FDA grants APP fast track status for breast cancer drug

17 January 2003 16:48  [Source: ICIS news]

HOUSTON (CNI)--The U.S. Food and Drug Administration (FDA) has granted fast track designation to American Pharmaceutical Partners (APP) for ABI-007, a treatment for metastatic breast cancer, company officials said Friday.

The Los Angeles, California-based injectable drug specialist said it has worked closely with the FDA in a testing phase of the drug that began in 1996 and was granted the status because ABI-007, a cremophor-free nanoparticle paclitaxel, has the potential to address an unmet medical need.

Fast track designation means APP will continue to work closely with the FDA to submit a new drug application in sections rather than all components at once.

APP announced last month that testing showed ABI-007 was infused over 30 minutes without steroid pretreatment at a higher dose than Taxol, which requires steroid therapy and infusion over three hours. APP said that Taxol, manufactured by Bristol-Myers Squibb, contains cremophor and is responsible for many of the well-known side effects and administration problems that limit the dose of paclitaxel that can be delivered.

APP chairman Patrick Soon-Shiony said with fast track status the company "may be able to more quickly provide a new therapeutic approach to the treatment of metastatic breast cancer."

APP develops manufactures and markets injectable pharmaceutical products that specialize in the oncology, anti-infective and critical care markets.





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