dm+d

703798002

New Medicines

IclusigPhiladelphia chromosome positive acute lymphoblastic leukaemia (ALL) - first-line

Information

Iclusig
Licence extension / variation
Incyte
Takeda Oncology

Development and Regulatory status

None
Pre-registration (Filed)
Phase III Clinical Trials
Yes
Yes
Aug 22EMA CHMP begins evaluating an application for an extension of indication to include treatment of newly diagnosed adult patients with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL), either with Iclusig (ponatinib) in combination with chemotherapy, or with Iclusig monotherapy after corticosteroid induction in patients not eligible to receive chemotherapy-based regimens, based on final results from studies AP24534-11-001 and INCB 84344-201 [7].
Mar 19Has orphan drug status in EU & US [2].

Category

BCR-ABL kinase inhibitor including T315I mutations
ALL is the most common cancer in children. Global incidence is about 3 per 100,000 population, with about 3 out of 4 cases occurring in children aged under 6 years [1].
Philadelphia chromosome positive acute lymphoblastic leukaemia (ALL) - first-line
Oral

Trial or other data

Nov 21Recruitment continues in PIII trial (NCT03589326) (with a reduced target enrolment of 230 participants), and collection of primary outcome data should now finish Jun 22 [6].
Dec 20PIII trial (NCT03589326) is still recruiting, and has extended to other countries (although not the UK) [5].
Nov 19PIII trial (NCT03589326) is recruiting; collection of primary outcome data should now finish May 21 [4].
Aug 18PIII trial to compare the efficacy of ponatinib versus imatinib, administered as first-line therapy in combination with reduced-intensity chemotherapy, in participants with newly diagnosed philadelphia chromosome-positive ALL starts (NCT03589326). Evaluation of the number of participants with minimal residual disease-negative complete remission is the defined primary endpoint of the trial. The open label trial intends to enrol approximately 320 patients in the US & Spain. Collection of primary outcome data is due to complete Jul 20 [2].