Tag Archives: FDA
FDA Streamlines Approval for Combination Drug Therapies
The Food and Drug Administration (FDA) recently released revised draft guidelines that could bring combination drug therapies to market sooner. These guidelines apply exclusively to drug cocktails that are used to treat serious illnesses such as cancer and heart disease. A streamlined review process of combination drug therapies may reduce development time by up to [...]
New Maintenance Therapy Methods for Lung Cancer
Several clinical experiments have attempted to improve the survival rates of patients dealing with non-small cell lung cancer (NSCLC) by stretching out the time span involved in the first stage of treatment. The idea behind this method, also known as maintenance therapy, is to attack the tumor after its initial regression stage instead of delaying [...]
News About Pharmaceuticals in Mesothelioma Treatment
1. New Biomarkers May Speed Diagnosis of Mesothelioma 2. Lowered Cost of DNA Sequencing Improving Specificity of Cancer Treatment 3. Scientists Find Cell Process That Causes Mesothelioma 4. Immune Response Inhibitor Identified in Cancer Retroviruses 5. MRIs Effective in Identifying Malignant Testicular Cancer Growths 6. National Comprehensive Cancer Network Announces New Mesothelioma Guidelines 7. New [...]
FDA Approves Alimta – Cisplatin Combination for Treatment of Asbestos-Related Cancer Mesothelioma
SOURCE: Eli Lilly and Company The first and only drug regimen proven to help patients with an asbestos-related cancer live longer was approved today by the U.S. Food and Drug Administration (FDA). Alimta® , to be introduced shortly by Eli Lilly and Company (NYSE: LLY), was approved for use with cisplatin, a standard chemotherapy agent, [...]
Predicting the Effectiveness of Avastin
A couple months ago, the FDA approved Avastin for use in treating brain cancer. The new approval is just the latest in a growing number of applications for the drug. First approved in 2004 to fight colorectal cancer, Avastin is now considered an avenue of treatment for lung, breast and other forms of cancer. However, [...]
FDA Recommends Additional Clinical Trial for Onconase
Members of the FDA met with Alfacell Corp. to discuss the final components of the Onconase New Drug Application (NDA). The company plans to submit an application for the treatment of unresectable malignant mesothelioma and was advised to conduct an additional clinical trial before submission. The FDA recommended the company conduct a trial on patients [...]
Onconase Phase IIIb Trial Posts Mixed Results
Alfacell announced that a Phase IIIb clinical trial involving Onconase failed to show a statistically significant improvement in median survival time for patients diagnosed with unresectable malignant mesothelioma. The study compared patients receiving Onconase (ranpirnase) and doxorubicin to those who only received doxorubicin. Out of 320 patients, the median survivial time for those receiving Onconase [...]
Alfacell Updates Status Of ONCONASE(R) Phase III Clinical Program
Source: MedicalNewsToday.com Alfacell Corporation announced it has confirmed that 290 evaluable events (patient deaths) have occurred in the Phase IIIb clinical trial of its lead compound, ONCONASE, for the treatment of patients with unresectable malignant mesothelioma. The number of evaluable events was confirmed after the company learned that total events in the study had reached [...]
Alfacell's Awkward Wait
Source: Fool.com By Brian Orelli It’s a sad fact in oncology clinical trials that use overall survival as an endpoint — people have to die for the trials to progress. For developmental-stage drug companies, the wait can be excruciating. Alfacell is in that position now with its lead drug candidate, Onconase, which is in its [...]
Alimta(®)-based Regimens Continue to Support Patients with Devastating Disease
Sept 5, 2007 Eli Lilly and Company Data Affirm Benefit of ALIMTA(®) (pemetrexed for injection) for Patients With Malignant Pleural Mesothelioma SEOUL, Sept. 4 /PRNewswire-AsiaNet/ — Data from two large, open-label studies show patients experienced one-year survival rates above 50 percent when treated with ALIMTA(R) (pemetrexed for injection) or ALIMTA-based regimens for malignant pleural mesothelioma [...]
