FDA grants speedy review to Ariad's blockbuster hopeful

Ariad Pharmaceuticals ($ARIA) notched another victory for its closely watched leukemia drug ponatinib today. The FDA has granted the company an accelerated review of the targeted cancer treatment for patients who have failed previous treatment for chronic myeloid leukemia or Philadelphia-chromosome positive acute lymphoblastic leukemia. The speedy review comes with action date of March 27.

Given the potential improvements for patients on the therapy, ponatinib has now won streamlined reviews from both European and U.S. regulators. These speedy reviews are often months shorter than standard evaluations of drug applications, potentially giving Cambridge, MA-based Ariad a leg up as it advances plans to launch the new therapy in the U.S. and Europe over the next year.

Ponatinib generated impressive results in a pivotal study, which showed that more than half of patients with chronic myeloid leukemia who failed prior treatment had a major cytogenetic response on the experimental BCR-ABL inhibitor. This is important because patients with the disease build resistance to current therapies such as Novartis' ($NVS) blockbuster Gleevec, and patients with resistant disease eventually run low on treatment options. 

Looking beyond resistant disease, the company is studying the drug in new cases of leukemia and potentially putting the therapy on a blockbuster path if the study succeeds. As Ariad CEO Harvey Berger has told Bloomberg, the treatment could bring annual sales of $800 million for patients who have failed previous treatments and hit $1.5 billion with the additional use against new cases.   

- here's Ariad's release
- check out Reuters' article

Special Report: Ponatinib – Top 10 Late-Stage Cancer Drugs – 2012

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.