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Showing 2751 - 2800AVEREL Trial Shows Benefit of Bevacizumab in HER2-positive Locally Recurrent or Metastatic Breast Cancer
In findings likely to intensify the debate about the role of bevacizumab (Avastin) in advanced breast cancer, the AVEREL trial concludes that adding this antiangiogenic antibody to standard therapy prolongs progression-free survival by about 3 months in women with HER2-positive locally recurrent...
Subcutaneous Bortezomib Approved
The FDA has approved a supplemental new drug application for bortezomib (Velcade), updating the label to include the subcutaneous administration in all indications approved for intravenous administration, ie, multiple myeloma and mantle cell lymphoma after at least one prior therapy. The approval...
FDA Completes Work on Three Drug User Fee Programs
The FDA recently completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biologic products to patients, according to FDA Commissioner Margaret A. Hamburg, MD. The programs include the fifth authorization of...
Shared REMS Approved for all Transmucosal Immediate-release Fentanyl Products
The FDA has approved a new transmucosal immediate-release fentanyl Risk Evaluation and Mitigation Strategy (REMS) access program. The REMS is a single shared system for all transmucosal immediate-release fentanyl products. Among the goals of the REMS access program are to mitigate the risk of...
Glucarpidase Approved to Treat Methotrexate Toxicity
The FDA has approved intravenous glucarpidase (Voraxaze) to treat patients with toxic levels of methotrexate in their blood due to kidney failure. Glucarpidase is an enzyme that rapidly reduces methotrexate levels by breaking down the chemotherapy drug to a form that can be eliminated from the...
Ingenol Mebutate Approved for Topical Actinic Keratosis Therapy
The FDA has approved ingenol mebutate (Picato) gel for the topical treatment of actinic keratosis. At a concentration of 0.015%, the gel is used once daily on the face and scalp for 3 consecutive days, whereas a 0.05% dosage form is used once daily on the trunk and extremities for 2 consecutive...
FDA Approves Vismodegib for Basal Cell Carcinoma
The FDA has approved vismodegib (Erivedge) to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients with metastatic...
Axitinib Receives FDA Approval in Advanced Renal Cell Carcinoma
The FDA has approved the kinase inhibitor axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. The approval is based on an international, randomized, open-label trial that enrolled 723 patients: 361 were assigned to receive axitinib at 5 ...
Drug Shortages Hit Oncology Hard: Experts Weigh in on Challenges and Solutions
Periodic drug shortages are an unavoidable reality in our complicated pharmaceutical supply chain; however, over the past several years, drug shortages have expanded to crisis levels, putting vulnerable patients at risk. In 2010, there were 178 drug shortages reported to the FDA, 132 of which were...
Expert Point of View: Next-generation Proteasome Inhibitors Will Improve Outcomes in Bortezomib-refractory Myeloma Patients
Myeloma experts agree that the new proteosome inhibitors are particularly welcome because they are at least as effective as bortezomib (Velcade) but produce much less neuropathy. Dramatic Results “The activity of MLN 9708 is very encouraging,” said Paul G. Richardson, MD, of Dana-Farber Cancer...
Next-generation Proteasome Inhibitors Will Improve Outcomes in Bortezomib-refractory Myeloma Patients
The next-generation proteasome inhibitor carfilzomib is expected to gain FDA approval in the near future, offering a treatment option that may be as effective as and less neurotoxic than bortezomib (Velcade). Studies presented at the ASH Annual Meeting upheld benefits of the drug observed in...
A Second Chance for Gemtuzumab in Acute Myeloid Leukemia
Gemtuzumab ozogamicin (Mylotarg) may have a second chance for regulatory acceptance, as studies presented at ASH 2011 demonstrated that gemtuzumab can be safely and effectively given by adjusting the dosing and treatment schedule. Gemtuzumab ozogamicin was approved for the treatment of acute...
Expert Point of View: Bevacizumab Progression-free Survival Benefit Upheld in AVEREL Trial
Modest benefit reported from AVEREL1 triggered comments among trialists about the future of bevacizumab (Avastin) in breast cancer. “Although there’s controversy about the recent revoking of FDA approval of bevacizumab for metastatic breast cancer, I think there is a consensus in our disappointment ...
Pertuzumab Gets Priority Review for Metastatic Breast Cancer
The FDA has accepted Roche’s Biologics License Application for pertuzumab (Omnitarg) and granted Priority Review. The proposed indication is pertuzumab in combination with trastuzumab (Herceptin) and docetaxel chemotherapy for people with HER2-positive metastatic or locally recurrent, unresectable ...
FDA Issues Draft Guidance on Biosimilar Product Development
The FDA recently issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. “When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at...
Carfilzomib May Offer Advantages in Patients with Relapsed/Refractory Multiple Myeloma
Carfilzomib is an oral second-generation proteasome inhibitor with a mechanism of action that may increase efficacy and reduce adverse effects currently associated with proteasome inhibitor therapy. It is being investigated for use in multiple myeloma and select solid tumors, and the FDA has...
Expert Point of View: Two Novel Agents Prolong Survival in Advanced Prostate Cancer
“My comment on the AFFIRM trial is ‘wow, very impressive.’ The median survival and the declines in PSA levels are impressive, and this is going to change the way we care for patients in our practices,” said Nicholas Vogelzang, MD, medical oncologist with Comprehensive Cancer Centers of Nevada and...
Two Novel Agents Prolong Survival in Advanced Prostate Cancer
Two novel agents with distinct mechanisms of action join ranks of treatments that extend survival for patients with castration-resistant prostate cancer: MDV3100 and radium-223. Both drugs achieved a survival advantage compared with placebo, with relatively benign side-effect profiles, according to ...
VEGFR Tyrosine Kinase Inhibitors Linked to Increased Risk of Fatal Adverse Events
A meta-analysis of 10 randomized controlled trials involving 4,679 patients showed that the use of vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors was associated with an increased risk of fatal adverse events. “The crude incidence of [fatal adverse events] in patients ...
AACR Urges Congress to Maintain, Preferably Increase, Cancer Research Funding
December 23, 2011, marked the 40th anniversary of the National Cancer Act. To mark that occasion, on February 2, the American Association for Cancer Research (AACR) held a Congressional briefing, attended by about 100 legislative aides, to remind Congress that the war on cancer is far from over....
FDA Drug Approvals, January–March 2012
Imatinib mesylate tablets (Gleevec) approved for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive gastrointestinal stromal tumors (GIST). Accelerated approval for this indication was granted in December 2008. Vismodegib (Erivedge) capsules...
First Urine-based Molecular Test to Gauge Need for Repeat Prostate Biopsies
Gen-Probe announced the FDA has approved its PROGENSA PCA3 (prostate cancer gene 3) assay, the first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy. “Overexpression of the PCA3 gene is highly specific to cancerous prostate...
Ki-67 Image Analysis and Digital Read Applications Cleared
Ventana Medical Systems, Inc, received 510(k) clearance from the FDA for the Ventana Companion Algorithm Ki-67 (30-9) image analysis application used with the Ventana iScan Coreo Au scanner running Virtuoso software. Ventana is currently the only company offering an FDA-cleared Ki-67 image...
ODAC Votes against Denosumab to Delay Bone Metastasis in Men with Castration-resistant Prostate Cancer
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 1 that the risk-benefit ratio was insufficient for an expanded use of denosumab (Xgeva) to delay the spread of prostate cancer to the bone in men with castration-resistant disease. The panel was not asked specifically whether it...
New Colonoscopy System Cleared by FDA
A developer of endoscopy products based in New York and Kissing, Germany, invendo medical, announced that the company received 510(k) clearance by the FDA of the company’s new C20 colonoscopy system, including the SC20 single-use colonoscope. The invendoscope SC20 has several features that are...
FDA Acts to Bolster Supply of Critically Needed Cancer Drugs
The FDA has announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages. The President’s order, issued last October 31, directed the FDA to take action to help further prevent and reduce...
Pre–Annual Meeting Seminar Series Kicks Off
This year, ASCO is cosponsoring a new series of intimate, discussion-based seminars to be held just before the start of the Annual Meeting in June. The three seminars, which start at 1:00 PM on Thursday, May 31, and continue through noon on Friday, June 1, the first day of the Annual Meeting, are: ...
ASCO Launches Community Research Forum to Tackle Top Research Conundrums
Just how many research-focused staff members is it optimal to have when conducting clinical trials in a community-practice setting? To properly gauge that, should the practice look closely at how many studies it’s working on? The complexity of those studies? The number of patients enrolled? Some...
Answer to Secondary Cancers with RAF Inhibitors May Be Concomitant MEK Inhibition
Keratoacanthomas and cutaneous squamous cell carcinomas are frequently observed in patients receiving the RAF inhibitor vemurafenib (Zelboraf) for treatment of BRAF-mutated melanoma. As discussed by Lacouture and colleagues in a recent Journal of Clinical Oncology article, these effects appear to...
Immune Changes Reported with Early Use of Sipuleucel-T in Neoadjuvant Setting for Prostate Cancer
Sipuleucel-T (Provenge) can generate a circulating immune response to treat men with metastatic castrate-resistant prostate cancer, as per its FDA-approved indication.1 A neoadjuvant trial was performed to investigate whether earlier use of sipuleucel-T can generate an immune response in the...
Searching for Quality in an Increasingly Complex Health-care Environment
With the Presidential election just around the corner, the health-care debate will undoubtedly heat up. The ASCO Post spoke with Sean R. Tunis, MD, MSc, Founder and Director, Center for Medical Technology Policy, and former Chief Medical Officer for the Centers for Medicare & Medicaid Services, ...
GU Symposium 2016: Cabozantinib Improves Upon the Standard of Care for Advanced Kidney Cancer
New analyses from a phase III clinical trial of patients with previously treated advanced kidney cancer demonstrated that patients of all risk levels experience more benefit from cabozantinib (Cometriq) than from the current standard of care, everolimus (Afinitor). The greater activity of...
ASCO’s Blueprint Sets Goals for Accelerating Cancer Progress
ASCO recently issued a report, Accelerating Progress Against Cancer: ASCO’s Blueprint for Transforming Clinical and Translational Cancer Research, which outlines the Society’s 10-year plan for improving cancer outcomes. Central to achieving that goal are three steps, including (1) therapy...
FDA Drug Approvals, January–April 2012
Imatinib mesylate tablets (Gleevec) approved for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive gastrointestinal stromal tumors (GIST). Vismodegib capsules (Erivedge) approved for the treatment of metastatic basal cell carcinoma or locally...
Liposomal Vincristine Receives Positive Vote from ODAC
Talon Therapeutics, Inc, announced the Oncologic Drugs Advisory Committee voted 7 yes, 4 no, and 2 abstain that evidence from clinical studies supports a favorable benefit-risk assessment for use of vincristine sulfate liposomes injection (Marqibo). The manufacturer is seeking an indication for the ...
FDA Approves New Silicone Gel–filled Breast Implant
The FDA recently approved a silicone gel-filled breast implant manufactured by Sientra Inc for breast augmentation in women at least 22 years old and breast reconstruction in women of any age. As a condition of approval, Sientra is required to conduct postapproval studies that will assess long-term ...
FDA Commissioner Statement: Surgeon General’s Report on Youth Smoking
The recent report on “Preventing Tobacco Use Among Youth and Young Adults” by the Surgeon General not only documents the devastating consequences of tobacco use for our nation’s youth, but also represents a clarion call for bold action at every level of government to implement proven strategies to...
ODAC Offers Recommendations on Two Sarcoma Drugs
The FDA’s Oncologic Drugs Advisory Committee (ODAC) recently recommended approval of one drug for sarcoma but rejected another. The panel voted 11 to 2 that clinical studies support a favorable benefit-risk assessment for use of pazopanib (Votrient) in treating patients with advanced soft-tissue...
Update on Novel Anticoagulants: Dabigatran Etexilate
Efficacy and safety of traditional anticoagulants (eg, vitamin K antagonists) are well recognized, given their long-standing use in clinical practice. However, the novel anticoagulants have several potential advantages over the vitamin K antagonists. Even so, in light of their recent introduction...
Treating Acute Promyelocytic Leukemia without Chemotherapy
Throughout the course of medical history, we have witnessed innovations that have initially been met with skepticism but have later revolutionized our management of patients with specific disorders. The recent history of oncology drug development is full of instances where a drug that was...
ASCO Advocates for Solutions to Oncology Drug Shortage Crisis
ASCO continues to call for three specific actions by Congress to help avert shortages of essential treatments for children and adults living with cancer. ASCO President Michael P. Link, MD, outlined the priorities in February at an FDA news briefing on the recent methotrexate and liposomal...
Cancer Informatics: A Future Necessity, but Challenges Abound
The National Cancer Policy Forum of the Institute of Medicine (IOM) recently convened a workshop on cancer informatics to examine and discuss needs and challenges facing biomedical researchers, which will in turn affect the way oncology is practiced in the future. “This is a time of huge scientific ...
An Expert Shares Insight into the Future of Lung Cancer Treatment
Despite growing national focus on early detection, prevention, and new molecular-based treatments, lung cancer persistently remains the number 1 cause of cancer death for men and women in the United States. The ASCO Post spoke to lung cancer specialist Paul A. Bunn, Jr, MD, Executive Director,...
Surgeon General Releases New Report on Youth Smoking
The fight against tobacco use among young people was accelerated recently by Surgeon General Regina M. Benjamin, MD, MBA, with the release of the Surgeon General’s Report, Preventing Tobacco Use Among Youth and Young Adults. This report details the scope, health consequences, and influences that...
Institute of Medicine Report on Omics-based Testing Bolsters ASCO’s Blueprint for Transforming Cancer Research
A recent report by the Institute of Medicine (IOM) addresses elements that ASCO has stated are necessary for transforming the therapeutic development and clinical trial processes. In March, the IOM released the report “Evolution of Translational Omics: Lessons Learned and the Path Forward,” which...
FDA Approves Investigational New Drug Application for Clinical Testing of Oncology Drug Candidate ME-344
Marshall Edwards, Inc, an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, announced that it has received approval from the FDA of its Investigational New Drug (IND) application for ME-344, the Company’s lead mitochondrial inhibitor. The...
Clinical Findings and Consequences of Distributing Counterfeit Drugs for Hematology and Oncology
As introduced in our report on page 1 of this issue, counterfeit pharmaceuticals are an increasingly important safety concern, and three of the most prominent drug-counterfeiting episodes in recent years have involved hematology/oncology products. Counterfeit Erythropoietin Helen B., a 61-year-old...
Defining Meaningful Benefit: The Debate Continues in Bevacizumab’s Wake
The events surrounding the labeling of bevacizumab (Avastin) have been well covered since last November when the FDA withdrew the drug’s accelerated approval as a treatment for metastatic breast cancer. However, the controversy initiated a debate over the value of endpoints in clinical trials in...
Caveat Oncologist: Counterfeit Pharmaceuticals
In 2002, Tim F., a 17-year-old liver transplant patient, received 40,000 units of erythropoietin weekly, beginning immediately after his transplantation procedure.1 His family had purchased the product from the local CVS Pharmacy, upon his discharge from a Manhattan hospital. After each injection,...
Expert Point of View: Novel Multikinase Inhibitor Improves Survival in Metastatic Colorectal Cancer
The results of the CORRECT trial created some degree of “buzz” at the 2012 Gastrointestinal Cancers Symposium, with experts predicting that regorafenib will become FDA-approved and have strong clinical utility. While numerically, the benefit appeared small, “There is a real difference with this...
