美国FDA于2015年12月11日批准Genentech公司生产的Alecensa（alectinib）用于治疗ALK（anaplastic lymphoma kinase,间变性淋巴瘤激酶）阳性的晚期转移性非小细胞肺癌（NSCLC）,适用于对Xalkori（crizotinib,辉瑞公司出品）不耐受或经Xalkori治疗后病情继续恶化的肺癌患者。
Alecensa(Alectinib Hydrochloride)
Generic Name and Formulations:
Alectinib 150mg; caps.
Company:
Genentech, Inc.
Select therapeutic use: Respiratory and thoracic cancers
Indications for ALECENSA:
Treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
Adult:
Swallow whole. Take with food. 600mg twice daily until disease progression or unacceptable toxicity. Dose modifications or dose reduction schedule: see full labeling.
Children:
Not established.
Warnings/Precautions:
Monitor liver function tests (eg, ALT, AST, total bilirubin) every 2 weeks for the first 2 months, then periodically during treatment; test more frequently if transaminase and bilirubin elevated; withhold, resume at reduced dose, or permanently discontinue based on severity. eva luate if presence of worsening respiratory symptoms; withhold if ILD/pneumonitis diagnosed; permanently discontinue if no other cause identified. Monitor HR, BP regularly. If non-life-threatening symptomatic bradycardia occurs, withhold until asymptomatic or HR ≥60bpm; permanently discontinue in case(s) of recurrence or life-threatening bradycardia if no contributing concomitant medication identified. Assess CPK every 2 weeks for the first month and as clinically indicated; withhold, resume, or reduce dose based on severity. Pregnancy. Females of reproductive potential should use effective contraception during treatment and for 1 week after final dose; males should use effective contraception during treatment and for 3 months after final dose. Nursing mothers: not recommended (during and for 1 week after final dose).
Interactions:
Increased bradycardia with concomitant antihypertensives or other drugs known to cause bradycardia.
Pharmacological Class:
Kinase inhibitor.
Adverse Reactions:
Fatigue, constipation, edema, myalgia; hepatotoxicity, ILD/pneumonitis, bradycardia, CPK elevation, embryo-fetal toxicity.
Generic Availability:
NO
How Supplied:
Caps—240
Company: Hoffmann-La Roche, Inc.
Application No.: 208434
Approval Date: 12/11/2015
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