Ariad Pharmaceuticals ($ARIA) has taken another big step toward its first big regulatory approval, shaving weeks off its schedule to file an application for ponatinib in the U.S. as it races to the market with a new leukemia treatment. Now it's looking for an accelerated review from the FDA as it readies a possible launch of the new drug for chronic myeloid leukemia in early 2013.
"We were able to put the pedal to the metal and get it done ahead of schedule," Ariad CEO Harvey Berger told The Boston Globe. A European application is expected soon and Ariad is already at work building up a new headquarters facility in Switzerland as it prepares to make the big leap from R&D to commercialization.
Under the fast track status granted by the FDA, Ariad has already submitted the bulk of its data in a rolling submission designed to speed regulatory decisions. It will now push ahead with the positive data that the biotech aired at ASCO. Ponatinib is a tyrosine kinase inhibitor, targeting the BCR-ABL fusion proteins.
In June Cambridge, MA-based Ariad reported that 54% of leukemia patients on the targeted drug had a major cytogenetic response, besting the figure released during the ASH meeting in December. The pivotal trial involved more than 400 patients with CML or Philadelphia-positive acute lymphoblastic leukemia who have built up resistance or have intolerance to the marketed kinase inhibitors dasatinib, sold as Sprycel by Bristol-Myers Squibb ($BMY), or Novartis' ($NVS) nilotinib (Tasigna) or who have the T315I mutation.
As with many such cancer drugs, Ariad is seeking an approval to use the treatment for patients who had failed the standard of care, in this case Gleevec, Sprycel and Tasigna. Later the biotech will seek approval for use as a frontline therapy. Just days ago investigators started a head-to-head study with Gleevec, which is widely viewed as the gold standard in CML.
All hands on Ariad's deck are devoted to ponatinib now, which Ariad intends to market in the U.S. as well as Europe. Back in June the FDA rejected an application for ridaforolimus, complaining that Merck ($MRK)--which licensed the drug from Ariad--only offered weak data demonstrating marginal success against sarcomas. Merck is following up with additional studies.
- read the press release
- here's the story from The Boston Globe
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