Posted by Michael Wonder on 30 Nov 2016
Ariad announces FDA full approval and label update for Iclusig (ponatinib) based on long-term efficacy and safety data from Phase 2 PACE clinical trial
29 November 2016 - Full approval granted through completion of accelerated approval commitments for rare cancer patients who may have no other targeted treatment options.
ARIAD Pharmaceuticals today announced that the U.S. FDA has granted Iclusig (ponatinib hydrochloride) full approval for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated; and for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I positive Ph+ ALL.
Iclusig was initially approved in December 2012 under the FDA’s accelerated approval program, which provides patients earlier access to promising new drugs that treat serious conditions based on a surrogate endpoint while the company conducts additional studies to confirm the drug’s clinical benefit. The therapy was granted the FDA’s orphan drug designation because it is intended to treat a rare disease or condition.
