Doctors Fear Losing Leukemia Drug Deemed Risky

For those in the EU, the EMA is actively reviewing our proposed changes to the Iclusig label and we cannot comment or speculate as to whether the EMA will have different views compared to FDA. Iclusig (ponatinib) is commercially available in the EU and up until such time as the EMA approves any label changes, the current Iclusig label remains valid.

EU prescribers have been alerted to the risks observed in clinical studies with Iclusig (ponatinib).

For those in the US, today ARIAD is sending a letter to US prescribers announcing that beginning immediately Iclusig is no longer available for sale in the US. The letter goes on to provide details on the actions that healthcare professionals need to take for Iclusig patients (existing or new), along with guidance on how to access Iclusig for patients (existing or new) for whom physicians feel the potential benefit of treatment outweighs the risk of serious adverse events. Below is language from that letter:

· Patients currently taking Iclusig who are not responding to treatment should be immediately discontinued and counseled on alternative treatment options.

· Patients currently taking Iclusig who are responding to treatment and for whom physicians have made the determination that the potential benefit of continued treatment outweighs the risks of safety events can access Iclusig under a single-patient IND application (more details below).

· New patients who have failed all other available therapies and have no other treatment options may be considered for treatment with Iclusig under a single-patient IND application

For the immediate future, a single-patient IND is the only mechanism to access Iclusig in the US.
Background information on the single-patient IND application process is on the following FDAwebsite:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDeveloped...

ARIAD will help facilitate the application process by providing HCPs with a package containing all the relevant information required to complete the application, along with a letter cross-referencing the Iclusig IND.
Iclusig will be shipped upon FDA approval of the application. To initiate a single patient IND request, physicians can contact ARIAD at 1-855-55-ARIAD (855-552-7423).
We will respond with information to assist with the application.
ARIAD continues to collaborate with the FDA on other solutions to access Iclusig.

For those outside of the EU and US, we have no update at this time.

For all patients enrolled in or considering a clinical trial with ponatinib anywhere in the world, the temporary clinical hold is still in place, thus no new patients are being enrolled.
Patients who are on study should be communicating with their physician. Our clinical investigators have been alerted to the risks observed in clinical studies with Iclusig (ponatinib).