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news.Contract Pharmaceutical Manufacturer Ash Stevens (ASI) has received approval from the US Food and Drug Administration (FDA) to allow its Riverview facility in Michigan to manufacture the Active Pharmaceutical Ingredient (API) in ARIAD Pharmaceuticals's oncology drug Iclusig (ponatinib).
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The FDA approved the drug on December 14, 2012 for the treatment of adult patients with chronic, accelerated or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.
Ash Stevens presidebt and CEO Dr. Stephen A. Munk said, "We are very proud to be ARIAD Pharmaceuticals’ outsourcing partner for the development and manufacture of this important API.
"We have a collaborative and highly productive relationship with ARIAD and we are excited to help provide this innovative therapy to cancer patients."
Ponatinib is ASI’s twelfth manufacturing approval for an innovator or NCE (New Chemical Entity) drug and the company’s fourth FDA accelerated approval.