FDA Approval Insights: Ponatinib in Ph+ ALL

Welcome to OncLive On Air^®! I’m your host today, Courtney Flaherty.

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, sponsored by Takeda, we had the pleasure of speaking with Elias Jabbour, MD, about the significance of the FDA approval of ponatinib (Iclusig) plus reduced-intensity chemotherapy for patients with newly diagnosed Philadelphia chromosome (Ph)–positive acute lymphoblastic leukemia (ALL). Dr Jabbour is a professor of medicine in the Department of Leukemia in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston.

On March 19th, 2024, the FDA granted accelerated approval to ponatinib plus chemotherapy for the treatment of patients in this population based on data from the phase 3 PhALLCON trial (NCT03589326). Treatment with first-line ponatinib plus reduced-intensity chemotherapy produced a minimal residual disease (MRD)–negative complete response (CR) rate of 30% at the end of induction in efficacy-evaluable patients (n = 164); this rate was 12% in evaluable patients treated with imatinib (Gleevec) plus chemotherapy (n = 81; risk difference, 0.18; 95% CI, 0.08-0.28; P = .0004). Moreover, 79% of evaluable patients in the ponatinib arm achieved CRs at the end of induction therapy vs 63% of patients in the imatinib arm.

The addition of ponatinib to the ALL treatment arsenal marks the first FDA approval of a TKI/chemotherapy regimen for first-line use in this disease, and the first FDA authorization supported by the assessment of MRD following induction.

In our exclusive interview, Dr Jabbour expanded on the multiple milestones achieved through ponatinib’s approval in Ph-positive ALL, the agent’s potency and unique mechanism of action, and key efficacy and safety data from the PhALLCON trial supporting this regulatory decision.

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