Ponatinib: Accelerated disapproval

Oncologist

Volumn 20, Issue 8, 2015, Pages 847-848

  Gainor, Justin F ^a   Chabner, Bruce A ^a  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PONATINIB; ANTINEOPLASTIC AGENT; IMIDAZOLE DERIVATIVE; PYRIDAZINE DERIVATIVE;

CARDIOVASCULAR DISEASE; DRUG APPROVAL; DRUG DOSE; DRUG SAFETY; EDITORIAL; HUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; DRUG DEVELOPMENT; PROCEDURES;

ANTINEOPLASTIC AGENTS; DRUG DISCOVERY; HUMANS; IMIDAZOLES; PYRIDAZINES;

EID: 84940037310     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2015-0253     Document Type: Editorial

References (8)

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4. Cortes JE, Kantarjian H, Shah NP et al. Ponatinib in refractory Philadelphia chromosome-positive leukemias. N Engl J Med 2012;367:2075–2088.
5. UnitedStatesFoodandDrugAdministration. FDA Drug Safety Communication: FDA asksmanufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales. Available at http://www.fda.gov/drugs/drugsafety/ucm373040.htm. Accessed June 17, 2014.
6. Ariad Pharmaceuticals. Ariad announces the commercial availability of Iclusig (ponatinib) forpatientswith refractory Philadelphia-Positive Leukemias in the U.S. Available at http://investor.ariad.com/mobile.view?c5118422&v5203&d51&id51891697. Accessed March 12, 2015.
7. Lipton J, Chuah C, Guerci-Bresler A et al. EPIC: A phase 3 trial of ponatinib compared with imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CP-CML). Blood 2014;124:519.
8. Knickerbocker R, Dorer D, Haluska F et al. Impact of dose intensity of ponatinib on selected adverseevents:Multivariateanalysis fromapooled population of clinical trial patients. Blood 2014; 124:4546.