Established TKI Gains New Indication to Treat Aggressive Cancer

After first gaining approval more than a decade ago, Takeda Pharmaceuticals U.S.A., Inc.’s Iclusig (ponatinib) recently gained approval for the frontline treatment of an aggressive blood cancer. One clinical trial found that people on the agent experienced complete remission more than twice as often as those on a comparator therapy. Industry sources point to the drug’s clinical efficacy as a significant development in the treatment of the disease.

On March 19, the FDA gave accelerated approval to Iclusig in combination with chemotherapy for the treatment of adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The newest application had priority review and orphan drug designation, and its review used the Real-Time Oncology Review and the Assessment Aid.