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TAGRISSO(osimertinib/AZD9291) 塔格瑞斯

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软件语言:  简体中文  更新时间:  2016-07-08 
版本号:  1.0  软件平台:  Win2000/WinXP/Win2003 
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TAGRISSO™ (osimertinib) (AZD9291) approved by the US FDA as treatment for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer
US Food and Drug Administration (FDA) has approved TAGRISSO™ (osimertinib) (AZD9291) 80mg once-daily tablets for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
TAGRISSO is the only approved medicine indicated for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer. This indication is approved under the FDA’s accelerated approval process based on tumor response rate and duration of response (DoR).
TAGRISSO is an EGFR-TKI, a targeted cancer therapy, designed to inhibit both the activating, sensitizing mutations (EGFRm), and T790M, a genetic mutation responsible to EGFR-TKI treatment resistance. Nearly two-thirds of NSCLC patients who are EGFR mutation-positive and experience disease progression after being treated with an EGFR-TKI develop the T790M resistance mutation, for which there have been limited treatment options.
TAGRISSO Rx
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TAGRISSO
Respiratory and thoracic cancers  Only 4 drugs may be compared at once
Generic Name and Formulations:
Osimertinib 40mg, 80mg; tabs.
Company:
AstraZeneca Pharmaceuticals
 
Select therapeutic use: Respiratory and thoracic cancers
Indications for TAGRISSO:
Treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor therapy.

Adult:
80mg once daily until disease progression or unacceptable toxicity. If swallowing difficulty, may disperse tab in 4tbsps (~50mL) of non-carbonated water only; stir and swallow immediately or give through NG tube; then rinse container with 4–8oz water and drink immediately or give through NG tube. Dose modification: see full labeling.

Children:
Not established.

Warnings/Precautions:
Confirm presence of T790M mutation prior to treatment initiation. Permanently discontinue if interstitial lung disease (ILD)/pneumonitis is confirmed; QTc interval prolongation with signs/symptoms of life-threatening arrhythmia; persistent, asymptomatic LV dysfunction that does not resolve within 4 weeks; symptomatic CHF; or if no improvement of Grade ≥3 adverse reaction within 3 weeks occurs. Withhold dose if worsening respiratory symptoms indicative of ILD occur or if QTc interval >500msec on ≥2 separate ECGs. Monitor ECGs and electrolytes periodically in patients with congenital long QTc syndrome, CHF, electrolyte abnormalities, or those who are taking drugs known to prolong the QTc interval. Assess LVEF by echocardiogram or MUGA scan prior to initiation and every 3 months during treatment. Severe renal impairment (CrCl <30mL/min) or ESRD. Moderate or severe hepatic impairment. Pregnancy. Females of reproductive potential should use effective contraception during and for 6 weeks after final dose; males with female partners of reproductive potential should use effective contraception during and for 4 months after final dose. Nursing mothers: not recommended (during and for 2 weeks after final dose).

Interactions:
Avoid concomitant with strong CYP3A inhibitors (eg, telithromycin, itraconazole, ritonavir, nefazodone); if no other alternative, monitor closely. Avoid concomitant with strong CYP3A inducers (eg, phenytoin, rifampicin, carbamazepine, St. John’s Wort). Avoid concomitant with sensitive substrates of CYP3A, BCRP, or CYP1A2 with narrow therapeutic indices (eg, fentanyl, cyclosporine, quinidine, ergots, phenytoin, carbamazepine).

Pharmacological Class:
Kinase inhibitor.

Adverse Reactions:
Diarrhea, rash, dry skin, nail toxicity.

Generic Availability:
NO

How Supplied:
Tabs—30
TAGRISSO (OSIMERTINIB)在肺癌所致软脑脊膜病患者中显示临床活性
ASCO 2016上报告的数据显示,osimertinib可改善EGFRm NSCLC和软脑脊膜病患者的神经系统功能
最新结果再次印证了osimertinib能够穿越血脑屏障的临床前证据
英国剑桥 -- (美国商业资讯) -- 阿斯利康(AstraZeneca)今天发布了Tagrisso (osimertinib)在软脑脊膜(LM)病患者中的临床及安全性数据,该病是表皮生长因子受体(EGFR)突变阳性晚期非小细胞肺癌(NSCLC)癌细胞扩散至脑脊液(CSF)所致的并发症。LM是一种与晚期肺癌相关的摧毁性疾病。
美国临床肿瘤学会(ASCO)年会上呈报的BLOOM I期试验更新结果显示,无论患者的T790M状态如何,osimertinib均可导致MRI信号强度变化,提示中枢神经系统(CNS)病灶缩小。
21例采用osimertinib 160毫克每天一次治疗的患者数据显示,7例患者有颅内放射学改善,5例患者有神经系统功能改善,2例患者连续2次访视中CSF未检出肿瘤细胞。121例osimertinib治疗患者中,无人接受合并放疗或鞘内化疗。数据截止时(2016年3月10日),15例患者仍在治疗,其中7例治疗时间超过9个月。
BLOOM研究的进一步数据显示,osimertinib可穿越血脑屏障。9例患者中有6例观察到CSF中EGFR突变水平降幅超过50%,此降低持续至治疗的第9个周期的第1天,其中5例观察到持续降低。上述结果支持既往报道的osimertinib穿越血脑屏障的临床前数据。
台北国立台湾大学医院、国立台湾大学癌症研究中心的杨志新(James CH Yang)博士说:“软脑脊膜病的预后极差,因此,osimertinib中观察到的安全性、耐受性和活性令人鼓舞。BLOOM研究中,我们发现软脑脊膜病患者的中枢神经系统病灶有缩小,同时伴有神经系统改善。
该结果印证了osimertinib在临床前及临床研究中的既往结果,证明了osimertinib在伴有中枢神经系统转移的难治性患者中的前景。”
在软脑脊膜病中,癌细胞扩散至包裹脑和脊索的膜上。该病目前采用全身或鞘内化疗、全脑放疗或EGFR酪氨酸激酶抑制剂(TKI),中位总生存期4.5-11个月。但多数现有EGFR-TKI穿越血脑屏障的能力有限,无法有效治疗或预防脑转移。
osimertinib 160毫克在最长达11个月的治疗期间耐受性可处治。患者最常报告的不良事件有腹泻(58%总体;5% ≥3级)、恶心(48%总体;0% ≥3级)和皮疹(43%总体;0% ≥3级)。间质性肺病、高血糖或QT延长病例未见报告。
osimertinib最近在美国、欧盟、日本和以色列获得加快核准,首个适应证是治疗EGFR T790M突变阳性局部进展/转移性NSCLC患者。韩国也已核准osimertinib用于同一适应证。
阿斯利康致力于探索osimertinib在肺癌中的全部潜力,包括辅助治疗和局部进展/转移性EGFRm一线治疗、有或无脑转移的患者以及伴软脑脊膜病的患者。
关于非小细胞肺癌(NSCLC)
肺癌是男女癌症的主要死因,约占所有癌症死因的三分之一,高于乳腺癌、前列腺癌和结直肠癌之和。EGFRm型NSCLC患者占欧洲NSCLC患者的10-15%,占亚洲NSCLC患者的30-40%,对现有的EGFR-TKIs类药物特别敏感,此类药物可阻断促进肿瘤细胞生长的细胞信号传递通路。不过,肿瘤几乎都会发生耐药,导致疾病进展。在接受吉非替尼和厄洛替尼等已获准的EGFR-TKIs治疗的患者中,约三分之二发生的耐药由T790M继发突变所致。
关于软脑脊膜病
在软脑脊膜病中,癌细胞扩散至包裹脑和脊索的膜上。它是一种并发症,累及3-5%的NSCLC患者,以及9%的EGFRm NSCLC患者。治疗具有挑战性,因为多数EGFR-TKI治疗药物难以穿越血脑屏障,使药物难以达到脑和脊索。EGFRmNSCLC和软脑脊膜病患者的平均生存期介于4.5至11个月。最近报道的“真实世界”回顾性分析中,EGFRm NSCLC患者采用EGFR-TKIs治疗,总生存期约为30个月。
关于osimertinib
osimertinib 80毫克每天一次片剂是首个适用于局部进展或转移性EGFR T790M突变阳性NSCLC成人患者的药物。非临床体外研究显示,在有临床意义的EGFR和T790M突变型NSCLC细胞株中,osimertinib具有抗击突变型EGFR磷酸化的高效价和抑制活性,而其抗击野生型细胞株EGFR的活性显著较小。
证实性III期AURA3研究在EGFR T790M突变阳性、局部进展或EGFR-TKI治疗后进展的转移性NSCLC患者中比较osimertinib与含铂两药化疗方案。18该药也在研究用于辅助和转移性一线治疗,包括有和无脑转移的患者、软脑脊膜病、以及联合治疗。
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5e81b4a7-b971-45e1-9c31-29cea8c87ce7

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