirus (HPV) and Pap testing should “reassure” women over 30 who test negative for HPV and have normal Pap tests that “it is extremely safe to go 3 years” before being tested again, Barnett S. Kramer, MD, MPH,...
My First of Many ASCO Meetings
In June, I attended my first ASCO Annual Meeting. Although I have been practicing and teaching urology for 35 years with a specific interest in genitourinary oncology and I have attended dozens of national meetings, the ASCO Annual Meetings were not on my radar. Focus on the Patient The...
FDA Issues Updated Safety Data on Silicone Gel–filled Breast Implants
The FDA has released a report updating the clinical and scientific information for silicone gel–filled breast implants, including preliminary safety data from studies conducted by the manufacturers (Allergan and Mentor) as a condition of their November 2006 approval. While the report confirms...
First Fentanyl Nasal Spray Approved for Cancer Breakthrough Pain
The FDA has approved fentanyl nasal spray (Lazanda) for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. This marks the first FDA product approval for...
Novel JAK Inhibitor May Be an Option for Patients with Myelofibrosis
A new approach to treating myelofibrosis appears to be paying off, according to several studies presented at the 2011 ASCO Annual Meeting. Treatment with a novel JAK inhibitor called ruxolitinib demonstrated significant and sustained improvement in splenomegaly and overall quality of life,...
ODAC Again Recommends FDA Withdraw Its Approval of Bevacizumab for Metastatic Breast Cancer
In June 2011, a public hearing was convened to consider an appeal of the December 2010 recommendation by FDA to remove the breast cancer indication for bevacizumab (Avastin). FDA’s recommendation late last year was in accordance with a July 2010 recommendation by the Oncologic Drugs Advisory...
Final Decision on Sipuleucel-T
The Centers for Medicare & Mediaid Services (CMS) issued a final decision to cover FDA-approved indications of sipuleucel-T (Provenge) in prostate cancer, calling the treatment “reasonable and necessary.” The CMS final decision assures provider reimbursement of sipuleucel-T for Medicare...
Exemestane Prevents Invasive and Preinvasive Breast Cancers in MAP.3 Trial
The aromatase inhibitor exemestane, taken for 5 years, significantly reduced invasive and preinvasive breast cancers in postmenopausal women at increased risk for the disease, in the large Canadian NCIC CTG MAP.3 randomized trial. Results of the trial were presented at the recent ASCO Annual...
Despite Advances, Little Overall Improvement Seen in Treatment of Older Adults with AML
The outcome of treatment of older adults with acute myeloid leukemia (AML) remains unsatisfactory, although certainly not a totally futile exercise. Patients satisfying the entry criteria for cooperative group clinical trials can be expected to have complete remission rates of 50% to 55%, with...
SIDEBAR: Expect Questions from Your Patients
Drugs for the treatment of prostate cancer have been in the news because of recent approvals by the FDA, the costs connected with their use, and associated improvements in survival.1 More recently reported was the decision to allow Medicare coverage of sipuleucel-T treatment for men who met the FDA ...
Optimizing Treatment for Advanced Prostate Cancer Requires Shifting Focus from Individual Drugs to Integrated Therapies
Newer drugs, including sipuleucel-T (Provenge), cabazitaxel (Jevtana), and abiraterone (Zytiga), can extend survival modestly and ease symptoms for men with advanced prostate cancer. Maximizing the benefit to patients will require shifting the focus from developing individual drugs to developing...
FDA Outlines Oversight of Mobile Medical Applications
The FDA is seeking input on its proposed oversight approach for mobile medical applications (“apps”) designed for use on smartphones and other mobile computing devices. This approach encourages the development of new apps, focuses only on a select group of applications, and will not regulate the...
New Safety Information Reported for 5-alpha Reductase Inhibitors
The FDA announced that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor class of drugs has been revised to include new safety information about the increased risk of being diagnosed with high-grade prostate cancer. This risk appears to be low, but health-care...
Oncology Community Briefs Members of Congress and Calls for Action
ASCO and seven other oncology organizations held a Capitol Hill briefing in July and explained to nearly 200 members of Congress and their staffs how widespread cancer drug shortages are creating “a crisis in care.” According to the University of Utah Drug Information Service, the number of drug...
ODAC Recommends Accelerated Approval for Brentuximab
Seattle Genetics, Inc, announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 10-0 to recommend that the agency grant accelerated approval of brentuximab vedotin (ADCETRIS) for the treatment of patients with Hodgkin lymphoma who relapse after autologous stem cell transplant...
FDA Issues Guidance for Diagnostic Tests Used with Targeted Therapies
The FDA issued a new draft guidance to facilitate the development and review of “companion diagnostics”—tests used to help health-care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft ...
Updated Drug Label Approved for Pioglitazone after Safety Review
The FDA recently approved updated drug labels for pioglitazone (Actos) and other pioglitazone-containing medicines (in combination with metformin, Actoplus Met and Actoplus Met XR; and with glimepiride, Duetact) to include safety information that the use of pioglitazone for more than 1 year may be...
Circulating Tumor Cell Assay Shows Potential for Predicting Prognosis in Head and Neck Carcinoma
According to the NCI, an estimated 49,260 new cases of oral cavity, pharyngeal, and laryngeal cancers occurred in the United States in 2010, and approximately 11,480 deaths were attributed to these cases. It is estimated that 95% or more of these cases are squamous cell carcinomas. Currently, the...
Congressional Hearing Highlights Oncology Drug Shortages
Some oncology drugs are in such short supply that the situation is now critical, with almost 200 drugs affected—triple that of 2003. This was the background described by speakers at a July 2011 congressional briefing sponsored by the Association of Community Cancer Centers (ACCC), ASCO, and other...
Fixing the Drug Shortage: It’s About Time
I have spent the past 30 years trying to improve the results of treatment for advanced cancer. I had the privilege of working with Sir Michael Peckham when the late Professor Tim McElwain and he were evolving variants of the PVB (cisplatin, vinblastine, bleomycin) and PEB (cisplatin, etoposide,...
Crizotinib plus Companion Diagnostic Test Approved in NSCLC
On August 26, 2011, the FDA granted accelerated approval to Pfizer’s crizotinib (Xalkori) for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The FDA approved the...
Integrative Oncology Modalities Supported by Varying Levels of Evidence, but More Research Needed Overall
Over the past couple of decades, unregulated nonstandard oncology approaches have gained growing popularity among cancer patients. The relatively new field of integrative oncology was established to promote a more holistic and multidisciplinary approach to cancer care and to encourage scientific...
Radium-223 Chloride Gets Fast Track Designation
Bayer HealthCare Pharmaceuticals, Inc, announced that its investigational compound radium-223 chloride, which is exclusively licensed from Algeta ASA, has been granted Fast Track designation by the FDA for the treatment of castration-resistant (hormone-refractory) prostate cancer in patients with...
FDA Clears Genetic FISH Panel for Leukemia Patient Prognosis
Abbott announced it has received 510k clearance from the FDA for a new in vitro diagnostic test to aid in determining the prognosis of patients with chronic lymphocytic leukemia (CLL). Abbott’s Vysis CLL FISH Probe Kit is the first FDA-cleared CLL test to aid in prognosis. The test detects genetic...
Action Date Set for Denosumab Supplemental Application
Amgen announced that the FDA will target a Prescription Drug User Fee Act (PDUFA) action date of April 26, 2012, for the supplemental Biologics License Application to expand the indication for denosumab (Xgeva) to treat men with castrate-resistant prostate cancer to reduce the risk of developing...
FDA Grants Orphan Drug Status to MM-398, a Nanotherapeutic Encapsulation of Irinotecan, to Treat Pancreatic Cancer
Merrimack Pharmaceuticals, Inc, announced that the FDA has granted MM-398 orphan drug status for the treatment of pancreatic cancer. MM-398 is a novel, stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan. MM-398 is partnered with PharmaEngine, Inc, for development and...
Developing Targeted-agent Combinations: Business and Regulatory Issues, and Legal Obstacles
The Institute of Medicine’s National Cancer Policy Forum recently convened a public workshop, “Facilitating Collaborations to Develop Combination Investigational Cancer Therapies,” to address the promises and challenges involved in the development of combination oncologic drug therapies. In the...
Oncology Drug Shortage: An Unintended Consequence of the Medicare Modernization Act and Free-market Forces?
Oncology has a drug shortage problem, and the FDA says that it is getting worse. Drug shortages are not a new phenomenon, but over the past few years we have seen a rapidly growing number of shortfalls that are limiting providers’ ability to care for their patients. In 2004, the FDA reported 58...
Novel BRAF Inhibitor Receives FDA Approval in Metastatic Melanoma
Vemurafenib (Zelboraf) received FDA approval on August 17, 2011, for treatment of metastatic or unresectable melanoma, based on the results of the phase III BRIM3 trial.1 BRIM3 compared vemurafenib to dacarbazine in 675 untreated patients with the BRAF V600E mutation. Vemurafenib targets the...
Important Benefit for Small Population Is a Major Milestone in Lymphoma
The approval of brentuximab vedotin (Adcetris) is a major milestone for the treatment of patients with relapsed Hodgkin lymphoma and anaplastic large cell lymphoma. It represents an excellent example of personalized cancer therapy. Patients are preselected based on a predictive biomarker that is...
FDA Approves Brentuximab Vedotin in Two Lymphoma Indications
The antibody-drug conjugate brentuximab vedotin (Adcetris) was granted accelerated approval on August 19 for the treatment of relapsed or refractory Hodgkin lymphoma and systemic anaplastic large cell lymphoma. Brentuximab vedotin is the first new drug to be approved in Hodgkin lymphoma in more...
Cancer Information on Wikipedia as Accurate as on PDQ but Harder to Understand
A comparison of cancer information on Wikipedia and the patient version of information on the NCI’s Physician Data Query (PDQ) “found that although Wikipedia had similar accuracy and depth to the PDQ, the written style was more complex and thus might be less understandable to patients.” According...
FDA Announces Changes in Drug Center’s Oncology Office
The FDA recently announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies. The Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products has been reorganized and renamed the Office of Hematology and...
Novel Drugs Ipilimumab and Vemurafenib for Advanced Melanoma
In this introductory installment of In the Clinic, The ASCO Post provides an overview of two new melanoma agents recently approved by FDA, with discussion on pivotal data leading to approval, dosage and administration, and managing drug-related toxicities. Watch for more on clinical use of novel...
