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Major Clinical Trials for Iclusig Halted

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Jarod Cassidy4 years ago

Clinical trials for Ariad’s blood cancer drug Iclusig (ponatinib) have been halted following reports that of serious and fatal adverse events associated with the drug.

About Iclusig

  • Iclusig is currently the only drug that pharmaceutical company Ariad has on the market, making up the majority of the company's $351.9 million market value as recorded in June.
  • The drug was approved by the FDA in December for the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).
  • Ariad was looking to expand the use of its drug, testing it as a possible treatment for a variety of other cancers when clinical trials were place on a partial hold last week.
  • Ariad followed up by issuing a release to investors stating that treatments would continue for patients enrolled in there EPIC clinical studies.

Iclusig EPIC Trials Halted

  • According to Bloomberg, Ariad is now putting a stop to the EPIC clinical trials following new data showing significant risk of blood clots, heart problems, loss of blood flow and decreased vision.
  • While Iclusig was originally approved by the FDA as part of an accelerated approval program which relied on a single trial showing that people were helped by treatment, further data suggested that at least 20 percent of patients treated with Iclusig developed blood clots or narrowing of blood vessels.
  • The EPIC trial was testing Iclusig as an alternative to Novartis AG’s Gleevec in the treatment of newly diagnosed chronic myeloid leukemia. 
  • EPIC clinical trials were conducted at facilities nationwide with three studies being conducted in  Houston, Texas.
  • Iclusig is still on the market as the Ariad attempts to negotiate label changes with regulators, but analysts suspect the drug will likely be relegated to emergency use only.
Adverse Events Linked to Iclusig

Information provided by the FDA:

  • Heart attack
  • Blood clots
  • Narrowing of blood vessels
  • Congestive heart failure
  • Loss of blood flow resulting in tissue death and amputation
  • Decreased vision
  • Death
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