強(qiáng)生宣布銳珂?（埃萬妥單抗注射液）在華獲批一線治療EGFR 20號(hào)外顯子插入突變的局部晚期或轉(zhuǎn)移性非小細(xì)胞肺癌患者

2025/02/11

??強(qiáng)生公司宣布，旗下創(chuàng)新治療藥物銳珂?（埃萬妥單抗注射液）正式獲得國家藥品監(jiān)督管理局批準(zhǔn)，與卡鉑和培美曲塞聯(lián)合給藥，用于經(jīng)檢測確認(rèn)攜帶表皮生長因子受體（EGFR）20號(hào)外顯子插入突變的局部晚期或轉(zhuǎn)移性非小細(xì)胞肺癌（NSCLC）成人患者的一線治療[1]。此次獲批標(biāo)志著強(qiáng)生在華正式進(jìn)軍肺癌治療領(lǐng)域，有望重新定義治療標(biāo)準(zhǔn)、開創(chuàng)肺癌治療的新時(shí)代。

??此次埃萬妥單抗的獲批是基于一項(xiàng)隨機(jī)、開放標(biāo)簽、PAPILLON臨床Ⅲ期研究結(jié)果。該研究表明，與單獨(dú)化療相比，埃萬妥單抗聯(lián)合化療可將疾病進(jìn)展或死亡風(fēng)險(xiǎn)降低61% [2]。基于PAPILLON臨床試驗(yàn)結(jié)果，美國國家綜合癌癥網(wǎng)絡(luò)（NCCN）《NCCN臨床實(shí)踐指南》推薦埃萬妥單抗聯(lián)合化療作為EGFR 20號(hào)外顯子插入突變非小細(xì)胞肺癌患者的首選一線治療方案[3]。

??肺癌在我國所有惡性腫瘤中發(fā)病率和死亡率均居首位[4]。據(jù)統(tǒng)計(jì)，我國每年肺癌的新發(fā)病例超過100萬例，占全球肺癌患者總數(shù)的三分之一以上[5],[6]。非小細(xì)胞肺癌是最常見的肺癌類型，約占所有肺癌的85%[7]。其中，EGFR基因突變是非小細(xì)胞肺癌中最常見的驅(qū)動(dòng)基因，我國約有40%的患者攜帶這一突變類型[8]。目前有25%-40%的EGFR突變患者因病程進(jìn)展嚴(yán)峻無法進(jìn)入二線治療[9],[10]。EGFR 20號(hào)外顯子插入突變是第三大常見的突變類型[11]。通常，由該突變驅(qū)動(dòng)的非小細(xì)胞肺癌相較于EGFR常見突變驅(qū)動(dòng)的肺癌患者，其預(yù)后更差，生存期更短[12]。研究顯示，攜帶EGFR 20號(hào)外顯子插入突變的NSCLC患者對(duì)目前已獲批上市的第三代EGFR-TKI靶向藥物和化療的療效有限，患者普遍預(yù)后較差，面臨生存期和生存質(zhì)量的雙重挑戰(zhàn)[13],[14]。因此，在一線治療階段為患者提供更加有效的治療方案至關(guān)重要。

??強(qiáng)生創(chuàng)新制藥中國區(qū)總裁Cherry Huang女士表示：“肺癌是中國第一大癌癥，其治療仍然存在很大的未滿足需求，亟待更加有效的治療方式。銳珂?的到來將為EGFR突變非小細(xì)胞肺癌患者帶來更多生存希望，有望進(jìn)一步重塑我國非小細(xì)胞肺癌治療格局。此次獲批也標(biāo)志著強(qiáng)生在華正式進(jìn)入肺癌領(lǐng)域，實(shí)現(xiàn)了在精準(zhǔn)醫(yī)療領(lǐng)域的重要突破。深耕腫瘤領(lǐng)域30余年，強(qiáng)生始終站在癌癥防治第一線，我們希望推動(dòng)讓腫瘤成為可控、可治的慢性疾病，并引領(lǐng)探索治愈腫瘤的可能。“

CP-502816, Approved Date: 2025-02-11

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