© 2001 by Oxford University Press
Journal of the National Cancer Institute, Vol. 93, No. 13, 972,
July 4, 2001
© 2001 Oxford University Press
NEWS |
After 30 Years of Laboratory Work, a Quick Approval for STI571
STI571 was first tested in humans in June 1998. Its approval as GleevecTM came just under 3 years later on May 10, 2001, after the U.S. Food and Drug Administration completed its review of the new drug application in a mere 2 1/2 months. How did a process that can take a decade or more happen so quickly?
It took 30 years of solid laboratory work to lay the scientific foundation, a cancer that has an easy molecular target, and the willingness of a company to take on a drug with a relatively small market to bring STI571 to the clinic.
"Speed was an absolute priority for Novartis in developing this drug," said Daniel Vasella, M.D., chairman and chief executive officer of Novartis Pharmaceuticals, East Hanover, N.J. "We chose to take a significant risk at an early stage, reallocating resources and prioritizing the development of this drug." Novartis estimates that it has spent between $350 million and $500 million to develop STI571 since 1985.
And the company would find that they had good reason for such a risk. With promising data from preliminary studies in hand, Novartis filed a new drug application on Feb. 27, 2001, a mere 32 months after they began testing the drug in humans.
From there, the FDA granted the drug a priority review. It was also reviewed under the agency’s accelerated approval regulations, a process under which drugs may be approved based on studies with surrogate end points—in this case, overall hematologic and cytogenetic response rates—rather than improvement in disease-related symptoms or increased survival.
Even still, the time to approval was remarkably quick compared with other drugs approved under the same process (see box).
|
"The review team really understood the medical importance of this drug," said Richard Pazdur, M.D., director of FDA’s Division of Oncologic Drug Products. "What it meant was people giving up vacations, coming to work on Saturday, coming to work on Sunday, working until midnight, and missing soccer games."
Novartis is still required to complete a handful of studies to maintain the drug’s status, including a phase III trial comparing STI571 to interferon combined with cytarabine in patients with previously untreated CML. The company also plans to assess the drug in children and to study potential drug interactions.
If the drug does not continue to demonstrate therapeutic benefit, then, according to FDA documents, the agency "can withdraw the product from the market more easily than usual."
Vasella noted that the company has simultaneously filed for approval around the world; however, the United States was the first to approve it. The company expects approval in Europe and Japan by the middle of next year.
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  M. Cataldi, A. Gaudino, V. Lariccia, M. Russo, S. Amoroso, G. di Renzo, and L. Annunziato Imatinib-Mesylate Blocks Recombinant T-Type Calcium Channels Expressed in Human Embryonic Kidney-293 Cells by a Protein Tyrosine Kinase-Independent Mechanism J. Pharmacol. Exp. Ther., April 1, 2004; 309(1): 208 - 215. [Abstract] [Full Text]
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||