Ariad公司于周三表示，美国食品和药物管理局已同意优先，或6个月，对其实验性白血病药物ponatinib进行审核。
该药物审核截止日期为2013年3月27日。美国食品和药物管理局通常需要10个月的时间来审查药物的应用，但对治疗取得重大进展或治疗短缺的药物要求时限较短。 
Generic Name and Formulations:
Ponatinib 15mg, 45mg; tabs.

Company:
ARIAD Pharmaceuticals, Inc.
Indications for ICLUSIG:
Chronic, accelerated, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy. Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is resistant or intolerant to prior TKI therapy.

Adult Dose for ICLUSIG:
Swallow whole. ≥18yrs: 45mg once daily. Concomitant strong CYP3A inhibitors: reduce to 30mg once daily. Dose modification for hematologic and non-hematologic toxicity: see full labeling.

Children's Dose for ICLUSIG:
<18yrs: not established.

Pharmacological Class:
Kinase inhibitor.

Warnings/Precautions:
Risk of arterial thrombosis; interrupt and consider discontinuing if occurs. Monitor hepatic function prior to and during therapy; interrupt and then reduce or discontinue therapy for hepatotoxicity. Moderate-to-severe hepatic impairment: not recommended. Monitor for CHF, hypertension, fluid retention, cardiac arrhythmias: treat as clinically indicated. Risk of pancreatitis; check serum lipase every 2 weeks for the first 2 months and then monthly thereafter or as clinically indicated. Interrupt therapy for serious or severe hemorrhage. Obtain CBCs every 2 weeks for the first 3 months, then monthly or as clinically indicated. Tumor lysis syndrome; ensure adequate hydration and treat uric levels prior to therapy. Compromised wound healing (withhold for 1 week prior to major surgery) and GI perforation. Elderly. Pregnancy (Cat. D); avoid. Nursing mothers: not recommended.

Interactions:
Potentiated by strong CYP3A inhibitors (eg, boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole); see Adult dose. Avoid concomitant strong CYP3A inducers (eg, carbamazepine, rifampin, phenytoin, St. John’s Wort), or drugs that elevate gastric pH (eg, PPIs, H2 blockers, antacids). Caution with concomitant P-gp and ABCG2 substrates.

Adverse Reactions:
Hypertension, rash, abdominal pain, fatigue, headache, dry skin, constipation, arthralgia, nausea, pyrexia, anemia, thrombocytopenia, neutropenia, leukopenia.

Metabolism:
Hepatic (CYP3A4, 2C8, 2D6, 3A5); 99% protein bound.

Elimination:
Fecal.

Generic Availability:
NO

How Supplied:
Tabs 15mg—60, 180; 45mg—30, 90