Search Results
Your search for ,Fda matches 3728 pages
Showing 2701 - 2750FDA Approves First Drug to Treat Myelofibrosis
The FDA has approved ruxolitinib (Jakafi), the first drug approved to specifically treat patients with the bone marrow disease myelofibrosis. Myelofibrosis is a disease in which the bone marrow is replaced by scar tissue resulting in blood cells being made in organs such as the liver and the...
Gathering Data Point to Potential Advantages of Vismodegib in Basal Cell Carcinoma and Other Advanced Cancers
Vismodegib is a small-molecule, orally active hedgehog pathway inhibitor that has shown considerable promise in treating basal cell carcinoma and is currently being evaluated alone and in combination in early-phase trials in medulloblastoma and a long list of other cancers.1 Owing to its...
New Drug Approved to Treat Acute Lymphoblastic Leukemia
The FDA has approved asparaginase Erwinia chrysanthemi (Erwinaze) to treat patients with acute lymphoblastic leukemia who have developed hypersensitivity to Escherichia coli–derived asparaginase (Elspar) and pegaspargase (Oncaspar). Acute lymphoblastic leukemia is the most commonly diagnosed...
2011 in Review: Oncology Drugs/Indications Newly Approved by FDA
At press time, the FDA had granted approval for the following new agents and indications for cancer treatment in 2011. Asparaginase Erwinia chrysanthemi (Erwinaze) as a component of a multiagent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in patients who have...
Optimizing HER2-directed Therapy in the Clinic
Seminal research in the treatment of HER2-positive breast cancer has been led by Edith A. Perez, MD, the Serene M. and Frances C. Durling Professor of Medicine at the Mayo Clinic, Jacksonville, Florida. The ASCO Post asked Dr. Perez to share her approach to HER2-directed therapy. Testing...
Breast Cancer Experts Voice Opinion and Express ‘Disappointment’ over FDA Decision
Gabriel N. Hortobagyi, MD, Chair of Medical Breast Oncology at The University of Texas MD Anderson Cancer Center, Houston, said he was “disappointed but not surprised” at the FDA decision to withdraw the bevacizumab (Avastin) indication in breast cancer. “Once the FDA put this in the hands of ODAC, ...
FDA Announces Bevacizumab Decision: Agency Will Revoke Breast Cancer Indication
On November 18, FDA Commissioner Margaret A. Hamburg, MD, said she is revoking the agency’s approval of the breast cancer indication for bevacizumab (Avastin) after concluding that the drug has not been shown to be safe and effective for that use. Bevacizumab will remain on the market as an...
New Indication for Cetuximab in Squamous Cell Carcinoma of the Head and Neck
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. Cetuximab (Erbitux) was recently approved by the FDA for use in...
Update on Novel Treatments for Peripheral T-cell Lymphoma
At the recent Pan-Pacific Lymphoma Conference in Kauai, Hawaii, Julie M. Vose, MD, from the University of Nebraska Medical Center, Omaha, discussed novel treatments for peripheral T-cell lymphoma (PTCL). PTCL is a heterogeneous group of aggressive T-cell/natural killer (NK) cell non-Hodgkin...
Advances in Lung Cancer Treatment Show Incremental Benefits, but Room for Improvement Remains
Newer therapies for the treatment of non–small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) were discussed at the Chemotherapy Foundation Symposium. More inroads have been made in improving outcomes for patients with NSCLC than for those with SCLC, but there is still room for...
Highlights of Bladder Cancer Research Include Novel Agents and New Approach to Identifying Biomarkers
It is an exciting time for researchers involved in developing new therapies for bladder cancer. More agents are in clinical development, drugs with novel mechanisms and novel trial designs are being implemented, and functional collaboration is occurring in the field, according to Noah Hahn, MD,...
Ruxolitinib for Myelofibrosis Therapy: A Good Start but a Long Road Ahead
Following a priority review process for orphan diseases, ruxolitinb (Jakafi) recently became the first drug to receive FDA approval for the treatment of intermediate- and high-risk myelofibrosis. Discovery in 2004 of the JAK2V617F mutation in a significant proportion of patients with...
First Genomic-based Pediatric Trials Launched in Neuroblastoma
Last November, Dell announced it was donating an initial $4 million including cloud-computing technology to speed up development of personalized medicine trials for children with neuroblastoma and other pediatric cancers. According to the American Cancer Society, about 650 children under the age of ...
Conquer Cancer Foundation Grantees Advance Cancer Care
Each year, the Conquer Cancer Foundation of ASCO funds Young Investigator Awards (YIAs) and Career Development Awards (CDAs). These research grants provide start-up funding for young physician-scientists as they embark on cancer research careers. Clearly, the programs are working: Six of the top...
NIH Director Calls for Rigorous Evaluation of Integrative Medicine to Provide Evidence of Efficacy
“Many new frontiers exist in integrative medicine,” NIH Director Francis Collins, MD, PhD, stated in his keynote address at the Eighth International Conference of the Society for Integrative Oncology (SIO) in Cleveland. “The evidence is overwhelming that these approaches are being used by many...
Estrogen for Vulvovaginal Atrophy in Breast Cancer: Debate Continues
Vulvovaginal atrophy is a concern for the majority of patients with breast cancer, not only because of its physical and psychosexual consequences, but because the optimal treatment—estrogen replacement—is controversial. Patients and physicians alike remain concerned that external estradiol may...
Sipuleucel-T Should Be Used Early in Metastatic Castrate-resistant Prostate Cancer, before Chemotherapy
When sipuleucel-T (Provenge) was approved by FDA in April 2010, it was the first vaccine to be approved as a treatment for prostate cancer and was hailed as a major advance. Although sipuleucel-T is now reimbursable by Medicare, some physicians are not clear about when to use it, and patients who...
Package Inserts Revised for IV Methotrexate Products
The FDA has approved changes to the package inserts for methotrexate products for intravenous administration. Additional information regarding concomitant proton pump inhibitor (PPI) therapy has been added to the Warning section of the label. Specifically, the new text includes the following...
Investigational New Drug Application Filed for ONT-10
Oncothyreon Inc announced the filing of an Investigational New Drug (IND) application with the FDA for ONT-10, a therapeutic vaccine directed at cancers expressing MUC1. Upon completion of the FDA’s review of the IND, Oncothyreon expects to initiate a phase I trial. ONT-10 is a therapeutic vaccine...
New System for Cervical Cancer Screening Approved
Hologic announced that the FDA has approved its Cervista HTA (high throughput automation) system for use with its previously approved Cervista human papillomavirus (HPV) HR test. The Company’s Cervista HTA system automates the DNA extraction and detection steps of the Hologic Cervista HPV HR test,...
ODAC Backs Axitinib for Kidney Cancer
The FDA’s Oncologic Drugs Advisory Committee voted 13-0 that Pfizer’s drug axitinib (Inlyta) had a favorable benefit-risk profile for patients with advanced renal cell carcinoma after initial treatment has failed. The FDA is due to make a final decision in the first half of 2012. Panelists said the ...
Bevacizumab Breast Cancer Indication Rescinded: What Are the Downstream Implications?
Leading up to FDA’s resolution to revoke the breast cancer indication for bevacizumab (Avastin), the debate over the drug’s clinical value was imbued with contentious ideologic overtones, which culminated in a 2-day public hearing that exposed deep divisions not only in the scientific community,...
FDA Approves Imatinib for Expanded Use in GIST
The FDA has granted imatinib mesylate (Gleevec) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). The new approval also highlights an increase in overall patient survival when the drug is taken for 36 months rather than...
Integration of QOPI® Helps Michigan Insurer Earn ‘Best of Blue’ Award
By working to improve oncology care in practices in Michigan through integration of ASCO’s Quality Oncology Practice Initiative (QOPI) into its Physician Group Incentive Program, Blue Cross Blue Shield of Michigan (BCBSM) has been selected as a 2011 “Best of Blue Clinical Distinction Award” winner...
Is Gemtuzumab a Therapeutic Option in Older Patients with Acute Myeloid Leukemia?
Previous studies of gemtuzumab ozogamicin (Mylotarg) had variable results in acute myeloid leukemia (AML). Before trials reported at the 2011 ASH Annual Meeting, two major studies had compared chemotherapy with or without gemtuzumab in patients with AML, said Martin Tallman, MD, Chief of the...
AVEREL 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...
