It’s been a rough few months for Ariad Pharmaceuticals, but the Cambridge, MA-based company finally got some good news today.
The FDA has given Ariad the green light to bring its cancer drug, ponatinib (Iclusig), back to the U.S. market in the middle of January.
While that’s big news for Ariad—ponatinib is its only drug—it comes with a catch. Once it returns, ponatinib can only be prescribed to a smaller patient group, and Ariad has to fulfill various post-marketing requirements, such as a mandatory trial to test other doses, and closer oversight for potential safety problems. Bloomberg had more in an interview today with Ariad CEO Harvey Berger.
Ariad shares soared more than 25 percent on the news.
The new label will have updated safety information, and dosing recommendations. Ponatinib will now essentially be a last-resort therapy for patients with chronic myeloid leukemia “for whom no other tyrosine-kinase inhibitor therapy” like Novartis’ imatinib (Gleevec) can be prescribed.
Just a few months ago, Ariad had been hoping to beat imatinib head-to-head in a trial and become a frontline treatment for CML patients. Ponatinib will still be available for patients with T315I-postive, Philadelphia-chromosome-positive acute lymphoblastic leukemia
The FDA added a warning to the label to alert patients and doctors to the risk of heart failure and blood clots. The recommended daily dose of 45 milligrams remains the same.
About 640 patients were on ponatinib in the U.S. in October before Ariad pulled it off the market due to FDA concerns. Since that time, patients have been getting access to the drug through single-patient investigational new drug applications to the FDA. About 350 of those have been approved so far, according to Ariad.
Ariad must also run a randomized, multi-arm study for a range of ponatinib doses for patients with CML.
“As we look ahead to re-launching Iclusig in the U.S. and fulfilling our post-marketing requirements, we will continue to focus on understanding the benefits and risks of Iclusig treatment in patients with resistant or intolerant Philadelphia-positive leukemias,” Berger said in a statement.
Ariad had lost more than 70 percent of its value earlier this year after it halted—and later scrapped altogether—a trial pitting ponatinib against imatinib, due to safety concerns. Namely, patients dosed with Ariad’s drug experienced serious blood clots and other toxicities at a higher-than-expected rate.
Ariad has since announced plans to slash 40 percent of its U.S. workforce.