LLS Issues Statement Regarding the FDA and Iclusig


The Leukemia & Lymphoma Society (LLS) has issued a statement on the FDA's call for Ariad Pharmaceuticals to suspend marketing and sales of its therapy for chronic myeloid leukemia (CML), Iclusig (ponatinib).

As reported yesterday, the FDA is investigating serious health risks associated with Iclusig and consequently issued recommendations to patients either on the drug or with CML.

Discussing medical risks

In accord with those recommendations, the LLS is encouraging all patients currently receiving Iclusig to discuss the risks and benefits of continuing to take the drug with their doctor. Patients responding to the drug and who have no other alternatives can obtain it on a compassionate use basis, but need to speak with their oncologists immediately.

The LLS has an information resource center available for patients to call Monday through Friday from 9 a.m. to 6 p.m. ET at 1-800-955-4572 for questions and concerns.

Mark Velleca, M.D., Ph.D., chief policy and advocacy officer for LLS, added:

The Leukemia & Lymphoma Society exists to find cures and ensure access to treatments for blood cancer patients. As such, we felt it was important to comment on this important access issue. Working with CML physicians and other advocacy groups, we have requested that FDA facilitate continued access to ponatinib for certain patients – such as those in blast crisis – for whom interruption of therapy could be extremely detrimental.

Source: LLS

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