英文药名：Lorbrena(lorlatinib tablets)

中文药名：劳拉替尼片

研发生产：辉瑞公司
药品介绍；
肺癌新药LORBRENA（lorlatinib）—第三代间变性淋巴瘤激酶（ALK）酪氨酸激酶抑制剂（TKI）
关健词：劳拉替尼片 lorlatinib 商品名LORBRENA 间变性淋巴瘤激酶（ALK）酪氨酸激酶抑制剂（TKI），肺癌新药
2018年11月6日,美国食品和药物管理局（FDA）已批准第三代间变性淋巴瘤激酶（ALK）酪氨酸激酶抑制剂（TKI）Lorbrena（lorlatinib），用于ALK阳性转移性非小细胞肺癌（NSCLC）患者的治疗，具体为：（1）接受第一代ALK抑制剂Xalkori（crizotinib，克唑替尼）及至少一种其他ALK抑制剂治疗转移性疾病后病情进展的患者；（2）接受第二代ALK抑制剂alectinib（品牌名：Alecensa，诺华制药）或certinib（品牌名：Zykadia，罗氏制药）一线治疗转移性疾病后病情进展的患者。
辉瑞全球产品开发肿瘤学首席开发官Mace Rothenberg表示，自从2011年首次批准了ALK阳性NSCLC的生物标志物驱动疗法以来，辉瑞的科学家和临床医生一直致力于研发能够进一步促进患者生存的药物。Lorbrena的获批对患者来说是一个重要的里程碑，该药在ALK阳性NSCLC的广泛群体中表现出了显著的疗效，包括已过度治疗及接受第一代和第二代ALK-TKI后病情进展治疗选择非常有限的患者群体。
目前，Lorbrena也已获日本批准，用于对ALK-TKI耐药或不耐受的ALK融合基因阳性不可切除性晚期和/或复发性NSCNC患者
LORBRENA(lorlatinib) tablets, for oral use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
LORBRENA is a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on
crizotinib and at least one other ALK inhibitor for metastatic disease; or
alectinib as the first ALK inhibitor therapy for metastatic disease; orceritinib as the first ALK inhibitor therapy for metastatic disease.
This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage is 100 mg orally once daily. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg or 100 mg. (3)
CONTRAINDICATIONS
Concomitant use with strong CYP3A inducers. (4)
WARNINGS AND PRECAUTIONS
Risk of Serious Hepatotoxicity with Concomitant Use of Strong CYP3A Inducers: Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating LORBRENA. (2.3, 5.1)
Central Nervous System (CNS) Effects: CNS effects include seizures, hallucinations and changes in cognitive function, mood (including suicidal ideation), speech, mental status, and sleep. Withhold and resume LORBRENA at same or reduced dose or permanently discontinue LORBRENA based on severity. (2.2, 5.2)
Hyperlipidemia: Initiate or increase the dose of lipid-lowering agents. Withhold and resume LORBRENA at same or reduced dose based on severity. (2.2, 5.3)
Atrioventricular Block: Withhold and resume LORBRENA at same or reduced dose based on severity. (2.2, 5.4)
Interstitial Lung Disease/Pneumonitis: Immediately withhold LORBRENA in patients with suspected ILD/pneumonitis. Permanently discontinue LORBRENA for treatment-related ILD/pneumonitis of any severity. (2.2, 5.5)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus. Advise males and females of reproductive potential to use an effective non-hormonal method of contraception. (5.6, 7.2, 8.1, 8.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥20%) are edema, peripheral neuropathy, cognitive effects, dyspnea, fatigue, weight gain, arthralgia, mood effects, and diarrhea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or www.pfizer.com or FDA at 1-800-FDA-1088 or ww