STA wins TGA approval for Iclusig in leukaemia

ARIAD Pharmaceuticals and Specialised Therapeutics Australia have won TGA approval for Iclusig as a leukaemia treatment.

The TGA has awarded marketing approval for the drug for the treatment of adult patients with chronic myeloid leukaemia (CML) or Philadelphia-chromosome positive acute lymphoblastic leukaemia (PH+ALL) whose disease is resistant to certain prior treatments.

The drug is expected to be commercially launched in early 2015. STA will distribute the drug in Australia and work with ARIAD to get the treatment in the hands of patients.

“Up to 30% of patients with CML become resistant to current therapies, and patients with resistant disease eventually run low on treatment options,” said professor Timothy Hughes, consulting haematologist at the Royal Adelaide Hospital.

“Iclusig will be a valuable new therapy for refractory leukaemia patients and treating clinicians in Australia.”

During the phase IIb trial used by the TGA to make its decision, Inclusig demonstrated significant anti-leukaemic activity in 54% of CML and 70% of patients with the T315I mutation.

In patients with advanced disease, 57% of accelerated-phase CML patients and 34% of blast-phase CML patients achieved a major haematologic response.

“Iclusig provides a new treatment option for patients with difficult-to-treat CML or Ph+ ALL who previously had limited therapies available to them,” STA CEO Carlo Montagner said.