FDA CLEARS TREATMENT IND FOR COLON CANCER DRUG LEVAMISOLE
Executive Summary
FDA CLEARS TREATMENT IND FOR COLON CANCER DRUG LEVAMISOLE in combination with 5-fluorouracil, the agency announced in a May 8 "Talk Paper." Under the Treatment IND protocol, levamisole, an immunostimulant with known anti-tumor effects in animals, may be used in conjunction with the approved cancer drug 5-flurouracil as an adjuvant treatment beginning seven to 30 days after surgical removal of the cancer. In addition, the National Cancer Institute has designated levamisole a Group C cancer treatment, indicating that the drug has been shown potentially effective and can be administered by properly trained physicians. In February, NCI released the results of preliminary studies conducted at the Mayo Clinic, which demonstrated a 30% improvement in survival rates of patients treated with the levamisole/fluorouracil combination. FDA estimates that more than 25,000 patients would be eligible for treatment each year under the protocol. More than 110,000 new cases of colon cancer will be diagnosed in 1989, while the disease will result in 44,000 deaths during the year, the agency said.
You may also be interested in...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Shire Hopes To Sow Future Deals With $50M Venture Fund
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth