Reactions 1484, p3 - 18 Jan 2014

Ponatinib to be marketed againfollowing new safety measures

The US FDA requires several new safety measures forponatinib [Iclusig] to address the risk of serious adverseevents, such as arterial and venous thrombosis andocclusions.

ARIAD Pharmaceuticals, the manufacturer of theIclusig, agreed to suspend marketing and sales of theagent upon the FDA’s request, made in October 2013,*following an investigation that revealed that theproportion of ponatinib recipients experiencing vascularocclusion events was significantly greater than thatreported at the time of drug approval in December2012.**

The new safety measures include label changes tonarrow the indication to the treatment of adult patientswith: T3151-positive chronic myeloid leukaemia(chronic, accelerated or blast phase); T3151-positivePhiladelphia chromosome-positive acute lymphoblasticleukaemia (Ph+ ALL); or chronic myeloid leukaemia(chronic, accelerated or blast phase) or Ph+ ALL forwhom no other tyrosine kinase inhibitor therapy isindicated. Additional information is required in the labelregarding the risk of vascular occlusion events. Therecommendations about dosage and administration ofponatinib and the patient Medication Guide will alsoneed to be revised and updated. It is anticipated that thenew safety measures will be in place by the end ofJanuary 2014, and ARIAD is expected to resumemarketing the agent to appropriate patients.* see Reactions 1477 p2; 803095471** see Reactions 1474 p2; 803094644

FDA. FDA Drug Safety Communication: FDA requires multiple new safetymeasures for leukemia drug Iclusig; company expected to resume marketing.Internet Document : 20 Dec 2013 803097668

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Reactions 18 Jan 2014 No. 14840114-9954/14/1484-0001/$14.95 Adis © 2014 Springer International Publishing AG. All rights reserved